A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

开始日期2022-04-21

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05352893

/ Completed临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

开始日期2022-04-14

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT04856930

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

开始日期2021-07-07

申办/合作机构

Vanda Pharmaceuticals, Inc.

100 项与 Imsidolimab 相关的临床结果

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100 项与 Imsidolimab 相关的转化医学

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100 项与 Imsidolimab 相关的专利（医药）

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项与 Imsidolimab 相关的文献（医药）

2026-04-28·NEJM evidence

Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis

Article

作者: Randazzo, Bruce ; Dahl, Martin ; Parmley, Stephen ; Johnson, Caroline ; Lizzul, Paul ; Brzezynski, Jennifer ; Birznieks, Gunther ; Tyner, Christina ; Bachelez, Hervé ; Polymeropoulos, Christos ; Bushman, Margaret ; Xiao, Changfu ; Polymeropoulos, Mihael ; Saikali, Khalil ; Gudjonsson, Johann E. ; Severtson, Anne ; Yap, Evelyn Wen Yee ; Denguezli, Mohamed ; Borlu, Murat ; Przychodzen, Bartlomiej ; Smieszek, Sandra ; Reich, Adam ; Chaowattanapanit, Suteeraporn ; Raina, Priya

BACKGROUND:

Generalized pustular psoriasis (GPP) is a rare, life-threatening disease attributed to aberrant interleukin-36 (IL-36) activity, often due to variants in the IL-36 receptor antagonist gene. Imsidolimab is a novel, humanized, affinity-matured immunoglobulin G4 monoclonal antibody that binds the IL-36 receptor and antagonizes IL-36 signaling.

METHODS:

Two phase 3 trials were conducted at 26 clinical sites within 11 countries investigating imsidolimab treatment for GPP. GEMINI-1 was a double-blind, placebo-controlled trial that randomly assigned 45 patients (18-80 years of age) with a GPP flare to receive either a single intravenous dose of 300 mg of imsidolimab, 750 mg of imsidolimab, or placebo. The primary endpoint was GPP Physician Global Assessment (GPPPGA) scores of clear (0) or almost clear (1) at week 4 (range: 0 [clear] to 4 [severe]; minimally clinically important difference, 1.4). GEMINI-2 was a follow-on relapse prevention trial with a primary objective of evaluating the safety of imsidolimab up to 104 weeks. Patients who improved with treatment in GEMINI-1 were randomly assigned to receive either 200 mg of subcutaneous imsidolimab or placebo monthly, whereas partial responders received open-label 200 mg of subcutaneous imsidolimab monthly.

RESULTS:

In GEMINI-1, 53% of patients in the groups that received either 300 mg (n=8/15) or 750 mg (n=8/15) of imsidolimab had GPPPGA scores of 0 or 1 at week 4, compared to 13% in the placebo group (n=2/15) (P=0.023 for both the 300 mg vs. placebo comparison and 750 mg vs. placebo comparison). In GEMINI-2, no serious adverse events led to imsidolimab discontinuation.

CONCLUSIONS:

Compared with placebo, a significantly higher proportion of patients with GPP randomly assigned to receive a single intravenous dose of imsidolimab were clear or almost clear of the disease after 4 weeks based on the GPPPGA. There were no serious adverse events that led to treatment discontinuation with imsidolimab up to 104 weeks of treatment. (Funded by AnaptysBio; ClinicalTrials.gov number, NCT05352893 for GEMINI-1 and NCT05366855 for GEMINI-2.).

2024-05-01·American journal of clinical dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

作者: Wu, Po-Chien ; Huang, Yu-Huei ; Huang, I-Hsin ; Chiu, Hsien-Yi

BACKGROUND:

The comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.

OBJECTIVE:

The aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.

METHODS:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.

RESULTS:

The study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.

CONCLUSION:

Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

2024-04-01·Journal of the American Academy of Dermatology

The expanding horizon of anti-IL-36 therapy

作者: Heymann, Warren R

A review.The IL-36 signaling pathway dermatol. revolution is underway.This pathway is key in the pathogenesis of generalized pustular psoriasis (GPP).The IL-36 receptor (IL-36R) antagonist spesolimab effectively manages GPP, rapidly controlling GPP flares and preventing their recurrence.A phase II trial of imsidolimab, a humanized IgG4 monoclonal antibody specifically binding IL-36R, demonstrated a rapid resolution of pustular eruptions in GPP patients.In this issue of the Journal of the American Academy of Dermatol. , the National Psoriasis Foundation asserts that 'GPP is a life-threatening disease that needs to be treated as quickly as possible'.A controversial point regarding spesolimab focuses on (whether) screening for tuberculosis should be performed when the drug has been prescribed.Ahmad et al state that 'IL-36 comprises 4 isoforms: the proinflammatory IL-36α, IL-36β, and IL-36γ, and the anti-inflammatory IL-36R antagonist.An imbalance between proinflammatory and anti-inflammatory IL-36 isoforms can contribute to the inflammatory fate of cells and tissues.Cutaneous IL-36 signaling is crucial for the immunopathol. outcome of various skin diseases.Consequently, the IL-36/IL-36R axis has recently been recognized as a promising drug target for the treatment of inflammatory disorders beyond psoriasis.A safe prediction is that IL-36 antagonists will be broadly used in medical dermatol. beyond the realm of GPP.

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项与 Imsidolimab 相关的新闻（医药）

2026-05-12

·ir.anaptysbio.com

Anaptys Announces First Quarter 2026 Financial Results and Provides Business Update

Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda Announced appointment of Chris Murphy as CFO Announced appointments of Susannah Gray , former CFO of Royalty Pharma, and Owen Hughes , current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO , May 12, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026 , and provided a business update. “Following the completion of the spin-off of First Tracks Bio in late April, Anaptys now exclusively manages the financial collaborations for Jemperli and imsidolimab, with streamlined operations requiring limited FTEs, minimal operating expenses and delivering an EBIT margin greater than 95%,” said Daniel Faga , president and chief executive officer. “With Chris Murphy joining as CFO, who brings deep business development and investment banking experience, our priority continues to be to protect our two royalty streams and return their value to shareholders.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli ( $313 million /£232 million in Q1 2026 sales, with >40% year-over-year growth1) Anaptys continues to expect to achieve > $390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak sales guidance of > $2.7 billion 2 Anaptys estimates Sagard will have accrued ~$275 million in royalties and sales milestones through Q1 2026 and anticipates paydown of the remaining ~$325 million non-recourse debt monetization by the end of Q2 20273 Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer Data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month sBLA review timeline for US FDA approval AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer Data expected in 2028 AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer Data expected in Q4 2026 JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 CPS≥1) post chemoradiation Data expected in 2028 Vanda Imsidolimab Financial Collaboration FDA target action date (PDUFA) of Dec. 12, 2026 for imsidolimab in generalized pustular psoriasis (GPP) Recent Leadership and Board of Directors Appointments Announced appointment of Chris Murphy as Chief Financial Officer (CFO) Mr. Murphy brings >20 years’ experience in business development, commercial operations, corporate strategy and investment banking in the biopharmaceutical industry Announced appointment of industry veterans Susannah Gray and Owen Hughes to Board of Directors Ms. Gray brings >25 years’ experience in both finance and investment banking in the biopharmaceutical industry, formerly CFO of Royalty Pharma Mr. Hughes brings >25 years’ experience as both an operator and investor in the biopharmaceutical industry, currently leading XOMA Royalty as CEO Stock Repurchase Plan Announced a $100.0 million Stock Repurchase Plan in March 2026 . It will expire on Dec. 31, 2026 , may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock First Quarter Financial Results The separation of Anaptys and First Tracks Bio was completed on April 20, 2026 . As a result, in the first quarter of 2026, the financial results include assets, liabilities and expenses related to both companies. Beginning in the second quarter of 2026, Anaptys expects to reclassify historical First Tracks Bio related assets, liabilities and expenses as discontinued operations. Cash, cash equivalents and investments totaled $286.5 million as of March 31, 2026 , compared to $311.6 million as of Dec. 31, 2025 , for a decrease of $25.1 million due primarily to operating activities offset by $14.0 million received from stock option exercises. Collaboration revenue was $25.6 million for the three months ended March 31, 2026 , compared to $27.8 million for the three months ended March 31, 2025 . The decrease in revenue was primarily due to $9.7 million in revenue recognized for the Vanda license agreement for the three months ended March 31, 2025 offset by Jemperli royalties increasing 44% from $17.2 million to $24.7 million for the three months ended March 31, 2026 . Research and development expenses were $34.0 million for the three ended March 31, 2026 , compared to $41.2 million for the three months ended March 31, 2025 . The decrease for the three months ended March 31, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the phase 1 trials for ANB033. The R&D non-cash, stock-based compensation expense was $4.6 million for the three months ended March 31, 2026 as compared to $4.4 million in the same period in 2025. General and administrative expenses were $26.2 million for the three months ended March 31, 2026 , compared to $14.1 million for the three months ended March 31, 2025 . The increase was due primarily to legal costs for the separation of the company, ongoing GSK litigation and non-cash stock compensation costs incurred for our former Chief Financial Officer and former Chief Legal Officer. The G&A non-cash, stock-based compensation expense was $9.7 million for the three months ended March 31, 2026 as compared to $4.8 million in the same period in 2025. Net loss was $52.9 million for the three months ended March 31, 2026 , or a net loss per share of $1.84 , compared to a net loss of $39.3 million for the three months ended March 31, 2025 , or a net loss per share of $1.28 . About AnaptysBio Anaptys manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning the value of its royalties to shareholders. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to whether Anaptys is able to protect its financial collaborations; and its ability to return value to its shareholders. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to protect its financial collaborations and return value to its shareholders, the company’s ability to operate efficiently with a limited staff, and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. This press release also includes a reference to EBIT margin which is a measure not presented in accordance with generally accepted accounting principles in the United States of America (“GAAP”), which Anaptys believes provides important perspective with respect to operational profitability. Non-GAAP financial measures may exclude items that are significant in understanding and assessing Anaptys’ financial results, should not be considered in isolation or as an alternative to GAAP measures, and should be considered only as a supplement to, and not as superior to, GAAP measures. Anaptys cannot predict with certainty the magnitude or scope of certain items that would be included in the most directly comparable GAAP measure to EBIT margin for the relevant future periods, and such items may be significant. Due to these uncertainties, Anaptys cannot provide a quantitative reconciliation of EBIT margin to the most directly comparable GAAP financial measure without unreasonable effort. Investor Contact:Anaptys Investor Relationsinvestors@anaptysbio.com _______________________________________ Source: AnaptysBio, Inc.

高管变更财报突破性疗法临床3期临床1期

2026-05-06

·PRNewswire

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76% NEREUS™ (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUS™ BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026 Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026 WASHINGTON, May 6, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026. "Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation." Financial Highlights Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025. Fanapt® net product sales were $29.6 million, up 26% year-over-year. HETLIOZ® net product sales were $15.9 million, down 24% year-over-year. PONVORY® net product sales were $6.2 million, up 10% year-over-year. Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant). Key Commercial Highlights Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026. NEREUS™ is now commercially available nationwide through nereus.us, Vanda's innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUS™ represents a breakthrough in both science and patient access. Key Regulatory & Clinical Development Highlights BYSANTI™ (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027. The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected by the end of 2026. The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2. Corporate Highlight On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent. GAAP Financial Results Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025. 2026 Financial Guidance Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™ while maintaining prior ranges for Fanapt® and other products: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 6, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8051722. A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 8051722. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of imsidolimab for the treatment of GPP, and the related timeline for approval; Vanda's expectations with respect to its continued growth and ability to create value; Vanda's clinical development plans and expected timelines for BYSANTITM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, and VQW-765 in the treatment of adults with social anxiety disorder; and Vanda's expectations with respect to the strength of its business are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for imsidolimab by December 12, 2026; Vanda's ability to successfully execute the commercial launches of NEREUSTM for the prevention of vomiting induced by motion and BYSANTI™ for the treatments of bipolar I disorder and schizophrenia; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the clinical study for BYSANTITM for the treatment of MDD and receive results in in the first quarter of 2027; Vanda's ability to complete the Thetis study and receive results in 2026; and Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

临床3期上市批准财报高管变更

2026-05-04

·N1 Life

全球一周皮肤用药速览：斑秃申报、白癜风3期和银屑病新数据更新

过去一周，皮肤治疗领域的公开信息集中在免疫炎症疾病、脱发、白癜风和皮肤肿瘤方向。进展包括FDA申报和BLA审评节点，也包括2期、3期临床数据和一项因中期分析建议停止的后期研究。以下按事件梳理本周皮肤用药与相关研究进展。Bambusa Therapeutics：BBT001完成特应性皮炎1b/2a期患者入组 Bambusa Therapeutics发布消息称，公司已完成BBT001在中重度特应性皮炎患者中的随机、双盲、安慰剂对照1b/2a期研究入组。BBT001是Bambusa的临床阶段核心候选药物，是一种半衰期延长的双特异性抗体，同时靶向IL-4Rα和IL-31，面向特应性皮炎及其他2型炎症性皮肤病开发。公司新闻稿称，这项研究在新西兰和美国临床中心开展，患者按2:1随机分配至BBT001 450mg治疗组或安慰剂组，每2周给药一次，治疗4周。主要终点是安全性和耐受性，探索性疗效和生物标志物终点包括Eczema Area and Severity Index（EASI，湿疹面积和严重程度指数）变化、Peak Pruritus Numerical Rating Scale（PP-NRS，瘙痒峰值数值评分）变化和TARC相对基线变化。公司计划在2026年中公布顶线结果。这项研究目前能确认的是患者入组完成和结果公布时间表，尚不能判断BBT001在患者中的疗效。对特应性皮炎研发而言，BBT001的双靶向设计已经进入临床概念验证阶段，后续关键仍是安全性、瘙痒改善速度和EASI结果能否同时成立。Vanda Pharmaceuticals：imsidolimab治疗泛发性脓疱型银屑病3期研究发表 Vanda Pharmaceuticals发布消息称，imsidolimab治疗泛发性脓疱型银屑病（Generalized Pustular Psoriasis，GPP）的关键3期研究已发表于NEJM Evidence。公司称，这项3期研究结果已纳入imsidolimab治疗GPP的生物制品许可申请（BLA），FDA目标审评日期为2026年12月12日。 Imsidolimab是一种全人源化IgG4单克隆抗体，抑制IL-36受体信号。GPP是罕见、严重的银屑病类型，IL-36通路是这一疾病药物开发中的重要靶点。Vanda拥有该药物来自AnaptysBio的全球开发和商业化独家许可。本次公开节点主要是研究发表和BLA审评时间表，而不是新的完整临床数据披露。对GPP领域而言，下一步更直接的判断点是FDA审评结论，以及标签中对人群、给药和安全性的具体限定。AbbVie：upadacitinib重度斑秃sNDA提交FDA 美国皮肤科行业媒体Dermatology Times报道称，AbbVie已向FDA提交upadacitinib（Rinvoq）用于成人和青少年重度斑秃的补充新药申请（sNDA）。申报依据来自UP-AA 3期临床项目，该项目包括两项重复性关键研究，共纳入1399名12至63岁患者。 UP-AA项目采用24周双盲、安慰剂对照阶段，随后进入至52周的盲法延长期。患者接受upadacitinib 15mg、30mg或安慰剂每日一次。报道显示，24周时达到Severity of Alopecia Tool（SALT，斑秃严重程度工具）≤20的患者比例，在15mg组分别为45.2%和44.6%，30mg组分别为55.0%和54.3%，安慰剂组为1.5%和3.4%。完全头皮毛发再生（SALT=0）在24周时也达到预设排序次要终点，30mg组约为20.3%和22.5%，安慰剂组为0%和0.7%。安全性方面，报道称52周结果与upadacitinib既有安全性资料一致；同时，JAK抑制剂类别的严重感染、恶性肿瘤、主要不良心血管事件、血栓和死亡风险仍是用药评估的一部分。如果获批，upadacitinib将成为继baricitinib之后美国斑秃系统治疗中的又一个JAK抑制剂选择，但长期维持、停药后复发和与既有药物的相对疗效仍需要更多资料。Soligenix：HyBryte™治疗皮肤T细胞淋巴瘤的FLASH2研究建议因无效停止 PR Newswire转发的Soligenix消息称，数据监查委员会完成了HyBryte™治疗皮肤T细胞淋巴瘤（CTCL）的关键3期FLASH2研究中期疗效分析，并建议该研究因无效停止。HyBryte™的研究名为SGX301，活性成分为合成金丝桃素，是一种局部应用后通过可见光激活的光动力治疗方案。公司称，早先发表的FLASH 3期研究在第一轮双盲治疗周期中显示，接受HyBryte™治疗的患者中16%达到病灶至少50%减少，安慰剂组为4%。但在FLASH2研究中，18周连续治疗未观察到类似疗效表现。公司表示将继续分析数据，并评估是否存在可能受益的特定患者亚组，以及是否与EMA和FDA进行后续讨论。这类中期无效停止对罕见皮肤肿瘤研发尤其重要：既往阳性研究、孤儿药资格和快速通道资格都不能替代第二项确认性研究。当前能确认的是FLASH2不支持按原计划继续推进，后续是否还有开发路径取决于完整数据分析和监管沟通结果。AbbVie：REACH-AD公布中国中重度特应性皮炎真实世界6个月中期结果美通社中文网发布的AbbVie消息称，公司在2026年美国皮肤病学会年会（AAD 2026）公布了REACH-AD研究中期结果。REACH-AD是一项正在进行中的前瞻性、多中心观察性研究，计划在中国40家中心纳入1000名中重度特应性皮炎患者，评估upadacitinib在真实临床实践中的治疗模式和最小疾病活动度达标情况。本次6个月中期分析包含504名患者，其中包括89名青少年。公司新闻稿称，6个月时，90.7%的患者达到EASI75或EASI评分≤7，71.7%的患者达到EASI90或EASI评分≤3，73.9%的患者达到PP-NRS改善≥4，51.1%的患者达到PP-NRS 0/1。复合指标方面，39.4%的患者达到最小疾病活动度，即EASI90或≤3并且PP-NRS 0/1。安全性方面，AbbVie称结果与已知资料一致，未发现新的安全性信号。这项研究补充的是中国真实临床实践中的使用和达标资料，而不是新的随机对照疗效比较。对于已进入临床使用的系统性AD治疗，真实世界中能否维持治疗、能否达到较高皮损和瘙痒目标，会直接影响医生和患者对治疗目标的理解。Veradermics：缓释口服minoxidil男性AGA 2/3期研究达到共同主要终点 Dermatology Times报道称，Veradermics公布VDPHL01在男性雄激素性脱发（androgenetic alopecia，AGA）中的2/3期Study 302 Part A顶线结果。VDPHL01是一种缓释口服minoxidil片剂，研究纳入519名轻中度AGA成年男性，随机接受8.5mg每日一次、8.5mg每日两次或安慰剂。报道显示，该研究在第6个月达到两个共同主要终点：非毳毛目标区域毛发计数（non-vellus Target Area Hair Count，TAHC）和患者报告的Androgenetic Alopecia Impact Rating Scale（AAIRS，雄激素性脱发影响评分）改善。每日一次和每日两次组的非毳毛TAHC平均分别增加30.3根/cm²和33.0根/cm²，安慰剂组为7.3根/cm²；AAIRS中报告任何改善的患者比例分别为79.3%和86.0%，安慰剂组为35.6%。安全性方面，报道称未观察到治疗相关严重不良事件，也未观察到心脏来源的特别关注不良事件。缓释制剂的开发逻辑是降低峰浓度并延长暴露时间，但该药物仍处于开发阶段；第二项男性3期研究预计2026年下半年公布结果，女性AGA研究仍在入组。Oruka Therapeutics：ORKA-001斑块状银屑病2a期16周数据公布美国生物医药媒体BioPharma Dive报道称，Oruka Therapeutics公布ORKA-001在中重度斑块状银屑病2a期EVERLAST-A研究中的16周数据。ORKA-001是一种靶向IL-23的单克隆抗体，开发方向是在维持较长给药间隔的同时，达到与现有银屑病生物制剂相近或更高的疗效。报道显示，63名接受ORKA-001治疗的患者中有40人在16周达到PASI100，即皮损完全清除；21名安慰剂患者中有1人达到这一结果。另有83%的ORKA-001治疗患者达到PASI90。安全性方面，接受ORKA-001的患者中未报告严重治疗期间不良事件，最常见不良事件为上呼吸道感染，发生率为19%。这是一项中期阶段研究，且没有与已上市IL-23或IL-17药物直接头对头比较。Oruka还提到另一项早期研究提示一年一次给药的可能性，但要判断这种长效设定能否真正改变银屑病治疗选择，还需要更长随访和后续2期研究结果。Incyte：povorcitinib非节段型白癜风两项3期研究达到主要终点 Fierce Biotech报道称，Incyte的口服JAK抑制剂povorcitinib在非节段型白癜风成人患者中完成两项3期研究STOP-V1和STOP-V2，30mg剂量均达到主要终点。主要终点为52周时面部白癜风评分改善超过75%。报道援引Incyte一季度业绩材料称，两项研究中，18.9%的povorcitinib治疗患者达到这一终点；对应安慰剂组比例分别为6.8%和3.1%。公司还称，关键次要终点也显示统计学显著且具有临床意义的差异，包括全身白癜风面积评分改善50%或以上。安全性和耐受性与既往研究一致，未观察到新的安全性信号。 Incyte计划用这些3期资料支持白癜风适应症注册申请，时间安排在2027年上半年。白癜风已获批系统治疗选择仍有限，povorcitinib的后续判断需要同时看注册路径、JAK类别安全性管理和与其他系统性JAK方案的疗效差异。本周观察本周的信息可以分为三类：upadacitinib斑秃和imsidolimab GPP进入注册审评节点；ORKA-001、povorcitinib和缓释口服minoxidil提供新的中后期临床结果；BBT001、REACH-AD和HyBryte™分别代表早期概念验证、真实世界使用资料和后期开发风险。对临床和研发判断来说，申报进度、随机对照结果、真实世界观察和中期停试不能混在同一层级解读。每一类资料都在补充皮肤用药图谱，但能支持的结论不同。关于N1 Life N1 Life, Inc.是一家总部位于美国硅谷、在中国苏州设有研发运营中心的生物科技公司，由斯坦福大学化学博士臧晓羽（Janice Zang）联合创立，核心技术孵化自斯坦福大学Wender实验室。公司拥有AbsoTide™（渗透增强）、MetaTide™（稳定靶向控释）、OmniTide™（大分子递送）三大精准递送引擎，持有多项国际专利（含PCT申请），并已完成FDA DMF及INCI注册认证。N1 Life与国际顶尖美妆及药妆品牌建立了深度合作生态，致力于将斯坦福前沿科学转化为下一代高效护肤与经皮给药解决方案。欲了解更多信息，请访问www.n1life.co参考资料 PR Newswire：Bambusa Therapeutics Completes Patient Enrollment in the Phase 1b/2a Trial Evaluating BBT001 as a Treatment for Atopic Dermatitis。https://www.prnewswire.com/news-releases/bambusa-therapeutics-completes-patient-enrollment-in-the-phase-1b2a-trial-evaluating-bbt001-as-a-treatment-for-atopic-dermatitis-302757932.html PR Newswire：Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence。https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-publication-of-efficacy-and-safety-of-imsidolimab-for-generalized-pustular-psoriasis-in-nejm-evidence-302756392.html Dermatology Times：AbbVie Submits sNDA for Upadacitinib in Adults and Adolescents With Severe Alopecia Areata。https://www.dermatologytimes.com/view/abbvie-submits-snda-for-upadacitinib-in-adults-and-adolescents-with-severe-alopecia-areata PR Newswire：Soligenix Announces Interim Results from the Phase 3 FLASH2 Trial Evaluating HyBryte™ in Treatment of Cutaneous T-Cell Lymphoma。https://www.prnewswire.com/news-releases/soligenix-announces-interim-results-from-the-phase-3-flash2-trial-evaluating-hybryte-in-treatment-of-cutaneous-t-cell-lymphoma-302754503.html 美通社中文网：艾伯维在2026年美国皮肤病学会年会上公布中国首个乌帕替尼治疗特应性皮炎的大规模真实世界队列研究REACH-AD的中期分析。https://www.prnasia.com/story/531004-1.shtml Dermatology Times：Phase 2/3 Trial of Extended-Release Oral Minoxidil Shows Robust Hair Growth Outcomes in Male Pattern Hair Loss。https://www.dermatologytimes.com/view/phase-2-3-trial-of-extended-release-oral-minoxidil-shows-robust-hair-growth-outcomes-in-male-pattern-hair-loss BioPharma Dive：Oruka surges as long-acting psoriasis drug shows early promise。https://www.biopharmadive.com/news/oruka-plaque-psoriasis-drug-study-results/818527/ Fierce Biotech：Incyte’s JAK inhibitor scores phase 3 vitiligo wins but can’t quite shake off Rinvoq。https://www.fiercebiotech.com/biotech/incytes-jak-inhibitor-scores-phase-3-vitiligo-wins-cant-quite-shake-rinvoq 免责声明：本文仅用于信息交流与科普参考。文中观点不代表N1 Life官方立场，也不构成任何诊断、治疗方案推荐或医疗建议。如需诊疗或健康管理指导，请前往正规医疗机构就诊，并遵循专业医师意见。版权说明：欢迎个人转发至朋友圈。未经授权，谢绝媒体、机构或其他平台转载、摘编、改写或二次发布本文内容。如需转载授权，请在N1 Life微信公众号后台回复「转载」，获取转载须知。

临床3期临床2期临床结果

100 项与 Imsidolimab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
泛发性脓疱型银屑病	申请上市	美国	Vanda Pharmaceuticals, Inc.	2025-12-17
化脓性汗腺炎	临床2期	美国	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	加拿大	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	加拿大	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	格鲁吉亚	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	波兰	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	波兰	AnaptysBio, Inc.	2021-07-07
寻常痤疮	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-05-15
寻常痤疮	临床2期	加拿大	Vanda Pharmaceuticals, Inc.	2021-05-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05366855 (GEMINI-2, CTgov)	临床3期	泛发性脓疱型银屑病	42	imsidol (ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC)	艱膚窪糧淵鏇顧夢鹽夢 = 餘製鹽築鑰壓範範構網鹹築憲糧衊鬱遞製窪衊 (積糧鑰壓夢壓顧廠鏇繭, 鑰網遞壓觸製製淵餘獵 ~ 觸築觸鑰願繭製積遞築) 更多	-	2026-03-27
				Placebo (ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC)	艱膚窪糧淵鏇顧夢鹽夢 = 積選範鬱遞觸鹹築範襯鹹築憲糧衊鬱遞製窪衊 (積糧鑰壓夢壓顧廠鏇繭, 鏇願蓋鑰鹹選廠範鬱遞 ~ 壓糧選積鏇糧遞衊願淵) 更多
NCT05352893 (GEMINI1 \| GEMINI-1, CTgov)	临床3期	泛发性脓疱型银屑病	45	Placebo	壓糧網鹹憲鹹顧積範蓋 = 憲艱網膚網遞願鹹鑰繭構繭鏇餘蓋簾膚顧蓋膚 (簾壓鏇鹹製構齋艱顧選, 齋襯製鹽選齋艱範築餘 ~ 積築繭夢網鬱襯遞蓋簾) 更多	-	2026-03-17
NCT04856930 (CTgov)	临床2期	化脓性汗腺炎	149	Imsidolimab (Placebo-Controlled Period: Imsidolimab 400/200 mg)	鑰獵廠襯糧鏇襯糧願夢(鹽鑰醖觸廠襯憲壓夢夢) = 鏇艱淵鑰範顧糧鬱夢繭餘鏇簾齋簾獵淵構願遞 (糧鹽餘淵繭艱鹽淵遞憲, 6.05) 更多	-	2025-09-22
				Imsidolimab (Placebo-Controlled Period: Imsidolimab 200/100 mg)	鑰獵廠襯糧鏇襯糧願夢(鹽鑰醖觸廠襯憲壓夢夢) = 繭醖願鏇築繭顧壓衊膚餘鏇簾齋簾獵淵構願遞 (糧鹽餘淵繭艱鹽淵遞憲, 4.63) 更多
NCT05352893 (GEMINI1, GlobeNewswire) 人工标引	临床3期	泛发性脓疱型银屑病	45	Imsidolimab 750mg (GEMINI-1)	窪願齋構淵顧製壓膚鹽(衊遞積襯觸顧餘鹽糧選) = 鹹衊網夢蓋鑰衊膚淵廠積遞網獵夢淵觸顧憲醖 (製顧醖獵獵淵膚製襯鹹 )	积极	2024-05-09
				Imsidolimab 300mg (GEMINI-1)	窪願齋構淵顧製壓膚鹽(衊遞積襯觸顧餘鹽糧選) = 廠淵壓艱糧窪獵糧餘鏇積遞網獵夢淵觸顧憲醖 (製顧醖獵獵淵膚製襯鹹 )
NCT05366855 (GEMINI-2, GlobeNewswire) 人工标引	临床3期	泛发性脓疱型银屑病维持	16	imsidolimab (GEMINI-2 + GPPPGA 0/1 responder patients from GEMINI-1)	壓顧繭糧顧遞選積窪觸(艱夢窪鏇繭襯淵構醖構) = 積鏇鹽顧蓋夢廠鹹憲鏇鏇膚顧製製獵淵壓廠鹹 (簾鹹襯窪窪獵醖鬱簾觸 )	积极	2024-05-09
NCT05352893 (GEMINI1, Corporate Publications) 人工标引	临床3期	泛发性脓疱型银屑病	45	Imsidolimab	願積壓鹹構築蓋鹹醖顧(築膚鏇鬱選夢壓齋網夢) = 網築齋齋繭遞網網顧衊夢築齋淵鑰遞壓鏇鏇觸 (網鏇顧簾夢壓簾遞繭範 ) 达到更多	积极	2023-10-09
				Placebo	願積壓鹹構築蓋鹹醖顧(築膚鏇鬱選夢壓齋網夢) = 膚遞淵築夢觸憲膚願餘夢築齋淵鑰遞壓鏇鏇觸 (網鏇顧簾夢壓簾遞繭範 ) 达到
NCT04856917 (CTgov)	临床2期	寻常痤疮	123	Imsidolimab (Imsidolimab 400/200 mg)	醖選構選壓膚顧獵簾網(網網選鬱鑰襯獵遞壓蓋) = 網鬱廠鹹蓋構範膚構顧積襯夢襯齋窪膚窪網範 (獵築膚艱觸淵淵網夢醖, 13.63) 更多	-	2023-06-15
				Imsidolimab (Imsidolimab 200/100 mg)	醖選構選壓膚顧獵簾網(網網選鬱鑰襯獵遞壓蓋) = 鹹壓範製醖窪憲艱遞顧積襯夢襯齋窪膚窪網範 (獵築膚艱觸淵淵網夢醖, 16.38) 更多
NCT04697056 (CTgov)	临床2期	鱼鳞病	5	Imsidolimab (Imsidolimab)	夢範鏇齋顧糧齋願廠築 = 構遞願廠積壓夢鬱壓淵齋顧淵築鏇繭願簾鑰淵 (鹹鹹鬱蓋鏇艱簾餘膚構, 願衊鹽築構憲壓網簾餘 ~ 範淵淵淵鹽醖觸觸鏇齋) 更多	-	2023-03-02
				placebo (Placebo)	夢範鏇齋顧糧齋願廠築 = 壓鏇壓鏇蓋膚構鏇選願齋顧淵築鏇繭願簾鑰淵 (鹹鹹鬱蓋鏇艱簾餘膚構, 願願繭蓋憲製醖簾獵艱 ~ 蓋蓋簾網蓋鬱鹹廠糧簾) 更多
NCT03633396 (POPLAR, CTgov)	临床2期	手掌和足底脓疱病	59	Placebo (Placebo)	廠網鑰鏇範衊構齋築醖(淵襯衊獵衊鏇壓遞網觸) = 構糧顧網鏇鏇選衊鹽蓋獵簾衊憲餘夢選鏇鬱積 (艱糧製鹽遞淵觸窪鹽網, 1.48) 更多	-	2022-05-31
				Imsidolimab (Imsidolimab)	廠網鑰鏇範衊構齋築醖(淵襯衊獵衊鏇壓遞網觸) = 簾餘鏇簾壓壓襯齋壓憲獵簾衊憲餘夢選鏇鬱積 (艱糧製鹽遞淵觸窪鹽網, 1.46) 更多
NCT03633396 (POPLAR, GlobeNewswire) 人工标引	临床2期	银屑病	-	Imsidolimab	鑰觸襯窪醖憲艱積獵壓(構醖網積遞膚醖衊獵觸) = 餘膚壓餘醖艱夢築餘鏇鑰遞簾壓艱艱糧範繭餘 (顧築膚窪鹹範遞艱艱廠 ) 更多	不佳	2021-03-08
				Placebo	鑰觸襯窪醖憲艱積獵壓(構醖網積遞膚醖衊獵觸) = 憲艱選製簾膚簾壓醖鑰鑰遞簾壓艱艱糧範繭餘 (顧築膚窪鹹範遞艱艱廠 ) 更多