An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

开始日期2024-09-03

申办/合作机构

Gossamer Bio, Inc.

JPRN-jRCT2051230191

/ Recruiting临床3期IIT

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

开始日期2024-04-01

申办/合作机构-

NCT05934526

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

开始日期2023-12-28

申办/合作机构

Gossamer Bio, Inc.

100 项与 Seralutinib 相关的临床结果

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100 项与 Seralutinib 相关的转化医学

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100 项与 Seralutinib 相关的专利（医药）

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项与 Seralutinib 相关的文献（医药）

2025-02-01·Clinical Pharmacology in Drug Development

Phase 1 Studies to Assess Inhaled Seralutinib as a Perpetrator or a Victim of Drug‐Drug Interactions in Healthy Participants

Article

作者: Cravets, Matt ; DeNoia, Emanuel ; Key, Cassandra ; Mathias, Anita ; Parsley, Ed ; Li, Jianke

Abstract:

Seralutinib, an inhaled, small‐molecule tyrosine kinase inhibitor in clinical development for the treatment of pulmonary arterial hypertension (PAH), was evaluated for its potential as a perpetrator or victim of a metabolic and transporter‐based drug‐drug interactions in 2 phase 1 studies. In study 1, 24 participants received a cocktail of probe substrates: caffeine (CYP1A2), montelukast (CYP2C8), flurbiprofen (CYP2C9), midazolam (CYP3A), and pravastatin (OATP1B1/1B3), plus digoxin (P‐gp) with or without seralutinib. In study 2, 19 participants received seralutinib with/without itraconazole, a strong CYP3A inhibitor, or fosaprepitant, a weak CYP3A inhibitor. Geometric least‐squares mean ratios and 90% confidence intervals for maximum observed concentration (Cmax) and area under the plasma concentration‐time curve (AUC) were obtained. Safety was monitored throughout the studies. All adverse events were mild or moderate in severity. Seralutinib coadministration increased AUC for midazolam 3.03‐fold and caffeine 1.32‐fold. The coadministration increased digoxin Cmax 1.28‐fold. Seralutinib did not meaningfully alter Cmax and AUC for montelukast, flurbiprofen, or pravastatin. Fosaprepitant and itraconazole increased seralutinib AUC 1.08‐ and 1.84‐fold, respectively. Seralutinib is a moderate CYP3A inhibitor and a weak CYP1A2 inhibitor; it slightly inhibits P‐gp. Seralutinib exposure is minimally affected by a weak CYP3A inhibitor but is substantially increased by a strong CYP3A inhibitor.

2024-07-01·Lancet Respiratory Medicine

Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

Article

作者: Opitz, Christian ; Channick, Richard N ; Sood, Namita ; Hirani, Naushad ; Benza, Raymond L ; Chakinala, Murali M. ; Frantz, Robert P ; Elman, Erin ; Cravets, Matt ; Sitbon, Olivier ; Stevens, Wendy ; Fisher, Micah ; Delcroix, Marion ; Robinson, Jeffrey ; Parsley, Ed ; Ghofrani, Hossein-Ardeschir ; Sobol, Irina R. ; Ryan, John ; Highland, Kristin ; Aranda, Richard ; Grünig, Ekkehard ; Spikes, Leslie A. ; Melendres-Groves, Lana ; Sager, Jeffrey ; Zolty, Ronald L ; Rahaghi, Franck ; Sulica, Roxana ; Jansa, Pavel ; Raina, Amresh ; Raviv, Yael ; Baillie, Timothy ; Lopez-Meseguer, Manuel ; Keogh, Anne ; Mehta, Sanjay ; McConnell, John W. ; Escribano Subías, Pilar ; Pillutla, Priya ; Franco, Veronica ; Stadler, Stefan ; Hemnes, Anna R ; Chin, Kelly M ; Bruey, Jean-Marie ; Dwyer, Nathan ; Sahay, Sandeep ; Cifrián Martínez, Jose Manual ; Roscigno, Robert F ; Kingrey, John ; White, R. James ; Hill, Nicholas ; Vachiéry, Jean-Luc ; Mottola, David ; Pepke-Zaba, Joanna ; Howard, Luke S ; Shapiro, Shelley ; Smith, Kerri ; Hoeper, Marius ; Osterhout, Robin ; Elwing, Jean M. ; Adir, Yochai ; Tompkins, Cindy-ann ; Simon, Marc ; McLaughlin, Vallerie V ; Burger, Charles ; Baratz, David ; Zisman, Lawrence S ; Zamanian, Roham T

BACKGROUND:

Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1 receptor, and mast or stem cell growth factor receptor kinases stimulates inflammatory, proliferative, and fibrotic pathways driving pulmonary vascular remodelling in PAH. Seralutinib, an inhaled kinase inhibitor, targets these pathways. We aimed to evaluate the efficacy and safety of seralutinib in patients with PAH receiving standard background therapy.

METHODS:

The TORREY trial was a phase 2, randomised, multicentre, multinational, double-blind, placebo-controlled study. Patients with PAH from 40 hospital and community sites were randomly assigned 1:1 via interactive response technologies to receive seralutinib (60 mg twice daily for 2 weeks, then increased to 90 mg twice daily as tolerated) or placebo by dry powder inhaler twice daily for 24 weeks. Randomisation was stratified by baseline pulmonary vascular resistance (PVR; <800 dyne·s/cm⁵ and ≥800 dyne·s/cm⁵). Patients were eligible if classified as WHO Group 1 PH (PAH), WHO Functional Class II or III, with a PVR of 400 dyne·s/cm⁵ or more, and a 6 min walk distance of between 150 m and 550 m. The primary endpoint was change in PVR from baseline to 24 weeks. Analyses for efficacy endpoints were conducted in randomly assigned patients (intention-to-treat population). Safety analyses included all patients who received the study drug. TORREY was registered with ClinicalTrials.gov (NCT04456998) and EudraCT (2019-002669-37) and is completed.

FINDINGS:

From Nov 12, 2020, to April 20, 2022, 151 patients were screened for eligibility, and following exclusions, 86 adults receiving PAH background therapy were randomly assigned to seralutinib (n=44; four male, 40 female) or placebo (n=42; four male, 38 female), and comprised the intention-to-treat population. At baseline, treatment groups were balanced except for a higher representation of WHO Functional Class II patients in the seralutinib group. The least squares mean change from baseline to week 24 in PVR was 21·2 dyne·s/cm⁵ (95% CI -37·4 to 79·8) for the placebo group and -74·9 dyne·s/cm⁵ (-139·7 to -10·2) for the seralutinib group. The least squares mean difference between the seralutinib and placebo groups for change in PVR was -96·1 dyne·s/cm⁵ (95% CI -183·5 to -8·8; p=0·03). The most common treatment-emergent adverse event in both treatment groups was cough: 16 (38%) of 42 patients in the placebo group; 19 (43%) of 44 patients in the seralutinib group.

INTERPRETATION:

Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background therapy for PAH.

FUNDING:

Gossamer Bio.

2024-01-01·ERJ open research

ERS International Congress 2023: highlights from the Pulmonary Vascular Diseases Assembly

Article

作者: Lichtblau, Mona ; Genecand, Leon ; Park, Da-Hee ; Sitbon, Olivier ; Jutant, Etienne-Marie ; Lechartier, Benoit ; Bertoletti, Laurent ; Bokan, Aleksandar ; Boucly, Athénaïs ; Piccari, Lucilla ; Guiot, Julien ; Ulrich, Silvia ; Vonk-Noordegraaf, Anton ; Cullivan, Sarah ; Jevnikar, Mitja

Pulmonary vascular diseases such as pulmonary embolism and pulmonary hypertension are important and frequently under-recognised conditions. This article provides an overview of key highlights in pulmonary vascular diseases from the European Respiratory Society International Congress 2023. This includes insights into disease modification in pulmonary arterial hypertension and novel therapies such as sotatercept and seralutinib. Exciting developments in our understanding of the mechanisms underpinning pulmonary hypertension associated with interstitial lung disease are also explored. A comprehensive overview of the complex relationship between acute pulmonary embolism and chronic thromboembolic pulmonary hypertension (CTEPH) is provided along with our current understanding of the molecular determinants of CTEPH. The importance of multidisciplinary and holistic care cannot be understated, and this article also addresses advances beyond medication, with a special focus on exercise training and rehabilitation.

项与 Seralutinib 相关的新闻（医药）

2025-01-28

·Business Wire

Gossamer Bio to Present Clinical and Preclinical Data at the Pulmonary Vascular Research Institute 2025 Annual Congress

SAN DIEGO--( BUSINESS WIRE )-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced one oral and three poster presentations related to seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress taking place January 29 th through February 1 st in Rio de Janeiro, Brazil. “Gossamer is committed to generating and presenting data that reflect the rapidly evolving pulmonary hypertension treatment landscape to best address the needs of patients. To that end, we are immensely proud to be able to present data from preclinical models that provide evidence of a synergistic treatment effect from the combination of seralutinib and sotatercept, a recently approved therapy for the treatment of PAH,” said Faheem Hasnain, Co-Founder, CEO, and Chairman of Gossamer Bio. “These data underscore seralutinib’s potential to transform the PAH treatment paradigm, if approved, and they highlight the potential promise of these complementary mechanisms of action when utilized in combination. PAH is a progressive disease in which polypharmacy is the standard of care, and these preclinical results further build upon the positive PAH patient data generated in the Phase 2 TORREY Study, in which a majority of patients were on triple background PAH therapy.” “Furthermore, our ongoing global registrational Phase 3 PROSERA Study in PAH allows for the enrollment of a small number of patients on stable background treatment with sotatercept, provided they meet study entry criteria. All other patients who are enrolled in PROSERA may add sotatercept after 24 weeks, where approved and as appropriate. These study design elements will provide a limited, first-in-human combination experience with seralutinib and sotatercept, and importantly, they have been welcomed by patients and investigators, alike,” added Mr. Hasnain. Presentations related to Seralutinib, an Inhaled PDGFR, CSF1R and c-KIT Inhibitor: Preclinical Models Support the Synergistic Potential of Seralutinib and Sotatercept in Treating Pulmonary Arterial Hypertension Oral presentation Session: Risk stratification & treatment in the new era of PH therapeutics Date: Thursday, January 30 th Time: 3:07pm – 3:15pm BRT Location: Windsor Oceanico, Asia, 3 rd floor Presenter: Ravikumar Sitapara, MS, PhD Poster presentation Date: Friday, January 31 st Time: 4:30pm – 6:00pm BRT Location: Windsor Oceanico, Asia, 3 rd floor Sustained Benefit with Seralutinib Treatment: A Post-Hoc Analysis of the TORREY Open-Label Extension Poster presentation Date: Friday, January 31 st Time: 4:30pm – 6:00pm BRT Location: Windsor Oceanico, Asia, 3 rd floor Sustained Effect of Seralutinib on Circulating Biomarkers in the TORREY Phase 2 Open-Label Extension Study Poster presentation Date: Friday, January 31 st Time: 4:30pm – 6:00pm BRT Location: Windsor Oceanico, Asia, 3 rd floor About Gossamer Bio Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the ability to generate relevant seralutinib clinical data for the evolving PAH treatment landscape and the development and market potential of seralutinib. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer’s business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from a pandemic, including clinical trial delays; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer’s clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer’s ability to obtain and maintain intellectual property protection for seralutinib; Gossamer’s ability to comply with its obligations in collaboration agreements with third parties, including Chiesi, or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

临床2期临床3期

2024-12-03

·GlobeNewswire-Health Care

XOMA Royalty Acquires Pulmokine for $20 Million Adding the Royalty and Milestone Interest in Seralutinib, a Phase 3 Asset, to Its Portfolio

Seralutinib becomes XOMA Royalty’s seventh Phase 3 royalty asset, further building the late-stage pipeline beyond its six current commercial royalty assets Seralutinib is being developed and co-commercialized by Gossamer Bio, Inc., and Chiesi Farmaceutici S.p.A; a Phase 3 study for pulmonary arterial hypertension is ongoing and is expected to read out in the fourth quarter of 20251 XOMA Royalty has the potential to net up to $25 million in milestone payments and earn a low to mid-single digit royalty Dec. 02, 2024 -- XOMA Royalty Corporation (NASDAQ: XOMA) announced today it now owns an economic interest in seralutinib, a Phase 3 asset being studied in pulmonary arterial hypertension (PAH), through its acquisition of Pulmokine Inc., a privately held company. In 2017, Pulmokine licensed seralutinib to Gossamer Bio, Inc., and in 2024, Gossamer Bio signed a global collaboration and license agreement with Chiesi Farmaceutici S.p.A. “We acquired Pulmokine to add seralutinib, a Phase 3 asset with strong mechanistic rationale in PAH, to our growing royalty and milestone portfolio while creating a favorable outcome for Pulmokine’s founders and stockholders. In addition, we believe seralutinib has the potential to address several cardio-respiratory conditions beyond PAH in the future,” stated Brad Sitko, Chief Investment Officer of XOMA Royalty. “This transaction marks the second whole-company acquisition we have completed in 2024. We continue to offer creative royalty capital solutions to access assets with the potential to deliver attractive returns to XOMA Royalty’s diverse portfolio.” XOMA Royalty acquired all outstanding shares of Pulmokine for a $20 million cash payment at closing. In addition, XOMA Royalty will pay success-based consideration contingent on future development and commercial events to Pulmokine stockholders. XOMA Royalty’s net royalties will range from the low to mid-single digits on commercial sales; additionally, the Company will retain up to $25 million of the milestone payments. XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about XOMA Royalty and its portfolio, please visit www.xoma.com or follow the Company on LinkedIn. 1 https://ir.gossamerbio.com/news-releases/news-release-details/gossamer-bio-announces-third-quarter-2024-financial-results-and The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出并购

2024-12-02

·Endpoints

Senti Bio’s Phase 1 CAR-NK data; Allink raises $42M

Plus, news about Cytokinetics, Theratechnologies, KisoJi Biotechnology and XOMA Royalty: Senti Bio touts early Phase 1 CAR-NK data, stock soars: Two of three patients who received the low dose of Senti’s treatment achieved a complete response as of the Sept. 19 data cutoff. Senti expects to enroll 20 patients in the study. Its stock rose more than 150% in premarket trading on Monday, and the company also said it secured a $37.6 million PIPE. — Max Gelman China startup nabs $42M Series A: Allink Biotherapeutics, which was founded in 2023, is focused on bispecifics and antibody-drug conjugates. The money will help fund two pipeline programs called ALK201 and ALK202 through Phase 1 trials, as well as push forward other efforts in oncology and immunology. The round was led by Lanchi Ventures. — Max Gelman Cytokinetics’ heart drug gets FDA decision date: The biotech announced that the FDA has set a deadline of Sept. 26 to decide whether to approve aficamten for a heart condition called obstructive hypertrophic cardiomyopathy. The agency currently has no plans to hold an advisory committee. If approved, the treatment would compete with Bristol Myers Squibb’s Camzyos, which is currently the only cardiac myosin inhibitor approved in the US. — Lei Lei Wu Theratechnologies reveals financing: The Montreal biotech said it could get up to $75 million from TD Bank and Investissement Québec via credit facilities. Some of the loans will go toward paying off existing credit facilities and bankroll business development. The company had about $20 million in cash at the end of November. — Kyle LaHucik KisoJi gets $41M to advance TROP2 program: The company plans to use the money to get KJ-103, its lead compound, into Phase 1 testing for solid tumors. Funds include “the conversion of previously funded convertible debentures.” Investissement Québec and Lumira Ventures led the financing. — Max Gelman XOMA’s latest royalty deal: The royalty company bought Pulmokine for $20 million in cash. The move gives XOMA access to a milestone and royalty stream from Pulmokine’s interest in seralutinib, the pulmonary arterial hypertension drug it licensed to Gossamer Bio. The drug is now in Phase 3, with a readout slated for late 2025. — Kyle LaHucik

临床1期临床3期上市批准抗体药物偶联物

100 项与 Seralutinib 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
家族性肺动脉高压	临床3期	美国	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	日本	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	阿根廷	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	澳大利亚	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	奥地利	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	比利时	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	巴西	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	加拿大	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	智利	Gossamer Bio, Inc.	2023-12-28
家族性肺动脉高压	临床3期	哥伦比亚	Gossamer Bio, Inc.	2023-12-28

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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


NCT04816604 (ATS2024) 人工标引	临床2期	肺动脉高压	74	seralutinib-to-seralutinib	網遞夢齋願觸糧淵鹽餘(糧艱淵獵鑰願糧鏇淵觸) = Most common TEAEs were headache (24.3%), COVID-19 (21.6%), and cough (21.6%). 網繭鏇艱築鹽醖鑰鹹簾 (鹹網淵鬱蓋遞積蓋蓋襯 ) 更多	积极	2024-05-19
				placebo-to-seralutinib
NCT04456998 (TORREY, CTgov)	临床2期	肺动脉高压	86	Placebo (Placebo)	壓網鹽鏇窪壓鬱製艱遞(壓壓蓋廠餘鏇顧選襯襯) = 願網憲觸壓網鑰淵淵鬱遞鬱範廠襯獵鏇網構獵 (壓醖積鬱壓糧構顧築願, 選鏇餘膚膚獵遞積觸膚 ~ 選憲衊範齋顧夢顧鏇襯) 更多	-	2023-11-07
				Generic Dry Powder Inhaler+GB002 (seralutinib) (GB002 (Seralutinib))	壓網鹽鏇窪壓鬱製艱遞(壓壓蓋廠餘鏇顧選襯襯) = 選構願廠鏇鏇選鑰廠簾遞鬱範廠襯獵鏇網構獵 (壓醖積鬱壓糧構顧築願, 鹹膚製艱鏇淵簾衊淵選 ~ 襯顧顧積鏇淵繭鹹願積) 更多
NCT04456998 (TORREY, Corporate Publications) 人工标引	临床2期	肺动脉高压	86	Seralutinib	艱觸積鹹蓋顧醖壓鏇夢(範餘蓋憲廠築窪衊製膚): P-Value = 0.0310 达到更多	积极	2022-12-06
				placebo
NCT03926793 (GB002, ERS2020)	临床1期	肺动脉高压 BMPR2 expression	-	GB002	構願窪鏇鏇鏇鏇餘構觸(膚衊衊襯願積鏇製夢鬱) = increased in a dose- and time- dependent manner 衊願觸窪構餘製築醖糧 (膚壓鹹鏇鏇夢範齋窪製 ) 更多	积极	2020-09-07