Pemvidutide

Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and investments as of June 30, 2026 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update. “We have achieved several important milestones as we continue to successfully execute our strategy, including the initiation of the PERFORMA Phase 3 MASH trial and positive topline data from the RECLAIM Phase 2 AUD trial. The team remains focused on advancing our differentiated pemvidutide franchise in both MASH and AUD, each an area of unmet need with substantial future sales potential,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “We are also pleased to announce completion of enrollment in the RESTORE Phase 2 ALD trial. Our momentum positions Altimmune to deliver on our goals of bringing pemvidutide to patients with serious liver diseases and creating value for shareholders.” Key Highlights and Anticipated Milestones Metabolic Dysfunction-Associated Steatohepatitis (MASH) Pemvidutide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on 24-week data from the IMPACT Phase 2b trial In August 2026 , the Company announced the initiation of the global PERFORMA Phase 3 MASH trial, with 52-week data readout anticipated in 2029 The PERFORMA trial is a Phase 3, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects with MASH Alcohol Use Disorder (AUD) In July 2026 , the Company reported positive topline results from the RECLAIM Phase 2 trial of pemvidutide in AUD The RECLAIM trial evaluated the safety and efficacy of pemvidutide versus placebo in 100 patients with AUD over a 24-week treatment period Pemvidutide achieved a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial Important secondary endpoints were also met, including a 2-level reduction in WHO-risk drinking levels and zero heavy drinking days, both recognized by the FDA as registrational endpoints A generally favorable safety and tolerability pro observed in the trial The Company plans to request an End-of-Phase 2 meeting with the FDA and engage with the European regulatory agencies to discuss a path forward in AUD The FDA granted Fast Track designation to pemvidutide for the treatment of AUD Alcohol-associated Liver Disease (ALD) In July 2026, the Company completed patient enrollment in the RESTORE Phase 2 trial of pemvidutide in ALD The RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 120 patients with liver disease due to excessive alcohol consumption The trial enrolled patients with ALD and a history of chronic and heavy drinking at baseline To support future regulatory discussions, the Company has amended the trial protocol to more fully evaluate the liver benefits pemvidutide may provide after one year of treatment in the ALD population The primary endpoint, change from baseline in Liver Stiffness Measurement (LSM), will now be assessed hierarchically at Week 48 and then at Week 24 The secondary endpoints include changes in Enhanced Liver Fibrosis (ELF) score, alcohol consumption and body weight The Company expects to report topline data in the second half of 2027 Corporate Updates In April 2026 , the Company completed an oversubscribed public offering of common stock, pre-funded warrants, and stock warrants, resulting in gross proceeds of $225.0 million In June 2026 , the Company announced plans to relocate its corporate headquarters to Morristown, New Jersey later in 2026 Financial Results for the Three Months Ended June 30, 2026 Altimmune reported cash, cash equivalents and investments totaling $519 million as of June 30, 2026 Research and development (R&D) expenses were $18.7 million for the three months ended June 30, 2026, compared to $17.2 million in the same period in 2025, with the increase driven primarily by the ongoing ALD trial as well as the startup costs for the PERFORMA Phase 3 trial in MASH, partially offset by the decrease in expenses related to completion of the IMPACT Phase 2b trial in MASH, which was ongoing in 2025. R&D expenses for the quarter ended June 30, 2026, included $11.6 million in direct costs related to pemvidutide development activities General and administrative (G&A) expenses were $7.6 million for the three months ended June 30, 2026, compared to $5.7 million in the same period in 2025. The increase was driven primarily by an increase in professional services and compensation expenses in the second quarter of 2026 Interest income was $4.5 million for the three months ended June 30, 2026 Net loss for the three months ended June 30, 2026, was $22.8 million, or $0.12 net loss per share, compared to a net loss of $22.1 million, or $0.27 net loss per share, in the same period in 2025 Conference Call Information: Date: August 12, 2026 Time: 8:30 a.m. Eastern Time Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations (IR) website at . Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call. Following the conclusion of the call, the webcast will be available for replay on the IR page of the Company’s website at . The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. About Pemvidutide Pemvidutide is an investigational novel peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity that has an effect on reducing liver fat, inflammation, and fibrosis, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss and are involved in pathways related to craving and reward. The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced topline 48-week data from the IMPACT Phase 2b trial in MASH. In July 2026, the PERFORMA Phase 3 trial, a global, randomized, double-blind, placebo-controlled, parallel-group study of pemvidutide in patients with MASH was initiated. In July 2026, the Company announced positive topline results from the RECLAIM Phase 2 trial in AUD. In July 2026, the Company completed enrollment of the RESTORE Phase 2 trial in ALD. About Altimmune Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit . Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on X Forward-Looking Statements Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing PERFORMA and RESTORE trials, the timing of key milestones for the Company’s clinical programs, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at . Investor Contact: Luis Sanay, CFA Vice President, Investor Relations ir@altimmune.com Media Contact: Real Chemistry altimmune@realchemistry.com ALTIMMUNE, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per-share amounts) June 30, December 31, 2026 2025 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 63,008 $ 43,760 Restricted cash 42 42 Total cash, cash equivalents and restricted cash 63,050 43,802 Short-term investments 263,273 229,696 Accounts and other receivables 3,341 1,219 Income tax and R&D incentive receivables — 518 Prepaid expenses and other current assets 5,151 2,957 Total current assets 334,815 278,192 Long-term investments 192,247 — Property and equipment, net 60 312 Other assets 90 1,425 Total assets $ 527,212 $ 279,929 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,272 $ 2,717 Accrued expenses and other current liabilities 11,229 12,280 Total current liabilities 12,501 14,997 Term loan, noncurrent 34,742 34,287 Other noncurrent liabilities 5,761 5,753 Total liabilities 53,004 55,037 Commitments and contingencies Stockholders’ equity: Common stock, $0.0001 par value; 400,000,000 and 200,000,000 shares authorized; 194,474,154 and 110,882,735 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 19 11 Additional paid-in capital 1,175,098 879,292 Accumulated deficit (694,871 ) (649,483 ) Accumulated other comprehensive loss, net (6,038 ) (4,928 ) Total stockholders’ equity 474,208 224,892 Total liabilities and stockholders’ equity $ 527,212 $ 279,929 ALTIMMUNE, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (In thousands, except share and per-share amounts) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Revenues $ — $ 5 $ — $ 10 Operating expenses: Research and development 18,655 17,236 34,847 33,063 General and administrative 7,574 5,691 15,626 11,684 Total operating expenses 26,229 22,927 50,473 44,747 Loss from operations (26,229 ) (22,922 ) (50,473 ) (44,737 ) Other income (expense): Interest expense (1,097 ) (264 ) (2,165 ) (265 ) Interest income 4,526 1,132 7,427 2,677 Other income (expense), net (25 ) (92 ) (177 ) (77 ) Total other income (expense), net 3,404 776 5,085 2,335 Net loss before income taxes (22,825 ) (22,146 ) (45,388 ) (42,402 ) Income tax expense (benefit) — — — (681 ) Net loss (22,825 ) (22,146 ) (45,388 ) (41,721 ) Other comprehensive income — unrealized loss on investments (814 ) (36 ) (1,110 ) (66 ) Comprehensive loss $ (23,639 ) $ (22,182 ) $ (46,498 ) $ (41,787 ) Net loss per share, basic and diluted $ (0.12 ) $ (0.27 ) $ (0.29 ) $ (0.53 ) Weighted-average common shares outstanding, basic and diluted 185,443,736 81,477,548 155,121,235 78,529,028

温馨提示 肽研社建读者交流群啦~ 行业交流、商务合作、报告咨询 请添加小编微信，后续入群哦👇 研究进展 01 歌礼制药 2026-08-03香港，歌礼制药（Ascletis Pharma，HX：1672）宣布，其每日一次口服小分子GLP-1受体激动剂ASC30已获得FDA III期临床许可，并正式启动全球III期临床项目。同时，公司公布了口服小分子GLP-1/GIP/胰淀素三重激动剂固定剂量复方的临床前数据，进一步完善其口服小分子减重药管线。 ASC30全球III期项目由两项关键性研究AURORA-1和AURORA-2组成，计划在美国、欧洲和加拿大招募约4,600名超重或肥胖受试者。其中，AURORA-1针对不伴2型糖尿病的超重或肥胖人群，AURORA-2针对合并2型糖尿病的人群。两项研究均采用随机、双盲、安慰剂对照设计，治疗周期为72周，评估20 mg、40 mg和60 mg三种维持剂量每日一次口服ASC30的长期减重疗效、安全性及耐受性。 公司预计于2028Q3公布ASC30全球III期主要数据，并计划于2028年底向FDA提交新药申请NDA，于2029年初向EMA提交MAA。若最终获批，ASC30有望成为继orforglipron之后第二款在美国和欧洲获批的口服小分子GLP-1药物。 除ASC30单药外，歌礼制药正在构建覆盖GLP-1、GIP和胰淀素通路的“一日一片”口服小分子组合产品矩阵。目前，公司共有5个相关项目，分别包括处于III期的GLP-1受体激动剂ASC30、计划于2026Q4申报IND的GLP-1/GIP双激动剂固定剂量复方ASC30_48FDC、同样计划于Q4申报IND的GLP-1/GIP/胰淀素三重激动剂ASC30_48_39FDC，以及预计于Q3申报IND的选择性胰淀素受体激动剂ASC39和GLP-1/胰淀素双激动剂固定剂量复方ASC30_39FDC。 在最新临床前研究中，ASC30_48_39FDC在食蟹猴等非人灵长类动物中展现出进一步减重潜力。连续给药7天后，加入不同剂量GIP受体激动剂ASC48的三重激动剂组合分别实现12.1%和15.2%的体重下降，较GLP-1/胰淀素双激动剂ASC30_39FDC的6.9%体重下降分别提高约75%和120%。研究结果提示，GIP成分可能是三重激动剂进一步增强减重效果的重要因素。 公司同时披露，选择性胰淀素受体激动剂ASC39在肥胖大鼠中连续口服给药6天后，体重下降6.0%，与皮下注射eloralintide取得的5.0%减重幅度相近。ASC39对人胰淀素1型受体的选择性约为人降钙素受体的40倍。基于此前数据，公司预计GLP-1/胰淀素双激动剂固定剂量复方ASC30_39FDC将于2026年第四季度进入临床。 此外，GLP-1/GIP双激动剂固定剂量复方ASC30_48FDC在非人灵长类动物中连续口服给药8天后实现10.5%的体重下降，较ASC30单药的6.9%进一步提高52%。 由此，歌礼制药形成了从GLP-1单激动剂，到GLP-1/GIP双激动剂，再到GLP-1/GIP/胰淀素三重激动剂的口服小分子产品梯队。与目前以注射多肽为主的减重药市场相比，公司希望通过小分子口服制剂降低给药负担，并以固定剂量复方进一步拓展减重治疗的联合用药选择。 公司现有现金储备预计可支持运营至2029年，覆盖ASC30预计于2028年底提交美国NDA及2029年初提交欧洲MAA的关键节点。 02 Altimmune 2026-08-03美国，临床阶段生物制药公司Altimmune宣布启动PERFORMA III期临床试验，评估其核心候选药物Pemvidutide治疗MASH的疗效与安全性。该研究的启动标志着Pemvidutide继IMPACT IIb期研究取得积极结果后，正式进入全球注册性临床开发阶段。 PERFORMA是一项全球、多中心、随机、双盲、安慰剂对照III期研究，旨在评估Pemvidutide在伴有中重度肝纤维化（F2-F3）的MASH患者中的治疗效果，重点观察肝纤维化改善、MASH缓解以及长期临床结局。研究设计基于美国FDA及欧洲监管机构的沟通反馈，并计划于2029年公布52周阶段性数据。 Pemvidutide是一款创新型肽类药物，通过1:1比例同时激活glucagon receptor和GLP-1受体，兼具降低肝脏脂肪、改善炎症和促进减重的潜力。其中，GLP-1通路主要发挥抑制食欲、促进体重下降等代谢作用，而胰高血糖素受体激活则可直接影响肝脏代谢过程，有望针对MASH这一兼具代谢异常和肝脏损伤特征的复杂疾病。 此前完成的IMPACT IIb期研究显示，Pemvidutide能够显著提高MASH缓解率，同时改善无创肝纤维化指标和肝脏健康指标，并带来具有临床意义的体重下降。基于相关数据，FDA已授予Pemvidutide治疗MASH的快速通道资格（Fast Track Designation）和突破性疗法资格（Breakthrough Therapy Designation）。 PERFORMA研究将包括两个队列。其中，第一队列计划入组约990例患者，通过肝活检评估52周时MASH缓解和/或肝纤维化改善情况，以支持潜在加速审批路径；第二队列计划纳入约800例患者，主要通过无创检测方法进一步扩大安全性数据库。研究还将采用逐步递增给药方案，以提升患者耐受性，并引入FDA认可的AI辅助工具AIM-MASH AI Assist，用于标准化肝组织病理评估。 除MASH外，Altimmune正在拓展Pemvidutide在酒精使用障碍（AUD）和酒精相关肝病（ALD）领域的应用。公司此前公布的RECLAIM II期研究数据显示，Pemvidutide在AUD治疗中亦展现积极信号；针对ALD的RESTORE研究正在推进。 03 恒瑞医药 2026-08-04，恒瑞医药宣布，GLP-1/GIP双重受体激动剂瑞普泊肽（HRS9531，大中华区外称KAI-9531）注射液治疗经二甲双胍单药或联合SGLT2抑制剂治疗后血糖控制不佳成人2型糖尿病患者的中国Ⅲ期临床试验（HRS9531-303）取得积极顶线结果1。瑞普泊肽注射液4mg和2mg两个剂量组均达到预设的主要终点，即HbA1c相对基线的变化均非劣于司美格鲁肽注射液1 mg组。基于本研究结果，恒瑞医药计划近期在中国提交瑞普泊肽注射液用于成人2型糖尿病患者血糖控制的新药上市申请（NDA）。 基于有效性估计目标分析结果显示，治疗36周后，瑞普泊肽注射液4 mg和2 mg组HbA1c平均降幅分别达2.78%、2.34%，相比司美格鲁肽注射液1 mg组（HbA1c平均降幅2.29%），主要终点均达到非劣效。关键次要终点方面，瑞普泊肽注射液 4 mg组HbA1c相对基线的变化与司美格鲁肽注射液1 mg组的组间差异为-0.49% ，优效性检验单侧p<0.0001。在血糖达标率上，瑞普泊肽注射液4 mg和2 mg组HbA1c ≤6.5%的达标率分别为85.0%、69.0%（司美格鲁肽注射液组为64.3%）；HbA1c<7.0%且体重下降≥5%的复合获益达标率分别为66.2%、43.2%（司美格鲁肽注射液组为42.8%）。 安全性方面，瑞普泊肽注射液总体耐受性良好，安全性特征与此前报道的临床数据及其他GLP-1类药物一致。大多数治疗期间出现的不良事件（TEAEs）为轻度至中度，主要为胃肠道相关事件。 04 银诺医药 2026-08-04，银诺医药（Innogen Pharmaceuticals，HX：2591）宣布，其位于苏州的Efsubaglutide alfa生产基地已通过巴西ANVISA依据国际药品检查合作计划（PIC/S） GMP开展的合规检查，并正式获得ANVISA颁发的GMP证书。 此次认证标志着银诺医药质量管理体系获得国际监管机构认可，证明其生产设施已达到PIC/S GMP国际标准。该认证将进一步推动Efsubaglutide alfa在巴西及其他认可PIC/S GMP体系的新兴市场开展注册、准入及商业合作，加快公司代谢疾病创新药的全球化进程。 Efsubaglutide alfa是银诺医药自主研发的人源化超长效GLP-1受体激动剂，目前已在中国大陆及澳门获批用于成人2型糖尿病治疗，并纳入中国国家医保药品目录。SUPER系列关键临床研究显示，该药具有显著降糖效果：在初治2型糖尿病患者中，每周一次3 mg治疗24周后，糖化血红蛋白（HbA1c）较基线平均下降约2.2%；在二甲双胍治疗血糖控制不佳患者中，HbA1c平均下降约1.8%，同时表现出良好的安全性和耐受性，并观察到改善胰岛β细胞功能的潜力。 除糖尿病适应症外，Efsubaglutide alfa在肥胖治疗领域的临床价值也持续得到验证。在中国开展的ENLIGHT IIb期研究中，每周一次20 mg治疗18周后，受试者平均体重下降10.6%，腰围减少约8.9厘米；每两周一次20 mg方案平均减重9.7%，同时改善脂肪量、肝脏脂肪含量及体脂比例等身体组成指标。目前，公司正在澳大利亚开展肥胖症II期临床研究，探索每月一次（Q4W）的给药方案，为未来全球注册和商业化积累数据。 此外，2026年6月，Efsubaglutide alfa用于青少年肥胖治疗的Ib期临床试验获得NMPA批准，并于7月完成首例患者入组，正式进入临床开发阶段。 05 Rhythm Pharma 2026-08-04美国，生物医药公司Rhythm Pharmaceuticals公布其在研药物RM-718治疗获得性下丘脑性肥胖（ HO）的II期临床试验初步结果。数据显示，接受RM-718治疗16周后，患者平均BMI较基线下降11.6%，展现出具有临床意义的减重效果。 该研究为开放标签II期临床试验，共纳入11例获得性下丘脑性肥胖患者。截至2026年7月16日，8例患者仍在接受治疗，其中2例尚未完成16周疗程。初步数据显示，在完成16周治疗的7例患者中，RM-718使平均BMI降低11.6%。该减重幅度与公司此前开发的MC4R通路药物setmelanotide以及bivamelagon的临床表现相当。其中，bivamelagon（600 mg剂量）在14周治疗后平均BMI下降10.1%；setmelanotide在II/III期临床研究中16周治疗后平均BMI下降10.1%。 安全性方面，RM-718整体耐受性良好。最常见的不良事件包括注射部位反应、恶心和呕吐。研究期间仅观察到2例轻度色素沉着事件，且均局限于注射部位，未出现全身性色素沉着。两名患者因不良事件停药，分别为注射部位硬结和恶心。 RM-718是一款每周一次注射给药的MC4R（黑皮质素-4受体）特异性激动剂。临床前研究显示，该药能够降低体重并改善饥饿感。MC4R通路是调控食欲、能量平衡和体重的重要生物机制，其功能异常与部分罕见肥胖疾病密切相关。目前，Rhythm Pharmaceuticals已拥有商业化产品IMCIVREE®（setmelanotide），该药是一款MC4R激动剂，已获美国FDA批准用于治疗包括获得性下丘脑性肥胖、Bardet-Biedl综合征（BBS）相关肥胖以及POMC、PCSK1和LEPR缺陷相关遗传性肥胖等疾病。 除RM-718外，公司还在推进另一款MC4R激动剂bivamelagon以及其他小分子候选药物，用于拓展罕见神经内分泌疾病和代谢疾病治疗领域。此次RM-718 II期临床数据进一步验证了MC4R通路在精准减重领域的潜力。 06 Veru 2026-08-04美国，临床阶段生物制药公司Veru（NASDAQ: VERU）宣布，美国专利商标局（USPTO）已就其专利申请“含选择性雄激素受体调节剂（SARM）化合物与减重药物组合的组合物及其用于高质量减重的用途”发出授权通知（Notice of Allowance）。该通知意味着USPTO已确认该申请满足专利授权要求，预计后续将正式颁发美国专利。 该专利主要覆盖Veru核心候选药物enobosarm与减重药物联合使用的多种治疗方案，包括与semaglutide同步联合治疗、在司美格鲁肽单药治疗基础上加入enobosarm，以及停用司美格鲁肽后继续使用或启动enobosarm单药维持治疗等方案。若正式获批，该专利有效期预计至少持续至2044年10月3日（不考虑潜在专利期限调整或延长）。 该专利覆盖enobosarm用于“高质量减重”（quality weight loss）的多项治疗价值，包括促进瘦体重和肌肉量保持或恢复、增强脂肪减少效果、改善身体组成、提升身体功能，以及降低因肌肉减少导致的跌倒风险、行动障碍和生活质量下降等问题。同时，该专利还涉及改善胰岛素抵抗、降低糖化血红蛋白（HbA1c）、减少GLP-1药物停药后的体重反弹和脂肪反弹，以及预防停药后瘦体重流失等应用。 enobosarm是一种口服选择性雄激素受体调节剂（SARM）。Veru正在开发其作为GLP-1减重疗法的辅助药物，通过促进脂肪选择性减少、保护瘦体重和改善身体功能，提高GLP-1药物带来的减重质量，并有望解决长期减重过程中肌肉流失和停药后体重反弹等关键问题。 目前，Veru正在推进enobosarm联合GLP-1 RA治疗肥胖患者的临床开发。其中，已完成入组的IIb期PLATEAU研究正在评估enobosarm 3 mg联合司美格鲁肽用于65岁以上肥胖患者的疗效和安全性。该研究计划纳入约200名患者，主要评估68周时总体重变化，同时观察脂肪量、瘦体重、身体功能、骨密度以及胰岛素敏感性等指标。中期分析预计于2027年第一季度公布，最终顶线数据预计于2027年第四季度发布。 此前完成的IIb期QUALITY研究显示，在接受司美格鲁肽治疗的老年肥胖患者中，enobosarm联合治疗能够促进脂肪减少，同时保护瘦体重和身体功能；在停用GLP-1药物后，enobosarm单药治疗还显示出减少体重和脂肪反弹的潜力。 07 Toralgen 2026-08-04美国，生物医药公司Toralgen宣布，其自主开发的聚合熊去氧胆酸（polymerized ursodeoxycholic acid，pUDCA）纳米颗粒口服递送平台在多种糖尿病及肥胖（diabesity）相关多肽药物的临床前研究中取得积极结果。研究显示，该平台能够实现单靶点、双靶点及三靶点激动剂多肽药物的口服递送，包括semaglutide、tirzepatide和Retatrutide，为推动下一代口服生物药开发提供新的技术路径。该pUDCA纳米颗粒平台不仅可用于GLP-1类多肽，还计划拓展至蛋白质、抗体等更广泛的生物药领域。 该研究由Toralgen与生物分析服务公司Veloxity Labs合作完成，并于美国糖尿病协会（ADA）第85届科学会议期间公布。研究表明，Toralgen的pUDCA纳米颗粒平台无需针对不同多肽进行专门优化，即可支持多类别多肽药物的口服递送，显示出较强的平台化应用潜力。 在司美格鲁肽相关研究中，该平台实现约7%的相对口服生物利用度，口服暴露水平较目前基于SNAC吸收促进剂的商业化口服制剂提高约5–10倍，同时食物影响较小（低于20%）。此外，该平台还成功实现了双靶点GLP-1/GIP激动剂替尔泊肽以及三靶点GLP-1/GIP/胰高血糖素受体激动剂Retatrutide的口服递送，进一步验证了其在多代谢靶点药物中的应用潜力。 Veloxity Labs则负责该项目中的生物分析方法开发、检测验证、LC-MS/MS分析及药代动力学研究，为多肽药物口服递送效果评估提供关键数据支持。Veloxity Labs首席执行官Shane Needham表示，复杂生物药研发需要与先进分析技术结合，通过高质量药代数据降低研发风险，并支持后续监管申报及商业决策。 目前，Toralgen计划继续推进IND支持性研究，并拓展其口服递送平台在更多治疗领域中的应用。 08 Neurocrine Biosciences 2026-08-07美国，生物制药公司 Neurocrine Biosciences（NASDAQ：NBIX） 宣布启动在研药物 NBIP-1968 的首次人体（First-in-Human）I期临床研究，评估其作为治疗肥胖症的安全性和耐受性。这标志着公司肥胖症研发管线取得重要进展，并进一步强化其在代谢疾病领域的布局。此次I期研究将采用单次递增剂量设计，初步评估不同体重指数（BMI）范围成人受试者（包括超重及肥胖人群）中的安全性和耐受性。 NBIP-1968是一款自主发现的长效三重受体激动剂，旨在同时激活GLP-1受体、GIP受体以及GCGR，计划开发为每周一次皮下注射疗法。NBIP-1968经过长效化设计，目标实现每周一次给药。除NBIP-1968外，Neurocrine正在构建多机制肥胖治疗组合策略。其中，公司另一款候选药物 NBIP-2118 是一种促肾上腺皮质激素释放因子2型受体（CRFR2）激动剂，目前也处于I期临床开发阶段。Neurocrine计划探索NBIP-1968与NBIP-2118的固定剂量联合疗法，以进一步提升减重效果。 Neurocrine Biosciences是一家专注于神经科学、精神疾病、内分泌疾病及免疫疾病领域创新疗法研发的生物制药企业。公司已拥有多个获FDA批准产品，并建立覆盖多个治疗领域的临床研发管线。通过探索脑-身体系统之间的复杂联系，Neurocrine致力于开发改善患者生活质量的新型治疗方案。 企业发展 01 Novo Nordisk 2026-08-04，Novo Nordisk公布2026H1业绩。公司上半年报告销售额1753.11亿丹麦克朗（约273.92亿美元），同比增长18%（按固定汇率CER计算）。 按地域分布来看，2026年上半年美国市场销售额1030.14亿丹麦克朗（约160.96亿美元，+25%），美国外市场销售额722.97亿丹麦克朗（约112.96亿美元，+8%），其中中国市场销售额97.44亿丹麦克朗（约15.23亿美元，0%）。 从业务结构看，Novo Nordisk主要由糖尿病、肥胖护理和罕见病三大板块构成。2026年上半年，糖尿病业务销售额953.65亿丹麦克朗（约149.01亿美元，-5%），肥胖护理业务销售额440.64亿丹麦克朗（约68.85亿美元，+19%）.糖尿病和肥胖护理两大板块合计销售额1394.29亿丹麦克朗（约217.86亿美元），约占调整后总销售额的94%。 司美格鲁肽产品组合是Novo Nordisk上半年最重要的收入来源，覆盖减重产品（Wegovy注射剂、Wegovy口服片剂）和糖尿病产品（Ozempic注射剂、Ozempic pill/Rybelsus），合计销售额1121.93亿丹麦克朗（约175.30亿美元），约占公司调整后总销售额的75.5%。其中，减重产品Wegovy注射剂上半年销售额377.19亿丹麦克朗（约58.94亿美元，+7%）；新推出的减重产品Wegovy口服片剂销售额54.74亿丹麦克朗（约8.55亿美元）。Wegovy口服片剂自2026年1月在美国商业化以来，累计处方量已超过500万张；截至7月17日当周，美国每周处方量超过26.5万张，第二季度处方量约290万张。在糖尿病产品中，注射版Ozempic上半年销售额592.00亿丹麦克朗（约92.50亿美元，-2%）；口服版Rybelsus销售额98.00亿丹麦克朗（约15.31亿美元，-9%）。 02 Lilly 2026-08-05，发布2026H1业绩，上半年总营收427.73亿美元，同比增长49%。 从地区分布来看，上半年美国市场收入265.32亿美元（+37%），欧洲市场收入77.60亿美元（+46%），日本市场收入11.99亿美元（+35%），中国市场收入16.35亿美元（+73%），余下市场收入56.48亿美元（+151%）。 8款核心产品合计收入290.77亿美元，占总营收68%。其中替尔泊肽（Mounjaro和Zepbound）收入276.93亿美元（+88%）；奥氟格列隆（Foundayo）上市第一个季度即畅销9800万美元。礼来的第三款GLP-1产品正在路上，Retatrutide已完成5项III期临床，预计2027Q1递交上市申请。 部分图文来源于网络，如有侵权，请联系删除 旗舰报告 专栏推荐 肽研社 生物医药 · 美妆个护 · 营养健康 动物健康 · 绿色农业 · 生物材料 专业专注 | 成就客户 | 共生成长