Aleniglipron

First patients dosed in Phase 2b ACCESS study of GSBR-1290 for obesity Oral small molecule amylin receptor agonist development candidate expected to be selected by the end of 2024 Strong financial position with cash, cash equivalent and short-term investments of $915.3 million expected to fund projected operations and key clinical milestones through at least 2027 Conference Call to discuss GSBR-1290 ACCESS development program today at 4:30 p.m. ET SAN FRANCISCO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today reported financial results for the third quarter ended September 30, 2024, and highlighted recent corporate achievements. “We are in a period of great momentum and execution at Structure Therapeutics, having begun our next phase of development with GSBR-1290,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “The ACCESS and ACCESS II studies are designed to generate a comprehensive data set that we believe will provide additional insights into the differentiated profile of GSBR-1290 as a potential best-in-class oral small molecule GLP-1 receptor (GLP1-R) agonist. We also plan to declare our first oral small molecule amylin development candidate later this quarter. We look forward to 2025 as a pivotal year for Structure.” Recent and Upcoming Milestones Oral Small Molecule Selective GLP-1R agonist for Obesity (GSBR-1290) Structure announced today a comprehensive development program to further evaluate GSBR-1290 in adults living with obesity or overweight, consisting of the Phase 2b ACCESS study and the Phase 2 ACCESS II study. Structure designed the ACCESS and ACCESS II studies to generate a robust dataset to enable optimized Phase 3 clinical development with the goal of bringing GSBR-1290 to patients as rapidly as possible. ACCESS aims to enroll approximately 220 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate doses up to 120 mg and optimize titration regimens of GSBR-1290 over 36 weeks, following a four-week titration schedule.ACCESS II aims to enroll approximately 82 adults living with obesity, or overweight with a weight-related comorbidity, and is designed to evaluate higher doses (180 mg and 240 mg) of GSBR-1290 over 36 weeks. The first patients have been dosed in the Phase 2b ACCESS study and Structure expects to dose the first patient in ACCESS II by the end of 2024. Topline data from the ACCESS and ACCESS II studies are expected in the fourth quarter of 2025. Oral Small Molecule GLP-1R Combination Programs: Amylin, GIPR, Apelin Receptor (APJR) Oral Small Molecule Amylin Program: Structure Therapeutics is also developing amylin receptor agonists (dual amylin and calcitonin receptor agonists) for potential use either alone or in combination with GLP-1R agonists to treat obesity and associated diseases. Structure recently presented preclinical data related to its amylin program at ObesityWeek® and expects to select a development candidate by the end of 2024.Oral Small Molecule GIPR Program: Structure Therapeutics is developing a GIPR selective agonist and GLP‑1R/GIPR combinations to treat obesity and associated diseases, and expects to select a development candidate in the first half of 2025.Oral Small Molecule APJR Program: Structure Therapeutics is evaluating ANPA-0073, a Phase 2 ready biased APJR agonist for potential selective or muscle-sparing weight loss. ANPA-0073 is also being evaluated for idiopathic pulmonary fibrosis (IPF). Structure Therapeutics has completed a Phase 1 single-ascending and multiple-ascending dose study, in which ANPA-0073 was generally well-tolerated with no serious adverse events reported. Structure Therapeutics is conducting long term chronic GLP-toxicology studies expected to be completed in 2025. Third Quarter 2024 Financial Highlights Cash Position: Cash, cash equivalents and short-term investments totaled $915.3 million on September 30, 2024. The Company expects its current cash, cash equivalents and short-term investments to fund projected operations and key clinical milestones through at least 2027, including all GSBR-1290 studies for Phase 3 readiness but excluding Phase 3 registrational studies. Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were $32.6 million, as compared to $17.5 million for the same period in 2023. The increase was primarily due to increases in research programs and employee expenses related to increases in personnel, as well as the advancement of the Company’s GLP-1R agonist franchise. General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2024 were $13.2 million, as compared to $8.6 million for the same period in 2023. The increase was primarily due to increases in employee related expenses and professional services as the Company expanded its infrastructure to drive the growth in its operations as a publicly-traded company. Net Loss: Net loss for the third quarter of 2024 totaled $34.0 million, with non-cash share-based compensation expense of $6.0 million, compared to $23.9 million for the third quarter of 2023 with non-cash share-based compensation expense of $1.9 million. ACCESS and ACCESS II Conference Call and Webcast InformationStructure Therapeutics will host a conference call and webcast today, November 13, 2024 at 4:30 p.m. Eastern Time to discuss the ACCESS and ACCESS II clinical studies. A live webcast of the call will be available on the Investor Relations page of Structure Therapeutics’ website at https://ir.structuretx.com/events-presentations/events. To access the call by phone, participants should visit this link (registration link) to receive dial-in details. The webcast will be made available for replay on Structure Therapeutics’ website beginning approximately two hours after the live event. The replay of the webcast will be available for 90 days. About Structure TherapeuticsStructure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the manufacturing scalability limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com. 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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; the Company’s anticipated cash runway and uses of cash; any expectations regarding the safety, efficacy or tolerability of GSBR-1290 and other candidates under development; the ability of GSBR-1290 to treat T2DM, obesity or related indications; the planned initiation and study design of the Company’s ACCESS and ACCESS II clinical studies of GSBR-1290 in patients with obesity or overweight with a comorbidity and the timing thereof; the selection of a development candidate for the Company’s amylin receptor agonist program; the timing and design of the Company’s amylin receptor agonist program and its potential as a promising approach to obesity treatment; the timing and design of the Company’s GIPR and GLP-1R/GIPR and other oral small molecule programs; the potential for GSBR-1290 to be a best-in-class oral small molecule; the ability of the Company to bring GSBR-1290 to patients rapidly; the potential applications of ANPA-0073; and the planned timing of the Company’s data results. In addition, when or if used in this press release, the words and phrases “expect,” “on track,” “plan,” “potential,” “promising,” “to be,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the preliminary nature of the results due to length of the study and sample size and results from earlier clinical studies not necessarily being predictive of future results, potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies, the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, competitive products or approaches limiting the commercial value of the Company’s product candidates, the timing and results of preclinical and clinical studies, the Company’s ability to fund development activities and achieve development goals, the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control, the impact of any global pandemics, inflation, supply chain issues, rising interest rates, future bank failures and other macroeconomic factors on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 8, 2024, the Quarterly Report on Form 10-Q filed with the SEC on August 8, 2024, and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. STRUCTURE THERAPEUTICS INC.Condensed Consolidated Statements of Operations(unaudited)(In thousands) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, 2024 2023 2024 2023 Operating expenses: Research and development $32,598 $17,515 $75,327 $50,061 General and administrative 13,238 8,630 35,840 21,720 Total operating expenses 45,836 26,145 111,167 71,781 Loss from operations (45,836) (26,145) (111,167) (71,781)Interest and other income, net 11,951 2,688 25,294 7,212 Loss before provision for income taxes (33,885) (23,457) (85,873) (64,569)Provision for income taxes 92 405 174 548 Net loss $(33,977) $(23,862) $(86,047) $(65,117) STRUCTURE THERAPEUTICS INC.Condensed Consolidated Balance Sheet Data(unaudited)(In thousands) SEPTEMBER 30, DECEMBER 31, 2024 2023Assets Current assets: Cash, cash equivalents and short-term investments $915,286 $467,323 Prepaid expenses and other current assets 8,365 6,285 Total current assets 923,651 473,608 Property and equipment, net 3,735 3,228 Operating right-of-use assets 4,009 5,136 Other non-current assets 1,822 45 Total assets $933,217 $482,017 Liabilities and shareholders’ equity Current liabilities: Accounts payable $8,447 $4,742 Accrued expenses and other current liabilities 23,275 18,558 Operating lease liabilities, current portion 1,712 1,440 Total current liabilities 33,434 24,740 Operating lease liabilities, net of current portion 2,673 4,013 Other non-current liabilities 309 298 Total liabilities 36,416 29,051 Total shareholders’ equity 896,801 452,966 Total liabilities and shareholders’ equity $933,217 $482,017 Investors:Danielle KeatleyStructure Therapeutics Inc.ir@structuretx.com Media:Dan Budwick1ABDan@1abmedia.com

关注并星标CPHI制药在线 减肥药开发是医药行业目前最大的热点之一，甚至有分析机构预测，减肥药市场未来的规模将发展到2000亿美元的水平，几乎可以和目前的肿瘤学产品比肩，因此众多生物医药和科技公司都渴望跻身这个拥有巨大开发潜力的市场之中。诺和诺德的减肥药Wegovy今年第三季度获得了25亿美元的销售业绩，预计明年将拿下130亿美元的全球销售额，并一举跻身重磅炸弹前十名的榜单。在这样一片大好的局面下，即便诺和的Wegovy和礼来的Zepbound把持了目前减肥药市场的绝大部分市场，但仍然有一干减肥药开发商抱着“野芳虽晚不须嗟”的信念在开发减肥药的道路上大干快上。而在另一块平行战场上，减肥药项目和企业的收购竞争也在经历激烈的明争暗斗。 最新的大热收购目标是12年前创立的总部位于加州圣迭戈的Viking Therapeutics。 Viking Therapeutics 的口服多肽减肥药 VK2735 在 1 期临床试验中表现出较高的有效性和安全性，吸引了行业的广泛关注。VK2735 是一种双重 GLP-1/GIP 受体激动剂。在其I期研究中，受试者的体重显著下降，并且VK2735表现出了良好的安全性和耐受性。在 100 mg 的最高剂量组中，VK2735 实现了安慰剂调整后28天6.8%的减重率，这个数据令行业侧目。众多分析师在看好VK2735未来的同时，也纷纷认为Viking Therapeutics将成为制药业巨头收购的下一个热点。 Viking没有稳定的资金注入，独自完成VK2735上市的目标稍显艰巨，尤其是考虑到口服版本的研究仍然处于I期，皮下注射的临床也只是II期，因此需要大量资金的注入才有可能实现产品的上市。之前Viking似乎一直处于“待价而沽”的状态，等待的似乎就是关键里程碑的实现。而如今I期口服制剂数据的出炉似乎就是最好的时机，因此Viking的收购成为了越来越接近现实的交易。 包括辉瑞和阿斯利康在内的多家大型公司在内，他们收购减肥药资产或公司的意愿早已不是秘密。阿斯利康从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004恰好也是一款口服制剂，但不同于VK2735，AZD5004是一款小分子药物。阿斯利康也在近期的ObesityWeek 2024会议上公布了AZD5004的I期数据，显示出5.8%的四周减重率。因此阿斯利康继续收购口服减肥药资产的意愿可能没有那么强烈。而辉瑞在终止了其小分子GLP-1口服减肥药资产lotiglipron之后，又终止了另一款口服小分子减肥药danuglipron每日两剂的临床研究，目前只剩下danuglipron的每日一剂肥胖症项目，因此收购意图可能更为强烈。 除了Viking Therapeutics之外，作为“收购靶点”的公司还包括下列减肥候选药资产拥有者： Structure Therapeutics • 总部：美国加州南旧金山 • 成立时间：2021年 • 市值（2024年11月6日值，下同）：22亿美元 • 主要减肥药资产：Aleniglipron（又名GSBR-1290口服GLP-1受体激动剂），II期数据公布 • 收购看点：Aleniglipron的II期数据与礼来小分子口服GLP-1减肥候药orforglipron可比（12周安慰剂调整后减重率6.2%），但停药率可能较低。小分子口服药具有明显的成本优势，因此代表了减肥药开发的下一波热点。那些拥有口服减肥药资产，且已经产生了不错临床中后期数据的中小公司必然会成为收购重点。 • 收购阻碍：开发位置看上去至少落后orforglipron一年。在机制相同、疗效相近、模态一样的情况下，时间线决定了未来的市场地位和如今的收购价值。 Altimmune Inc. • 总部：美国马里兰州Gaithersburg • 成立时间：1997年 • 市值：5.1亿美元 • 主要减肥药资产：Pemvidutide（每周注射一次多肽GLP-1/胰高血糖素双受体共激动剂），III期研究中。 • 收购看点：长期减重率略优于Wegovy。2.4 mg pemvidutide 48周减重率15.6%。Pemvidutide同时对代谢障碍相关脂肪型肝炎（MASH）进行临床研究。 • 收购障碍：20% 的停药率可能是一个限制因素，但随着患者进入第 3 阶段，允许剂量减少，这应该会对耐受性所有帮助。 Zealand Pharma • 总部：丹麦哥本哈根 • 成立时间：1999年 • 市值：87.6亿美元 • 主要减肥药资产：Survodutide（每周注射一次的多肽GLP-1/胰高血糖素双受体共激动剂），III期临床进行中，授权勃林格殷格翰开发；Dapiglutide（GLP-1/GLP-2共激动剂），II期进行中；Petrelintide（胰淀素类似物），II期进行中。 • 收购看点：Zealand Pharma将根据survodutide全球销售额获取10%左右的版税；项目已经进入III期，有望成为首批Wegovy和Zepbound的挑战者；46周19%减重率；针对MASH开发获得FDA突破性疗法头衔；同时拥有新颖机制的GLP-1/GLP-2双受体共激动剂中期资产，以及胰淀素激动剂中期资产petrelintide。Zealand Pharma在不久前的ObesityWeek 2024会议中公布了petrelintide的I期数据，引发了广泛关注。多次递增剂量 I 期试验数据显示，在16周每周注射一次（剂量分别为 2.4 mg, 4.8 mg 和 9.0 mg）后，平均体重减轻 4.8%、8.6% 和 8.3%，而合并安慰剂组减轻 1.7%。这显示了petrelintide不仅在机制上能够填补目前减肥药的空白，在实际疗效上可能也具备了未来与semaglutide和tirzepatide分庭抗礼的潜力。美国银行分析师表示，他们预计petrelintide将主要用于 GLP-1 不耐受或失败市场（约占 20% 的患者），并预计其年销售额将达到 80 亿美元的峰值。 • 收购障碍：自身被收购意愿可能较低，但Zealand Pharma已经表达出了正在寻找共同开发petrelintide的合作伙伴的动态。与授权survodutide的模式不同，Zealand Pharma将参与petrelintide的开发与商业化的整个过程。Zealand Pharma的CEO表示，目前已就petrelintide的潜在合作开发与前十大制药企业中的一家产生了关联，但不肯透露更多的消息。 Fractyl Health • 总部：美国马萨诸塞州Burlington • 成立时间：2010年 • 市值：1.1亿美元 • 主要减肥药资产：Revita（一种门诊内窥镜手术，通过热液消融持久改变十二指肠功能障碍，从而恢复代谢健康。有证据表明，Revita 可能为肥胖和 2 型糖尿病患者提供持久的体重维持和改善血糖控制。针对接受 GLP-1 药物治疗体重至少减轻 15% 并希望停止使用 GLA-1 药物而不反弹的患者进行临床研究）；Rejuva （一种新型局部给药 AAV 基因疗法，目前处于临床前开发阶段，可改善胰岛功能。通过改变患者的胰腺胰岛细胞中的代谢激素反应，实现持久的体重减轻和 2 型糖尿病的长期缓解。） • 收购看点：提供长期体重管理的方案 • 收购障碍：特殊治疗后产生的不良反应 潜在肥胖症资产和公司买家 • 默沙东（收购意愿：高）：默沙东的药王Keytruda将在2028年专利到期，默沙东对代谢类疾病表现出了高度兴趣，但缺乏GLP-1管线资产。 • 诺和诺德（收购意愿：高）：诺和诺德一直在通过资产购买的方式巩固自己在代谢疾病领域的领先地位。 • 辉瑞（收购意愿：中/高）：辉瑞一直在努力开发口服减肥药，但屡遭挫折。目前几乎硕果仅存的GLP-1小分子减肥候选药daniglupron的前景并不被看好，因此在此路不通的情况下，辉瑞可能选择外部资产的引入。 • 强生（收购意愿：中/高）：近期代谢疾病领域的挫折（Xarelto, Invokana, aprocitentan）大大刺激了强生通过收购外部资产的渴望。 • 礼来（收购意愿：高）：与诺和诺德的减肥药“军备竞赛”。 • 阿斯利康（收购意愿：中/高）：从中国Eccogene Inc.（诚意生物）收购的GLP-1减肥药资产AZD5004令阿斯利康在减肥药竞赛中处于了一个有利的位置。阿斯利康透露出减肥药与Farxiga设计联合疗法的强烈愿望。 • 勃林格殷格翰（收购意愿：高）：BI对于代谢疾病疗法开发具有很高兴趣，其survodutide是从Zealand Pharma获取授权的资产，因此拥有一款独立的减肥药资产对于BI有着强大的吸引力。 • 罗氏（收购意愿：中/高）：最近从Carmot收购GLP-1资产显示了罗氏对开发减肥药的兴趣。罗氏并不算充盈的减肥药管线昭示着可能会有更多的收购项目到来。 • 第一三共（收购意愿：中）：尽管代谢类疾病曾经是第一三共的开发重点，但其目前的核心资产是肿瘤学产品。 • 赛诺菲（收购意愿：中）：赛诺菲的开发中心已经转移到了炎症和免疫产品，但历史上对于代谢疾病的开发可能重燃赛诺菲进军肥胖症的热情。 • 诺华（收购意愿：中）：虽然拥有不少代谢疾病资产，但诺华的核心竞争力在于肿瘤学、免疫学和罕见疾病。 Ref. Malone, E. Top 10 Drugs Q2 2024: Mounjaro Comes Roaring In. Skyrizi Also Makes Its Debut. Scrip. 24. 10. 2024. Structure Therapeutics Reports Positive Topline Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290. Structure Press Release. 03. 06. 2024. Boehringer Ingelheim to advance survodutide into three global Phase III studies in obesity. BI Press Release. 17. 08. 2023. Obesity Drugs: The Next Wave of GLP-1 Competition. New drugs from public and private companies will challenge Novo and Lilly's dominance. Morningstar & PitchBook. Sept. 2024. END 【智药研习社线上研习会报名】 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~