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Ascletis Announces Positive Topline Results of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 and Submission of 13-week Phase IIa Study Protocol to FDA
Prnewswire· 2025-04-23 07:30
- ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 10 mg, 20 mg, and 40 mg doses. - ASC30 oral once-daily tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 5 mg, 10 mg, and 20 mg doses. No vomiting was seen in this dose group. - Data from three different weekly titration sc ...
MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential
Prnewswire· 2025-04-22 20:31
药物DA-1726的临床效果 - 在8 mg至32 mg剂量范围内观察到明显的剂量依赖性体重减轻趋势,表明更高剂量和更长使用时间可能带来更佳效果 [2] - 32 mg剂量组在第26天显示出最大体重减轻6.3%和平均体重减轻4.3% (p=0.0005) [3] - BMI变化显示治疗组与安慰剂组差异更为明显,进一步支持药物的剂量依赖性效果 [2] - 32 mg剂量组在第26天观察到空腹血糖最大降低18 mg/dL和平均降低5.3 mg/dL [3] - 32 mg剂量组在第33天观察到腰围最大减少3.9英寸和平均减少1.6英寸 [3] 药物安全性 - 在4周内接受高达32 mg DA-1726的受试者中未观察到药物诱导的心血管效应 [1] - 所有治疗组(4、8或32 mg每周一次)的平均心率在4周后下降-14至-0.7 bpm,而16 mg组增加7.7 bpm [4] - 未报告QTcF间隔>480-500 msec或>500 msec的发作,未识别心血管事件风险 [4] - 32 mg剂量组中6名受试者有4名出现轻度胃肠道不良事件,大部分在24小时内缓解 [7] - 未出现治疗相关停药或严重不良事件 [7] 药物机制与优势 - DA-1726是一种新型双重oxyntomodulin类似物激动剂,作用于GLP1R和GCGR [1] - 采用3:1的GLP-1R与GCGR激活比例 [3] - 相比现有GLP-1激动剂,可能解决20-30%患者首月停药和高达70%一年内停药的问题 [5] - 临床前小鼠模型中,DA-1726比semaglutide(Wegovy®)和cotadutide(另一种OXM类似物)显示出更好的减重效果 [9] - 与tirzepatide(Zepbound®)和survodutide相比,DA-1726在减重同时能保持更多瘦体重并显示更好的降脂效果 [9] 临床试验设计 - 研究为随机、双盲、安慰剂对照设计,评估DA-1726在肥胖健康受试者中的安全性、耐受性、药代动力学和药效学 [6] - MAD部分纳入BMI 30-45 kg/m2的健康成人 [6] - 主要终点是通过监测不良事件评估DA-1726的安全性和耐受性 [6] - 次要终点包括通过血清浓度随时间变化评估DA-1726的药代动力学 [6] - 探索性终点包括DA-1726对代谢参数、心脏参数、空腹血脂水平、体重、腰围和BMI等的影响 [6] 公司发展计划 - 计划进行Phase 1 Part 3研究,评估早期停用Wegovy®的患者使用DA-1726的情况,旨在展示更好的耐受性、安全性和减重效果 [5] - 将增加更高剂量组以评估最大耐受剂量,充分实现DA-1726的潜力 [5] - 公司认为32 mg可能成为未来临床试验的起始剂量 [4] - 公司已行使1,430,000股普通股的预融资认股权证 [8]
Eli Lilly: Cementing Its GLP-1 Empire With Orforglipron's Promising Phase 3 Results
Seeking Alpha· 2025-04-18 01:45
Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive a ...
Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial
Prnewswire· 2025-04-17 18:45
Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across dosesThe investigational once-daily oral pill reduced weight by an average 16.0 lbs (7.9%) at the highest dose in a key secondary endpointThe overall safety and tolerability profile of orforglipron in ACHIEVE-1 was consistent with injectable GLP-1 therapies INDIANAPOLIS, April 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline Ph ...
RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption
Prnewswire· 2025-04-16 19:00
GLP-1 comparable efficacy: Opaganib's positive results, newly published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models--Novel mechanism of action, formulation and administration: Opaganib is a differentiated oral, non-peptide therapeutic that targets sphingosine kinase-2 (SPHK2), potentially avoiding common Glucagon-like peptide-1 (GLP-1) inhibitor side effects and administration burdens --Market ...
Lexaria Updates its Ongoing Human Study GLP-1-H24-4
Thenewswire· 2025-04-03 21:10
Registered Phase-1b 12-week study investigating safety, diabetes control, and weight loss Kelowna, British Columbia – April 3, 2025 – TheNewswire - Lexaria Bioscience Corp. (NASDAQ:LEXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to provide this progress update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the “Study”) underway in Australia. Enrollment of patients for all 5 Study arms has now been completed on schedule. Participation interest in the Stu ...
Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation
GlobeNewswire News Room· 2025-04-01 19:00
New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) ("the Company"), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive early data from the open-label REVEAL-1 cohort of its on ...
The Vitamin Shoppe® Unveils First-of-its-Kind Supplement Line Formulated for GLP-1 Users
Prnewswire· 2025-03-31 20:35
The dietitian formulated, doctor-approved GLP-1 Support from Whole Health Rx™ by The Vitamin Shoppe® range of supplements delivers comprehensive nutritional solutions for individuals on GLP-1 weight- loss medications SECAUCUS, N.J., March 31, 2025 /PRNewswire/ -- The Vitamin Shoppe®, a leading omni-channel specialty retailer of nutritional products, today announced the launch of GLP-1 Support from Whole Health Rx™ by The Vitamin Shoppe®, an innovative line of dietary supplements designed to address the uniq ...
Beyond GLP-1 Drugs: This Opportunity at Eli Lilly Could Surprise Everyone in 2025
The Motley Fool· 2025-03-27 21:15
文章核心观点 - 礼来公司不仅有GLP - 1药物带来增长,Kisunla在阿尔茨海默病治疗领域有潜在机会,当前股价估值压缩是投资契机 [1][3][13] 礼来公司业务情况 - Mounjaro是公司最大收入来源,Zepbound是增长最快业务,2024年首个完整日历年销售额近50亿美元 [4] - 公司还有治疗癌症、斑块银屑病、湿疹等疾病的市场领先药物,Kisunla获FDA批准进入阿尔茨海默病治疗领域 [5] 阿尔茨海默病行业情况 - 全球阿尔茨海默病市场规模约80亿美元,预计到2033年将增长近四倍至310亿美元,且市场较分散 [6] 竞品情况 - 目前较流行的阿尔茨海默病治疗药物Leqembi由Biogen和Eisai开发,2023年7月获FDA批准,12月正式推出 [7] - 2024年4 - 12月Leqembi销售额为296亿日元(1.98亿美元),Eisai将其2024年全年预测从565亿日元下调至425亿日元 [8] 投资分析 - 礼来当前远期市盈率为36,较一年前低约40%,估值压缩或因未获FDA批准的仿制药GLP - 1兴起 [10][12] - 公司通过加强自身制造能力和直接价格竞争应对仿制药,投资者2025年应关注Kisunla推出及公司在阿尔茨海默病治疗方面的发展 [12][13]
Structure: A Lot Riding On Next Data Readout For Oral GLP-1 Candidate
Seeking Alpha· 2025-03-20 21:28
If you like what you have just read and want to receive at least 4 exclusive stock tips every week focused on Pharma, Biotech and Healthcare, then join me at my marketplace channel, Haggerston BioHealth . Invest alongside the model portfolio or simply access the investment bank-grade financial models and research. I hope to see you there.When I last covered Structure Therapeutics (NASDAQ: GPCR ) in a note for Seeking Alpha back in August last year, I gave the South San Francisco-based biotech's stock a "Buy ...