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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 12:31
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· 2025-04-17 17:45
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 10:45
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 11:00
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 13:10
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 11:00
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 12:35
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 13:15
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 13:28
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 ...
Is Viking Therapeutics the Next Blockbuster GLP-1 Stock?
MarketBeat· 2025-03-18 12:46
文章核心观点 GLP - 1疗法在临床减肥治疗领域引发热潮,诺和诺德和礼来在该行业形成寡头垄断,但维京治疗公司的VK2735药物凭借其快速减肥效果和可能的每月一次注射优势,有望打破现有格局,且GLP - 1药物市场预计将大幅增长 [1][3][9] 行业现状 - GLP - 1疗法从名人及网红的非适应症使用开始,随着治疗2型糖尿病药物Ozempic开启潮流而走红,诺和诺德2021年6月推出针对肥胖的司美格鲁肽治疗药物Wegovy,礼来2023年12月推出针对肥胖的GLP - 1/GIP双重激动剂治疗药物Zepbound [1][2] - 分析师预计到2030年GLP - 1药物市场将从900亿美元增长到1500亿美元,诺和诺德和礼来的GLP - 1药物在其营收中占比大,2024年诺和诺德GLP - 1药物营收208.8亿美元,占总营收51.4%,礼来GLP - 1药物营收164亿美元,占总营收37% [9] 维京治疗公司VK2735药物情况 - VK2735是双重GLP - 1/GIP受体激动剂,正在开发注射和口服两种治疗方式,要成为“重磅炸弹”药物需满足疗效、耐受性和独特性等条件 [4][5] - 在减肥效果上,VK2735在第2阶段VENTURE研究中,15mg每周注射13周时平均体重减轻14.7%,安慰剂调整后体重减轻13.1%,减重速度是Zepbound的两倍、Wegovy的五倍 [6][7] - VK2735半衰期为171天,可能推出每月一次的注射方式,这对患者和健康保险公司有吸引力,分析师在其未获FDA批准前就给出较高价格目标,公司将于2025年第二季度进行第3阶段注射试验 [8] - 长期来看,VK2735有可能超过Zepbound在72周时20.1%的安慰剂调整后体重减轻效果,公司已与CordenPharma签订长期合同开发VK2735注射和口服药物配方 [10] 股票评级与预测 - 基于13位分析师评级,维京治疗公司股票当前价格29.83美元,12个月股票价格预测平均为97.67美元,最高预测138.00美元,最低预测38.00美元,评级为买入 [7]