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速递|Zealand GLP-1/GLP-2新药,28周减轻11.6%!
GLP1减重宝典· 2025-06-25 03:19
整理 | GLP1减重宝典内容团队 致力于创新肽类药物研发的生物技术公司 Zealand Pharma A/S(纳斯达克股票代码:ZEAL)近日宣布,其GLP-1/GLP-2双重受体激动剂 dapiglutide 在I期b阶段多剂量递增(MAD)试验的第二部分中,28周治疗展现出积极的初步结果。此次试验主要评估 dapiglutide 的安全性、 耐受性及临床效果。 在不包含任何生活方式干预(如饮食或运动调整)的前提下,dapiglutide 治疗组参与者在28周后平均体重下降11.6%。试验参与者以男性为主 (约95%),中位体重91.9公斤,起始体重指数(BMI)为28.8 kg/m²。相比之下,安慰剂组平均体重下降仅为0.2%。 "我们对 dapiglutide 在体重管理方面的表现感到鼓舞,特别是在几乎全为男性、且基础体重指数偏低的受试人群中,其效果仍与现有最强效的 GLP-1类药物相当。"Zealand Pharma 首席医疗官 David Kendall 博士表示,"dapiglutide 拥有独特的双机制设计,结合GLP-2活性,或可同时 应对由慢性炎症驱动的肥胖相关共病。我们正在推进一系列差异 ...
Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide
Globenewswire· 2025-06-18 15:29
Company announcement – No. 15 / 2025 Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide Body weight reductions of a mean of 11.6% after 28 weeks with dapiglutide escalated up to 26 mg, with 95% of trial participants being male, a median baseline BMI of 28.5 kg/m2, and no lifestyle modificationsTreatment with dapiglutide was assessed to be safe and well-tolerated with gastrointestinal adverse events consistent with the profile repo ...
Zealand Pharma Announces Financial Results for the First Three Months of 2025
Globenewswire· 2025-05-08 05:00
Core Insights - Zealand Pharma has reported significant progress in its clinical pipeline and has established a transformative partnership with Roche for petrelintide, positioning the company for accelerated growth [1][3]. Financial Performance - For Q1 2025, Zealand Pharma reported revenue of DKK 8.1 million, a decrease from DKK 15.1 million in Q1 2024 [4]. - Operating expenses increased to DKK 393.1 million from DKK 266.3 million year-over-year [4]. - The operating result was a loss of DKK 385.5 million compared to a loss of DKK 255.8 million in the same quarter last year [4]. - The net financial items improved to DKK 70.3 million from DKK 25.8 million [4]. - The cash position as of March 31, 2025, was DKK 8,544.5 million, down from DKK 9,022.0 million at the end of 2024 [4]. Strategic Developments - Zealand Pharma entered a collaboration and license agreement with Roche to co-develop and co-commercialize petrelintide, sharing profits and losses on a 50/50 basis [4][5]. - The partnership aims to establish a leading amylin-based franchise for weight management and related indications [5]. - Zealand Pharma completed enrollment in the Phase 2 ZUPREME-1 trial for petrelintide three months after initiation [5][9]. Corporate Updates - Utpal Singh was appointed as Chief Scientific Officer to lead the next wave of innovative medicines [5][10]. - Steven R. Smith was appointed as Senior Global Medical Advisor in Obesity to support obesity research and clinical development programs [8]. Upcoming Milestones - Zealand Pharma expects to submit a Marketing Authorization Application for glepaglutide in the second half of 2025 and initiate a Phase 3 clinical trial [12]. - The company anticipates reporting topline results from the Phase 2 ZUPREME-1 trial in the first half of 2026 [14]. - Zealand Pharma plans to host a Capital Markets Day in London on December 11, 2025 [17]. Financial Guidance - The financial guidance for 2025 remains unchanged, with net operating expenses expected to be between DKK 2,000 million and DKK 2,500 million [18][19].