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Biomea Fusion展示BMF-219治疗糖尿病患者的长期26周随访数据

Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function

GlobeNewswire 等信源发布 2024-03-06 16:04

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Three Clinical Data Sets from the Dose Escalation Phase of COVALENT-111 to be Presented at the 17th Annual ATTD Conference Highlighting BMF-219’s Novel Mechanism of Action in Patients with Type 2 Diabetes Patients in COVALENT-111 are displaying improved glycemic control while off therapy out to Week 26 following the 28-day treatment with BMF-219, supporting enhanced pancreatic islet function as the mechanism of actionBMF-219 was generally well tolerated with no serious adverse events and no adverse event-related study discontinuations, and no symptomatic or clinically significant hypoglycemia100mg and 200mg dose levels have been selected for the first 3 Arms of the Expansion Phase, which will dose patients up to 12 weeks (compared to 4 weeks in the Escalation Phase) and extended follow-up to Week 52The Expansion Phase of COVALENT-111 is currently enrolling on schedule with initial 26-week data expected during 2H24Biomea Fusion to announce an update on the first two patients with Type 1 Diabetes, from the COVALENT-112 Study, in the Q4 2023 Earnings Release REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc.

将在第17届ATTD年会上提交的共价-111剂量递增阶段的三个临床数据集强调了BMF-219在2型糖尿病患者中的新作用机制共价-111患者在接受28天的BMF-219治疗后第26周停止治疗时血糖控制得到改善,支持胰岛功能增强,因为BMF-219的作用机制通常耐受性良好,没有严重的不良事件,也没有不良事件相关的研究中断,也没有症状或临床上显着的低血糖选择100mg和200mg剂量水平用于扩张阶段的前三组,这将给患者服用12周(与升级阶段的4周相比)并将随访时间延长至第52周COVALENT-111的扩展阶段目前正在如期注册,预计在2H24Biomea融合期间会有最初的26周数据,以宣布前两名1型糖尿病患者的最新情况,根据COVALENT-112研究,在2023年第四季度的收益发布中,加利福尼亚州红木市,2024年3月6日(环球通讯社)——Biomea Fusion,Inc。

(“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study (COVALENT-111), at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy from March 6-9, 2024.

(“Biomea”)(纳斯达克股票代码:BMEA)是一家临床阶段的生物制药公司,致力于发现和开发口服共价小分子,以治疗和改善代谢性疾病和遗传性癌症患者的生活,今天宣布了三张海报,展示了BMF-219治疗患者26周的长期随访数据,2024年3月6日至9日,在意大利佛罗伦萨举行的第17届糖尿病先进技术与治疗国际会议(ATTD)上,参加了正在进行的II期临床研究(COVALENT-111)的升级部分。

This clinical data from all dosing cohorts init.

来自所有给药队列的临床数据。