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REDWOOD CITY, Calif., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (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 that the U.S.

加利福尼亚州红木市，2024年9月26日（环球通讯社）--Biomea Fusion，Inc.（“Biomea”或“公司”）（纳斯达克：BMEA），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基因定义癌症患者的生活，今天宣布美国。

Food and Drug Administration (FDA) has lifted the clinical hold on Biomea’s ongoing Phase I/II clinical trials of the Company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. “We greatly appreciate FDA’s review of our data, and the swift resolution of the clinical trial hold.

美国食品和药物管理局（FDA）解除了对Biomea正在进行的I/II期临床试验的临床限制，该试验分别针对2型和1型糖尿病（共价-111和共价-112）的研究性共价menin抑制剂BMF-219。“我们非常感谢FDA对我们数据的审查，以及临床试验的迅速解决。

The in-depth review of the clinical data to date reconfirms our confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes. We are encouraged from the safety review of the ongoing Phase 2b Expansion Study, where the concerning safety signals seen in the Phase 2a Escalation Study did not translate over to the larger Expansion Study.

迄今为止，对临床数据的深入审查再次证实了我们对BMF-219作为治疗糖尿病的新型一流药物的信心。我们从正在进行的2b期扩展研究的安全审查中受到鼓舞，在2a期升级研究中看到的相关安全信号没有转化为更大的扩展研究。

And most importantly, none of the elevated lab values translated to confirmed serious liver injury or liver impairment,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “We look forward to continuing our robust development plan for BMF-219 following full resumption of our ongoing studies, COVALENT-111 and COVALENT-112.” Conference Call and Webcast Details Webcast of Biomea’s investor update today, Thursday, September 26th at 4:30 pm ET will be available to registered attendees under the Investors and Media section of the company’s website at https://investors.biomeafusion.com/news-events/events.A replay of the presentation will be archived on Biomea’s website following.

最重要的是，没有一个升高的实验室值被证实为严重的肝损伤或肝损伤，”Biomea Fusion首席执行官兼董事会主席托马斯·巴特勒（ThomasButler）表示。“在全面恢复我们正在进行的研究COVALENT-111和COVALENT-112之后，我们期待着继续我们对BMF-219的稳健发展计划。”电话会议和网络广播详细介绍了Biomea投资者更新的网络广播，今天，9月26日星期四，美国东部时间下午4:30，将在公司网站的投资者和媒体部分向注册与会者提供https://investors.biomeafusion.com/news-events/events.A演示文稿的重播将存档在Biomea的网站上。

Investor Relations

投资者关系

Chunyi Zhao, PhD

赵，博士

Associate Director of Investor Relations & Corporate Development

投资者关系与公司发展副总监

czhao@biomeafusion.com

czhao@biomeafusion.com

Media Relations

媒体关系

Neera Chaudhary

尼拉·乔杜里

nchaudhary@biomeafusion.com

nchaudhary@biomeafusion.com