BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes

BMF-219是一种研究性新型共价menin抑制剂，用于再生产生胰岛素的β细胞，旨在治疗糖尿病

The first two type 1 diabetes patients enrolled in COVALENT-112 both demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219

前两名参加COVALENT-112的1型糖尿病患者在接受BMF-219初始治疗后，均表现出临床活动的早期迹象，并改善了β细胞功能

BMF-219 has been well tolerated by both patients

两名患者对BMF-219的耐受性良好

Open label portion of Phase II COVALENT-112 study readout of 40 patients with type 1 diabetes dosed for 12 weeks with BMF-219 expected in 2024

II期共价-112研究读数的开放标签部分，预计2024年将有40名1型糖尿病患者服用BMF-219 12周

First type 2 diabetes patient dosed with BMF-219 for 4 weeks in COVALENT-111 being taken off background therapy (metformin) after week 40, displaying improved glycemic control

第一名2型糖尿病患者在共价111中服用BMF-219 4周，在第40周后停止背景治疗（二甲双胍），血糖控制得到改善

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- 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 initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112)..

加利福尼亚州红木市，2024年4月1日（环球通讯社）--Biomea Fusion，Inc.（“Biomea”）（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，今天宣布了正在进行的II期研究（covalent-112）中使用BMF-219治疗的前两名1型糖尿病患者的初步反应数据。。

“We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study. Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219. We are rapidly gathering significant proof points we believe validate that covalent inhibition of menin leads to the regeneration of beta cells which has been shown to provide disease-modifying patient benefits,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer.

“我们非常高兴地宣布参加共价-112研究的前两名1型糖尿病患者的初步反应数据。两名患者在服用BMF-219仅4周后，β细胞功能指标均有所改善。Biomea Fusion首席医疗官Juan Pablo Frias医学博士表示：“我们正在迅速收集重要的证据，我们认为可以验证共价抑制menin导致β细胞再生，这已被证明可以为改善疾病的患者带来益处。”。

“With BMF-219, we are learning about the potential of restoring the health and function of the beta cell pool in persons with diabetes and how this may lead to the restoration of the ability to produce and secrete insulin, and control blood glucose. These data are preliminary and we look forward to building upon them as we continue enrollment in the open-label portion of COVALENT-112.”.

“通过BMF-219，我们正在了解恢复糖尿病患者β细胞库健康和功能的潜力，以及这可能如何恢复产生和分泌胰岛素以及控制血糖的能力。这些数据是初步的，我们期待着在我们继续注册COVALENT-112的开放标签部分时以此为基础。”。

Dr. Tom Elliott, Medical Director of BC Diabetes (Vancouver, Canada), Clinical Associate Professor of Medicine at the UBC Division of Endocrinology, and a key investigator in the type 1 COVALENT-112 study added, “In my 32 years of practice as an endocrinologist I have never before seen a type 1 diabetes agent achieve such immediate increases in C-peptide secretion.  We need longer-term follow up in a greater number of patients to validate these early signals, but I am very excited for the potential BMF-219 may provide for people with type 1 and type 2 diabetes.

不列颠哥伦比亚大学糖尿病医学主任（加拿大温哥华）汤姆·埃利奥特博士（TomElliott）是UBC内分泌科的临床副教授，也是1型共价-112研究的关键研究者，他补充道：“在我作为内分泌学家32年的实践中，我从未见过1型糖尿病药物能立即增加C肽的分泌。我们需要对更多患者进行长期随访，以验证这些早期信号，但我对BMF-219可能为1型和2型糖尿病患者提供的潜在治疗感到非常兴奋。

This is an unparalleled opportunity to address the root cause of diabetes.” .

这是解决糖尿病根本原因的绝佳机会。”。

COVALENT-112 is a randomized, placebo-controlled, double-blind Phase II study (n=150) designed to examine the safety, efficacy, and durability of BMF-219 in adults diagnosed with type 1 diabetes within 3 years at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period.

COVALENT-112是一项随机，安慰剂对照，双盲II期研究（n=150），旨在检查BMF-219在3年内诊断为1型糖尿病的成年人中的安全性，有效性和耐久性，两种口服剂量水平，100毫克和200毫克，治疗12周，然后是40周的休息期。

The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open label portion (n=40) will also examine the safety, efficacy, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40 week off-treatment period..

该试验包括自诊断以来长达15年的1型糖尿病成人的开放标签部分。开放标签部分（n=40）还将检查BMF-219在两种口服剂量水平（100 mg和200 mg）下的安全性，有效性和耐久性，治疗12周，然后停止治疗40周。。

We are highlighting initial response data from a data cut-off of March 7, 2024 from our first two patients with Stage 3 type 1 diabetes who have received BMF-219 in the open-label portion of COVALENT-112

我们强调了2024年3月7日数据截止的最初反应数据，这些数据来自我们的前两名3型1型糖尿病患者，他们在共价-112的开放标签部分接受了BMF-219

Case Study Patient 1 Highlights

案例研究患者1亮点

A 58-year-old, diagnosed with type 1 diabetes 3 years ago

一名58岁的男子，3年前被诊断出患有1型糖尿病

BMF-219 200 mg once-daily

BMF-219 200毫克，每日一次

Week 4: Fasting C-peptide increased by 57% compared to Baseline (study Day 1). During a mixed-meal tolerance test (MMTT) the C-Peptide Index (AUC) increased by 12%. The C-peptide index is the ratio of serum C-peptide to plasma glucose levels and is used to evaluate β-cell function

第4周：与基线（研究第1天）相比，空腹C肽增加了57%。在混合膳食耐受性测试（MMTT）期间，C肽指数（AUC）增加了12%。C肽指数是血清C肽与血糖水平的比值，用于评估β细胞功能

Week 8: Fasting C-peptide increased by 80% compared to Baseline. During a MMTT, C-peptide increased up to 200%. The C-Peptide Index (AUC) increased by 40% compared to Baseline

第8周：与基线相比，空腹C肽增加了80%。在MMTT期间，C肽增加至200%。与基线相比，C肽指数（AUC）增加了40%

Data on any changes in daily insulin usage are pending

关于每日胰岛素使用量变化的数据尚待确定

Case Study Patient 2 Highlights

案例研究患者2亮点

A 24-year-old, diagnosed with type 1 diabetes 7 years ago

一名24岁的女孩，7年前被诊断出患有1型糖尿病

BMF-219 100 mg once-daily

BMF-219 100毫克，每日一次

Week 4: Fasting C-peptide increased by 16% compared to Baseline. During a MMTT the C-peptide Index (AUC) increased by 30%

第4周：与基线相比，空腹C肽增加了16%。在MMTT期间，C肽指数（AUC）增加了30%

Patient had a near-normal glucose response during the MMTT without receiving any meal-time insulin

患者在MMTT期间血糖反应接近正常，未接受任何餐时胰岛素

Patient had a reduction in daily insulin usage during the first four weeks of the study

在研究的前四周，患者的每日胰岛素使用量有所减少

Dr. Alexander Abitbol, Endocrinologist & Assistant Medical Director at the LMC Healthcare (Ontario, Canada), a key investigator in the type 2 diabetes COVALENT-111 study, and also participating in the type 1 diabetes COVALENT-112 study, provided further color on his experience with the follow-up of his patients after completion of the 26-week COVALENT-111 study, 'The majority of my patients responded to 4 weeks of BMF-219 and continued to see an improvement in A1c over time.

LMC Healthcare（加拿大安大略省）内分泌学家兼助理医学主任Alexander Abitbol博士是2型糖尿病共价-111研究的关键研究者，也参与了1型糖尿病共价-112研究，他在完成26周的共价-111研究后对患者的随访经验提供了进一步的色彩，“我的大多数患者对4周的BMF-219有反应，并且随着时间的推移，A1c持续改善。

Some patients have now completed the 26-week study, and I am pleased to report that I recently discontinued a former study patient’s background antidiabetic medication. This patient is doing particularly well and had an additional 1% HbA1c reduction after he completed the study. It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

一些患者现在已经完成了为期26周的研究，我很高兴地报告说，我最近停用了一位前研究患者的背景抗糖尿病药物。该患者表现特别好，完成研究后HbA1c降低了1%。参加这项研究并探索这条新途径对我们的患者有益，这是令人兴奋的。

I look forward to continuing the enrollment.”.

我期待着继续注册。”。

About Diabetes

关于糖尿病

Diabetes is considered a chronic health condition that affects how the body turns food into energy and results in too much sugar in the bloodstream. Over time, this can cause serious health problems and damage vital organs. Most people with diabetes have a shorter life expectancy than people without this disease.

糖尿病被认为是一种慢性健康状况，会影响身体如何将食物转化为能量，并导致血液中含糖量过多。随着时间的推移，这可能会导致严重的健康问题并损害重要器官。大多数糖尿病患者的预期寿命比没有这种疾病的人短。

The CDC estimates about 2 in 5 of the adult population in the USA are now expected to develop diabetes during their lifetime. More than 37 million people of all ages (about 11% of the US population) have diabetes today, where about 35 million people have type 2 diabetes and about 2 million people have type 1 diabetes.

美国疾病预防控制中心估计，目前预计美国约有五分之二的成年人口在其一生中会患糖尿病。目前有3700多万不同年龄段的人（约占美国人口的11%）患有糖尿病，其中约3500万人患有2型糖尿病，约200万人患有1型糖尿病。

96 million adults (more than 1 in 3) have prediabetes, blood sugars that are higher than normal but not high enough to be classified as diabetes. Diabetes is also one of the largest economic burdens on the United States health care system with $1 out of every $4 in US health care costs being spent on caring for people with diabetes.

9600万成年人（超过三分之一）患有糖尿病前期，血糖高于正常水平，但不足以归类为糖尿病。糖尿病也是美国医疗保健系统最大的经济负担之一，美国每4美元的医疗保健费用中就有1美元用于照顾糖尿病患者。

Despite the current availability of many diabetes medications, there remains a significant need in the treatment and care of patients with diabetes..

尽管目前有许多糖尿病药物可用，但对糖尿病患者的治疗和护理仍有很大需求。。

About COVALENT-111

关于共价111

COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy volunteers were enrolled in single ascending dose cohorts to evaluate safety at the prospective dosing levels for patients with type 2 diabetes. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by standard of care medicines.

COVALENT-111是一项多部位，随机，双盲，安慰剂对照的I/II期研究。在试验完成的第一阶段，健康志愿者被纳入单次递增剂量队列，以评估2型糖尿病患者预期剂量水平的安全性。第二阶段由多个递增剂量队列组成，包括成人2型糖尿病患者，这些患者不受标准护理药物的控制。

Following the Escalation Phase of COVALENT-111, the study has advanced into an Expansion Phase (n>200) consisting of multiple cohorts dosing type 2 diabetes patients for longer dose durations. Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544..

在共价-111的升级阶段之后，该研究进入了扩展阶段（n>200），该阶段由多个队列给药2型糖尿病患者更长的剂量持续时间组成。有关BMF-219在2型糖尿病中的I/II期临床试验的其他信息，请使用标识符NCT05731544在ClinicalTrials.gov上找到。。

About COVALENT-112

关于共价-112

COVALENT-112 is a multi-site, randomized, double-blind, placebo-controlled Phase II study in adults with stage 3 type 1 diabetes. This stage describes the period following clinical diagnosis of type 1 diabetes when symptoms are present due to significant beta cell loss. COVALENT-112 will be a multi-arm trial comparing two different doses of BMF-219 to placebo (1:1:1) to evaluate the safety, tolerability, and efficacy of BMF-219 in adults with type 1 diabetes.

COVALENT-112是一项针对3期1型糖尿病成人的多部位，随机，双盲，安慰剂对照的II期研究。该阶段描述了1型糖尿病临床诊断后的一段时间，当时由于明显的β细胞丢失而出现症状。COVALENT-112将是一项多组试验，比较两种不同剂量的BMF-219与安慰剂（1:1:1），以评估BMF-219在1型糖尿病成人中的安全性，耐受性和有效性。

Approximately 150 patients will be enrolled in the trial and will receive either BMF-219 or placebo for 12 weeks, followed by a 40-week off-treatment period..

大约150名患者将参加试验，并将接受BMF-219或安慰剂治疗12周，然后休息40周。。

This trial also includes an open-label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open-label portion (n=40) will examine the safety, efficacy and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40-week off-treatment period..

该试验还包括自诊断以来长达15年的1型糖尿病成人的开放标签部分。开放标签部分（n=40）将检查BMF-219在两种口服剂量水平（100 mg和200 mg）下的安全性，有效性和耐久性，治疗12周，然后停止治疗40周。。

About Menin’s Role in Diabetes

关于Menin在糖尿病中的作用

Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin.

功能性β细胞质量的丧失是两种糖尿病自然史的核心组成部分-1型糖尿病（由自身免疫功能障碍介导）和2型糖尿病（由代谢功能障碍介导）。β细胞存在于胰腺中，负责胰岛素的合成和分泌。

Insulin is a hormone that helps the body use glucose for energy and helps maintain normal blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta-cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells.

胰岛素是一种帮助身体利用葡萄糖获取能量并帮助维持正常血糖水平的激素。在糖尿病患者中，已观察到β细胞质量和功能减少，导致胰岛素分泌不足和高血糖。Menin被认为是β细胞更新和生长的制动器，支持抑制Menin可能导致正常健康β细胞再生的观点。

Based on these and other scientific findings, Biomea is exploring the potential for BMF-219-mediated menin inhibition as a viable therapeutic approach to potentially halt or reverse progression of type 1 and type 2 diabetes..

基于这些和其他科学发现，Biomea正在探索BMF-219介导的menin抑制的潜力，作为一种可行的治疗方法，可以阻止或逆转1型和2型糖尿病的进展。。

About Biomea Fusion

关于Biomea Fusion

Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response..

Biomea Fusion是一家临床阶段的生物制药公司，专注于发现和开发口服共价小分子，以治疗代谢性疾病和基因定义的癌症患者。共价小分子是一种合成化合物，与靶蛋白形成永久键，与传统的非共价药物相比具有许多潜在优势，包括更高的靶选择性，更低的药物暴露以及驱动更深，更持久的反应的能力。。

We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure..

我们正在利用我们专有的FUSION™系统来发现、设计和开发下一代共价结合小分子药物的管道，旨在最大限度地为患者带来临床益处。我们的目标是对我们服务的患者的疾病治疗产生巨大影响。我们的目标是治愈。。

Visit us at biomeafusion.com and follow us on LinkedIn, Twitter and Facebook.

请访问biomeafusion.com，并在LinkedIn、Twitter和Facebook上关注我们。

Forward-Looking Statements

前瞻性声明

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

我们在本新闻稿中发表的声明可能包括非历史事实的声明，这些声明被视为1933年《证券法》（修订版）（“证券法”）第27A节和1934年《证券交易法》（修订版）（“交易法”）第21E节所指的前瞻性声明。

These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements.

这些陈述可以用“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“计划”、“可能”、“潜在”、“寻求”、“将会”等词语以及这些词语的变体或类似表达来识别前瞻性陈述。

Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including BMF-219, the potential of BMF-219 as a treatment for type 1 and type 2 diabetes, our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials, including our Phase II COVALENT-112 study of BMF-219 in type 1 diabetes, the anticipated enrollment of patients and availability of data from our clinical trials, our plans to advance BMF-219 into a larger, potentially registrational study, and the timing of such events, may be deemed to be forward-looking statements.

本新闻稿中任何不属于历史事实的陈述，包括关于我们的候选产品和开发计划（包括BMF-219）的临床和治疗潜力的陈述，BMF-219作为1型和2型糖尿病治疗的潜力，我们的研究，开发和监管计划，我们正在进行的和即将进行的临床试验的进展，包括我们对1型糖尿病BMF-219的II期共价-112研究，患者的预期登记和临床试验数据的可用性，我们将BMF-219推进更大的潜在注册研究的计划，以及此类事件的时间安排，可能被视为前瞻性陈述。

We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions..

我们打算将这些前瞻性声明纳入《证券法》第27A节和《证券交易法》第21E节所载前瞻性声明的安全港规定，并为遵守这些安全港规定而发表本声明。。

Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities.

本新闻稿中的任何前瞻性声明仅基于截至本新闻稿发布之日我们目前的预期、估计和预测，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性声明中所述或暗示的结果产生重大不利影响，包括我们可能在临床前或临床开发、患者登记以及启动、进行和完成我们正在进行和计划的临床试验以及其他研究和开发活动方面遇到延误的风险。

These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law..

这些与Biomea Fusion业务和运营有关的风险在其向美国证券交易委员会（“SEC”）提交的定期文件中有详细描述，包括其向SEC提交的最新定期报告以及随后的文件。Biomea Fusion明确否认有义务更新任何前瞻性声明，除非法律要求。。

Contact:

联系人：

Investor Relations

投资者关系

Chunyi Zhao, PhD

赵，博士

Associate Director, 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, PhD

Neera Chaudhary，博士

nchaudhary@biomeafusion.com

nchaudhary@biomeafusion.com