OPKO Health, Inc.  and Entera Bio Ltd., a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and license agreement to advance into the clinic the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders.

OPKO Health, Inc. 与口服肽和蛋白质替代疗法开发领域的领导者 Entera Bio Ltd. 达成合作和许可协议，以推进首个口服双激动剂 GLP-1/胰高血糖素肽进入临床，作为每日一次的片剂治疗肥胖、代谢和纤维化疾病的患者。

The program combines OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tabtechnology. Favorable pharmacodynamic, pharmacokinetic and bioavailability data in vivo were reported in September 2024. The companies expect to file an Investigational New Drug application with the FDA later this year..

该计划结合了OPKO专有的长效氧调蛋白类似物（OPK-88006）和Entera专有的N-Tab技术。2024年9月报告了在体内的良好药效学、药代动力学和生物利用度数据。公司预计将在今年晚些时候向FDA提交新药临床试验申请。

Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro-rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. In connection with the execution of the agreement, OPKO purchased 3,685,226 ordinary shares of Entera for a purchase price equal to $2.17 per share.

根据协议条款，OPKO和Entera将分别持有该项目60%和40%的按比例所有权权益，并分别承担该项目60%和40%的开发成本。与协议的执行相关，OPKO以每股2.17美元的价格购买了Entera的3,685,226股普通股。

Entera has agreed to utilize the proceeds from the sale of the shares to fund its 40% share of costs through Phase 1 of the development program. Following the completion of the Phase 1 stage, Entera has the option to continue to fund its 40% share to maintain its pro-rata ownership interest of the program.

Entera 已同意利用出售股份所得收益，为开发计划第一阶段的成本提供其40%的份额。在第一阶段完成后，Entera 有权选择继续为其40%的份额提供资金，以维持其在该项目中的按比例所有权权益。

Should Entera opt-out, Entera will retain a 15% ownership interest in the Oral OXM program, while OPKO will retain 85% and be responsible for ongoing development activities and funding of the program..

如果Entera选择退出，Entera将保留口服OXM项目15%的所有权，而OPKO将持有85%并负责项目的持续开发活动和资金投入。

“We are pleased to continue working with Entera on this promising program to develop the first oral GLP-1/glucagon dual agonist in addition to our subcutaneous injectable dual agonist GLP-1/glucagon program. Our goal with this franchise is to provide additional options for patients with obesity, metabolic and fibrotic diseases,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO..

“我们很高兴继续与Entera合作开展这一前景广阔的项目，开发首款口服GLP-1/胰高血糖素双重激动剂，此外还有我们的皮下注射型GLP-1/胰高血糖素双重激动剂项目。我们在此领域的目标是为肥胖、代谢和纤维化疾病患者提供更多的治疗选择，”OPKO董事长兼首席执行官Phillip Frost博士表示。

“We have enjoyed our synergistic partnership with OPKO. This expanded collaboration on the GLP-1/glucagon program reinforces our shared vision to develop first in class differentiated oral peptide treatments for patients to better manage their health,” said Miranda Toledano, Entera Chief Executive Officer..

“我们与OPKO的协同合作非常愉快。此次在GLP-1/胰高血糖素项目上的扩展合作，进一步巩固了我们共同的愿景，即开发同类首创的差异化口服多肽治疗方案，帮助患者更好地管理自身健康，”Entera首席执行官米兰达·托莱达诺表示。

Oxyntomodulin is a naturally occurring GLP-1/glucagon dual agonist peptide hormone found in the small intestine that acts to suppress appetite, induce weight loss and has additional cardioprotective and anti-fibrotic attributes. OPK-88006 is a GLP-1/glucagon dual agonist peptide that has been modified to maintain its long-acting profile while increasing its potential potency.

Oxyntomodulin 是一种天然存在于小肠中的 GLP-1/胰高血糖素双效激动剂肽激素，具有抑制食欲、减轻体重的作用，并且还具备额外的心脏保护和抗纤维化特性。OPK-88006 是一种经过修饰的 GLP-1/胰高血糖素双效激动剂肽，旨在保持其长效特性的同时提高潜在效力。

Currently, there are no approved dual GLP-1/glucagon agonists available..

目前，尚无获批的双重 GLP-1/胰高血糖素激动剂可用。

Condition:

条件：

Obesity

肥胖症

Type:

类型：

drug

药物