Liquid Glucagon: Improving Utilisation for Emergency Treatment of Severe Hypoglycemia

液体胰高血糖素：提高严重低血糖紧急治疗的利用率

• 批准号: 102838
• 金额: $ 133.72万
• 依托单位: ARECOR LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=102838
• 关键词: Liquid; Glucagon; Improving; Utilisation; Emergency

Arecor is a world leader in developing stable formulations of therapeutics, with in-house development programmes aimed at differentiated product concepts in diabetes. Arecor has solid plans for developing those product concepts to Phase I clinical proof-of-concept and subsequent licensing of the assets. One of the product concepts is liquid glucagon, both for emergency use and as a critical component for a bihormonal pump. Arecor has developed prototype liquid formulations of glucagon showing sufficient stability for a viable commercial product. With the critical support from InnovateUK, Arecor is progressing this asset through pre-clinical development by performing further optimisation to ensure compatibility with a selected delivery device, toxicology studies, formal stability studies and validated pharmacokinetic studies. Following this study, Arecor will be ready to move into Phase I human trial. Stable liquid glucagon product will transform the way glucagon is used for emergency treatment of severe hypoglycaemia episodes by removing the need for a complex reconstitution of the currently marketed lyophilised products. In addition, there is a recognised need for liquid glucagon as a critical component of bihormonal pumps that will also be addressed by this product.

Arecor是开发稳定的治疗制剂的世界领导者，其内部开发计划旨在实现糖尿病差异化产品概念。Arecor有坚实的计划，将这些产品概念发展到第一阶段临床概念验证和随后的资产许可。其中一个产品概念是液体胰高血糖素，既可用于紧急情况，也可作为双激素泵的关键成分。Arecor已经开发出胰高血糖素的原型液体制剂，其显示出对于可行的商业产品足够的稳定性。在InnovateUK的关键支持下，Arecor正在通过临床前开发来推进这一资产，通过进一步优化来确保与选定的输送设备、毒理学研究、正式的稳定性研究和经验证的药代动力学研究的兼容性。在这项研究之后，Arecor将准备进入I期人体试验。稳定的液体胰高血糖素产品将改变胰高血糖素用于重度低血糖发作的紧急治疗的方式，因为无需对目前市售的冻干产品进行复杂的复溶。此外，人们认识到需要液体胰高血糖素作为双激素泵的关键组分，本产品也将解决这一问题。