ImmuPharma advances Kapiglucagon diabetes drug towards US human trials via FDA pre-IND process

ImmuPharma PLC has initiated regulatory steps to move its Kapiglucagon drug for Type 1 diabetes into human trials in the US. The company is working with tranScrip Limited to prepare for a pre-IND meeting with the FDA, aiming to use an accelerated 505(b)(2) approval pathway that leverages existing data from native glucagon. Kapiglucagon is designed for dual-hormone artificial pancreas systems, potentially improving blood sugar management over current insulin-only pumps. This move supports ImmuPharma's strategy to advance the drug efficiently towards clinical testing and future partnerships.