ImmuPharma Launches IND-Enabling Program for Kapiglucagon in Diabetes Treatment
ImmuPharma has initiated IND-enabling activities for its Kapiglucagon diabetes program, collaborating with tranScrip Limited. This program aims to utilize a 505(b)(2) regulatory approach to advance Kapiglucagon, which targets Type 1 diabetes treatment.
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ImmuPharma plc has begun IND-enabling activities for Kapiglucagon, a prodrug aimed at treating Type 1 diabetes, in partnership with tranScrip Limited. The initiative includes preparing for a pre-IND meeting with the FDA and developing a regulatory strategy to support a 505(b)(2) pathway, leveraging existing glucagon data.
The program is designed to enhance solubility and stability, potentially benefiting dual-hormone artificial pancreas systems. A pre-IND meeting will establish the regulatory pathway and necessary CMC requirements, with plans for IND submission and first-in-human studies thereafter. The global insulin pump market is projected to reach $13.6 billion by 2035, highlighting the potential impact of Kapiglucagon on diabetes care innovation.
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