ImmuPharma (AIM:IMM) has initiated IND‑enabling activities for Kapiglucagon and executed a work order with pharmaceutical consultancy tranScrip to develop regulatory strategy and prepare an integrated pre‑IND briefing package for the FDA.
The move positions the specialist drug discovery and development company to follow a streamlined US pathway that could rely partly on existing data for native glucagon, subject to FDA confirmation, and is supported by a recently approved funding initiative intended to advance the asset over the next two years.
"The initiation of IND‑enabling activities represents an important step in advancing Kapiglucagon towards clinical development," said Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma.
Kapiglucagon is a proprietary glucagon prodrug designed to remain soluble and stable in aqueous formulation, regenerate native glucagon in vivo after subcutaneous dosing, and avoid the aggregation that limits use of native glucagon in pump systems.
ImmuPharma says the improved physicochemical profile makes Kapiglucagon suitable for continuous or intermittent delivery in dual‑hormone artificial pancreas systems and other pump‑based settings, with the global insulin pump market forecast at $13.6bn by 2035.
The immediate next milestone is a pre‑IND meeting with the FDA to agree the scope of required CMC, preclinical and clinical work, after which ImmuPharma intends to progress toward IND submission and first‑in‑human studies.
