Specialist drug discovery and development company ImmuPharma plc (LSE AIM: IMM) announced on Monday that it has selected Kymos Germany/Prolytic, part of Kymos Group, as its bioanalytical contract research organisation partner for the Kapiglucagon programme following a competitive tender process.
Kymos Group will develop and validate regulated bioanalytical methods and analyse samples from Kapiglucagon's non-clinical and Phase 1 clinical programmes. The appointment follows the selection of Thermo Fisher as CMC partner and Bachem AG as API manufacturing partner.
Kapiglucagon is a proprietary glucagon prodrug being developed for Type 1 diabetes applications, designed to improve the solubility and formulation stability of native glucagon and potentially enable use in dual-hormone artificial pancreas systems.
ImmuPharma is evaluating a US 505(b)(2) regulatory pathway, subject to FDA confirmation, which could leverage existing data on native glucagon and potentially reduce development requirements compared with a conventional NDA pathway.
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