ImmuPharma PLC (AIM:IMM, FRA:25I), the drug discovery and development company, has appointed Swiss manufacturer Bachem to produce the active pharmaceutical ingredient for its Kapiglucagon programme, following a competitive tender.
Bachem is a global peptide and oligonucleotide manufacturer that supports drug companies from early development through to commercial supply.
The appointment marks a milestone in the chemistry, manufacturing and controls work that underpins drug development, and is expected to support the next stage of preparation for Kapiglucagon.
Kapiglucagon is a proprietary glucagon prodrug being developed for type 1 diabetes, a precursor compound designed to overcome the physical and chemical limitations of native glucagon.
The programme aims to improve solubility and formulation stability, with potential use in dual-hormone artificial pancreas systems and other glucagon-based treatments.
ImmuPharma regards the drug as an important strategic opportunity alongside its lead asset, P140.
The company has said it intends to pursue a 505(b)(2) regulatory pathway in the United States, a route that allows applicants to rely in part on existing data, in this case for native glucagon, subject to confirmation from the Food and Drug Administration.
The immediate focus will be the ingredient workstream with Bachem, followed by the appointment of a separate partner to handle formulation and manufacturing of the finished drug product.
ImmuPharma will continue to advance its regulatory strategy in parallel, working towards an investigational new drug submission and eventual first-in-human studies, subject to agreement with health authorities.
Sébastien Goudreau, chief scientific officer, said the appointment strengthened the foundation for moving the programme towards the clinic
