ImmuPharma PLC (AIM:IMM, FRA:25I), the drug discovery company, has kicked off the regulatory groundwork needed to advance its Kapiglucagon diabetes programme towards human trials in the United States.
The company has engaged tranScrip Limited, a specialist pharmaceutical consultancy, to develop its regulatory strategy and prepare for a pre-IND (investigational new drug) meeting with the US Food and Drug Administration (FDA).
Kapiglucagon is a proprietary glucagon prodrug, a chemically modified version of the hormone glucagon designed to be more stable and easier to formulate than its natural form, intended for the treatment of Type 1 diabetes.
ImmuPharma is pursuing a 505(b)(2) regulatory pathway, an accelerated US approval route that allows developers to rely partly on existing data from previously approved compounds, in this case, native glucagon, subject to FDA confirmation.
The drug is designed for use in dual-hormone artificial pancreas systems, next-generation devices that manage blood sugar by delivering both insulin and glucagon automatically, and which the company believes could reduce patient burden compared with current insulin-only pump technology.
The global insulin pump market is forecast to reach $13.6 billion in sales by 2035, according to research firm Roots Analysis.
ImmuPharma's chief scientific officer, Sébastien Goudreau, said the programme was being advanced "efficiently and cost-effectively" with a view to first-in-human studies and future partnering opportunities.
The Kapiglucagon programme sits alongside P140, ImmuPharma's lead asset, and is being supported by a recently approved internal funding initiative intended to advance it over the next two years.