ImmuPharma Initiates IND-Enabling Program for Kapiglucagon via FDA 505(b)(2) Pathway

ImmuPharma's decision to pursue a 505(b)(2) regulatory pathway for Kapiglucagon signals a deliberate CMC and IND preparation strategy that smaller peptide-focused biotechs are increasingly adopting to reduce duplicative nonclinical work and compress development timelines. The LSE-listed company has confirmed it is preparing for a pre-IND meeting with the FDA as part of IND-enabling activities for the proprietary glucagon prodrug, subject to FDA confirmation of the pathway.

Kapiglucagon is engineered to address the formulation instability that has historically constrained native glucagon in clinical settings, with targeted application in dual-hormone artificial pancreas systems and Type 1 diabetes management. For regulatory affairs leads, the 505(b)(2) election here is consequential: it permits reliance on existing safety and efficacy data for glucagon, but places the CMC burden squarely on demonstrating that the prodrug's stability profile and release kinetics are sufficiently characterised to satisfy FDA's expectations at IND stage. Peptide prodrugs carry specific analytical method development challenges that teams will need to resolve before the pre-IND submission package is finalised.

The company's full-year results for the twelve months ended 31 December 2025 show R&D expenditure of £1.3m against a net loss of £1.8m, a reduction from the £2.5m loss recorded in 2024. A £6.47m fundraise completed on 7 April 2026, structured through a £6m Lanstead Capital subscription and a £0.47m retail offer, brings the operational runway needed to advance both Kapiglucagon's IND-enabling work and the lead P140 autoimmune platform toward a licensing transaction.

P140 continues to anchor the portfolio. A Combined Search and Examination Report was issued for the UK patent application filed in September 2025, and a scientific manuscript is in preparation for peer-reviewed submission. The programme is being co-developed with the Type M companion diagnostic platform, designed to stratify autoimmune patients by response profile, a precision medicine architecture that carries its own regulatory implications under 21 CFR Part 820 and applicable IVD frameworks if the diagnostic advances alongside the therapeutic.

Board and leadership changes are also in effect: Dr Sébastien Goudreau has been promoted to Chief Scientific Officer, Dr Laura Mauran-Ambrosino to Head of Research and Development, and Ketan Patel has joined as an independent Non-Executive Director.

The measurable near-term checkpoint is the outcome of the pre-IND meeting with FDA, which will determine whether the 505(b)(2) route is confirmed and define the data package required to support a full IND submission for Kapiglucagon.

Source: ImmuPharma PLC via LSE regulatory announcement, 27 May 2026.