REG - Immupharma PLC - IMM initiatesIND-Enabling Program for Kapiglucagon

ImmuPharmaAnnouncement

Tue 07:00

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RNS Number : 8461C  Immupharma PLC  05 May 2026

This announcement contains inside information for the purposes of the UK
Market Abuse Regulations ('UK MAR'). Upon publication of this announcement,
this inside information (as defined in UK MAR) is now considered to be in the
public domain. The person responsible for arranging the release of this
announcement on behalf of the Company is tim mccarthy, Chief Executive
Officer.

 

 

 

5 May 2026

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

ImmuPharma Initiates IND-Enabling Program for Kapiglucagon to treat Diabetes

ImmuPharma plc, (LSE AIM: IMM), the specialist drug discovery and development
company, is pleased to announce the initiation of IND-enabling activities for
its Kapiglucagon diabetes program, following the execution of a 'Work Order'
with specialist pharmaceutical consultancy tranScrip Limited ("tranScrip").

Under the agreement, tranScrip will support the development of the regulatory
strategy and the preparation and execution of a pre-IND meeting with the FDA,
including the preparation of an integrated briefing package and IND planning
activities.

The program is expected to progress through a streamlined development pathway,
with ImmuPharma evaluating a 505(b)(2) regulatory approach in the United
States, leveraging existing data on native glucagon, subject to FDA
confirmation.

About Kapiglucagon

Kapiglucagon is a proprietary glucagon prodrug being developed for the
treatment of Type 1 diabetes (T1D), to overcome the inherent physicochemical
limitations of native glucagon. The program is designed to improve solubility
and formulation stability, with potential application in dual-hormone
artificial pancreas systems and other glucagon-based therapeutic settings,
which are expected to support the development of next-generation alternatives
to current insulin-only pump devices. Through this innovation, ImmuPharma aims
to contribute to next-generation diabetes care, in which artificial pancreas
systems, may reduce disease burden while improving metabolic control and
patient quality of life. The global Insulin Pump market is forecast to reach
$13.6bn sales by 2035 (Source: Roots Analysis).

ImmuPharma believes Kapiglucagon represents an important strategic
opportunity, alongside its lead asset, P140. ImmuPharma has previously stated
that it has an accelerated development plan for Kapiglucagon, through a
505(b)(2) regulatory pathway (described in notes) and that the program is
being supported by the recently approved funding initiative, which is intended
to advance the asset over the next two years.

Next steps

Kapiglucagon has established a strong scientific rationale and a growing body
of supporting manufacturing and preclinical data, which the Company believes
provides a solid foundation for further development. A key milestone in the
IND-enabling process will be a pre-IND meeting with the FDA to align on the
regulatory pathway and the scope of the required Chemistry, Manufacturing and
Controls (CMC), preclinical and clinical program. Following this meeting,
ImmuPharma intends to progress towards IND submission and, subject to
regulatory alignment, first-in-human studies to support the next stage of
value creation for Kapiglucagon.

Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma, said:

"The initiation of IND-enabling activities represents an important step in
advancing Kapiglucagon towards clinical development. By establishing a clear
regulatory pathway, we aim to efficiently and cost-effectively progress the
program towards first-in-human studies and position it for future partnering
opportunities."

Mark Corbett, Chief Executive Officer of tranScrip, said:

"tranScrip is pleased to be working alongside ImmuPharma at this important
stage of the Kapiglucagon program. By combining regulatory strategy with
hands-on preparation for FDA interaction, we aim to help ImmuPharma move
forward with clarity, confidence and momentum toward IND-enabling milestones."

 

 For further information please contact:

ImmuPharma PLC (www.immupharma.co.uk (http://www.immupharma.co.uk) )  +44 (0) 207 206 2650

 Tim McCarthy, Chief Executive Officer

 Lisa Baderoon, Head of Investor Relations                             + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                               +44 (0) 203 368 3550 (about:blank)

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                              +44 (0) 20 3650 3650

 Patrick Claridge, Bob Pountney

 SI Capital (Joint Broker)                                             +44 (0) 1483 413500

 Nick Emerson

 

Notes to Editors

About ImmuPharma PLC

ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that
discovers and develops peptide-based therapeutics. The Company's portfolio
includes novel peptide therapeutics for autoimmune diseases and
anti-infectives.

 

For additional information about ImmuPharma please visit www.immupharma.co.uk
(http://www.immupharma.co.uk) .

 

ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.

 

Kapiglucagon: A Stable Next-Generation Glucagon Prodrug for Diabetes

 

Kapiglucagon has been developed to address the key pharmaceutical limitations
associated with native glucagon. It is a water-soluble glucagon prodrug
designed to maintain high stability in aqueous solution while regenerating
native glucagon in vivo following subcutaneous administration. Unlike native
glucagon, which rapidly aggregates and forms fibrils in solution, Kapiglucagon
demonstrates excellent solubility and formulation stability, enabling the
development of clean, saline-based formulations that do not clog pump-based
delivery systems. This improved physicochemical profile makes Kapiglucagon
particularly well suited for continuous or intermittent delivery in advanced
diabetes technologies, including next-generation artificial pancreas systems.
By combining the therapeutic activity of native glucagon with a formulation
that overcomes its inherent instability, Kapiglucagon has the potential to
provide more reliable and practical dual-hormone automated glucose control
solutions for patients with Type 1 Diabetes and avoid the long-term health
complications of inadequate blood glucose control.

 

ImmuPharma's vision is to position Kapiglucagon as a key enabling solution for
next-generation artificial pancreas technologies. By overcoming the
long-standing instability of native glucagon in aqueous formulations,
Kapiglucagon offers the potential to deliver a stable, pump-compatible
glucagon source, allowing dual-hormone closed-loop systems to operate safely
and effectively. Through this innovation, ImmuPharma aims to contribute to a
new generation of diabetes care in which artificial pancreas systems can
significantly reduce the daily burden of disease while improving metabolic
control and patient quality of life.

 

About 505(b)(2) regulatory approval

 

A 505(b)(2) is a U.S. FDA drug approval pathway that sits between a full NDA
and a generic. The 505(b)(2) approval route allows a company to obtain
approval for a modified version of an existing drug by relying partly on
data which the FDA already has for the reference product, in this case a
glucagon brand. The timeframe, cost and clinical study requirements for
completing such a program may be considerably reduced compared to a normal NDA
(new drug application) that follows a full 505(b)(1) NDA development
pathway.   A (PTE) Patent Term Extension of 5 years may also be applied to
the existing patent life of Kapiglucagon which could result in a patent expiry
extension to 2043.

 

Kapiglucagon has established a strong scientific rationale and a growing body
of supporting CMC and preclinical data, which the Company believes provides a
solid foundation for further development. The first step is expected to be a
Pre-IND meeting with the FDA to align on the proposed regulatory pathway and
the scope of the required CMC, preclinical and clinical program. Following
this interaction, the Company intends to advance the remaining development
activities, including IND-enabling work, with the objective of entering a
focused clinical study designed to generate safety, pharmacokinetic and
pharmacodynamic data to support the next stage of value creation for
Kapiglucagon.

 

About tranScrip

 

tranScrip is a specialist pharmaceutical consultancy, delivering expert
medical, clinical and regulatory solutions through a multidisciplinary team
that helps transform great science into valuable medicines tranScrip gives
direct access to senior specialist, hands-on drug development experts who help
navigate complexity, reduce risk, maximise opportunities, and make confident
decisions at critical development milestones. For more information go to:
https://transcrip-group.com/ (https://transcrip-group.com/)

 

Glossary

 

CMC        Chemistry, Manufacturing and Controls

FDA         U.S. Food and Drug Administration

IND          Investigational New Drug

NDA        New Drug Application

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