ImmuPharma PLC (AIM:IMM, FRA:25I), the drug discovery company, has appointed Thermo Fisher Scientific to develop and manufacture the finished form of its experimental diabetes treatment Kapiglucagon.
The US group was chosen after a competitive tender, with its Patheon pharma services arm taking on the drug product workstream.
The appointment follows the recent selection of Swiss group Bachem to manufacture the active ingredient, completing the main manufacturing partnerships for the programme.
Kapiglucagon is a prodrug version of glucagon, a hormone that raises blood sugar, designed for use in Type 1 diabetes.
A prodrug is an inactive compound that converts into the active medicine inside the body, an approach used here to get around glucagon's tendency to be poorly soluble and unstable once mixed into a formulation.
ImmuPharma is targeting dual-hormone artificial pancreas systems, devices that deliver both insulin to lower blood sugar and glucagon to raise it, mimicking the function of a healthy pancreas.
The company is evaluating a 505(b)(2) route in the United States, a regulatory pathway that allows developers to lean on existing safety data for an approved drug rather than repeating the full testing programme.
That approach relies on published data for native glucagon and remains subject to confirmation by the Food and Drug Administration.
Sébastien Goudreau, chief scientific officer, said the appointment strengthened the manufacturing and quality foundation of the programme as it moves towards clinical development.
Jennifer Cannon, president of commercial biopharma services at Thermo Fisher, said her team would support ImmuPharma through key development milestones.
The next stage involves preparing an investigational new drug application, the submission required before human testing can begin in the United States.
ImmuPharma has described Kapiglucagon as a strategic opportunity alongside P140, its lead candidate for the autoimmune disease lupus.
The programme is backed by a funding package approved recently and intended to advance the asset over the next two years.
