ImmuPharma PLC (AIM:IMM, FRA:25I) has selected Kymos Group as bioanalytical partner for Kapiglucagon, completing the outsourced development chain assembled for its diabetes candidate in recent months.
The drug discovery company said Kymos, a European contract research organisation certified under good laboratory practice and inspected by the US Food and Drug Administration, had won a competitive tender.
The new partner will develop and validate the regulated methods used to measure the drug in biological samples, then analyse material generated during non-clinical work and a planned Phase 1 trial.
The appointment follows the selection of Thermo Fisher for chemistry, manufacturing and controls work and Bachem AG to produce the active ingredient.
Together the three contracts give ImmuPharma the infrastructure needed to file an investigational new drug application, the submission required before human testing can begin in the US.
Kapiglucagon is a prodrug, an inactive compound converted into a therapeutic once inside the body, designed to overcome the poor solubility and formulation instability of native glucagon.
Those limitations have held back dual-hormone artificial pancreas systems, which pair insulin with glucagon to guard against dangerous falls in blood sugar in Type 1 diabetes.
ImmuPharma is evaluating a 505(b)(2) filing, an abbreviated US route that leans on existing data for an approved substance, subject to FDA confirmation.
The programme is backed by a £6.47 million raise completed in April, led by Lanstead Capital Investors, funding a two-year development plan.
Sébastien Goudreau, chief scientific officer, said the appointment was another step in building the development infrastructure required to take Kapiglucagon towards the clinic.
P140, the autoimmune platform, remains the group's principal value driver, with management targeting a licensing deal this year.
