ImmuPharma PLC (AIM:IMM, OTC:IMMPF) chief executive, Tim McCarthy, described as a ‘significant milestone’ the successful completion of a pharmacokinetic (PK) study of its lead asset Lupuzor, also known as P140.
PK studies are there to assess how the body absorbs, distributes, metabolises, and excretes a compound.
In ImmuPharma’s case, the evaluation was mandated by the US Food & Drug Administration as part of the regulatory sign-off process.
Healthy volunteers were recruited and given a lower and higher dose of P140.
The read-out showed a ‘clear time and dose-related PK profile which is detectable in the blood’, investors were told.
The higher resulted in a ‘successful measurement of the absolute bioavailability of the drug’, the company added.
The read-out, which also showed P140 was safe and well-tolerated, tallied with the outcome predicted in-house.
The next step is to take the asset into a phase III study in people with lupus, an autoimmune disease, and IIa/III assessment of its effects on sufferers of chronic inflammatory demyelinating polyneuropathy, a neurological disorder.
The programmes will be led by ImmuPharma’s partner, Avion Pharmaceuticals.
ImmuPharma CEO McCarthy said: "We are delighted to be announcing this successful readout of the PK study.
“This is a significant milestone for ImmuPharma and for shareholders, and recognition of the key investment thesis behind ImmuPharma, in respect to having P140, a late-stage phase III clinical asset for the treatment of lupus patients with a phase IIa/III pivotal trial in CIDP close behind."