(Sharecast News) - Specialist drug discovery and development company ImmuPharma reported positive data from its 'Lupuzor' pharmacokinetic study on Wednesday, as part of the new, optimised international third phase trial in lupus patients.
The AIM-traded firm said the study had met the key endpoints as requested by the United States Food and Drug Administration (FDA).
It said the dosing of healthy subjects started on 15 February following approval by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
Subcutaneous injection of Lupuzor, or 'P140', showed a "clear time and dose-related" pharmacokinetic profile, which was detectable in the blood of human volunteers and applicable for all potential clinical dosing regimens.
The final group of subjects completed dosing on 30 March, and received an intravenous injection of a 800 mcg dose of P140, which showed successful measurement of the absolute bioavailability of the drug as a control.
ImmuPharma said importantly, and in-line with all human dosing to date, P140 was "safe and well-tolerated" across all doses and in all subjects.
The positive pharmacokinetic data now cleared the path for the start of all clinical studies within the P140 platform, the board said.
In addition to lupus, there was a planned phase 2a and 3 pivotal trial in chronic inflammatory demyelinating polyneuropathy (CIDP).
The company's US partner Avion Pharmaceuticals was working with ImmuPharma in preparing the next steps for progressing the P140 clinical programme.
"We are delighted to be announcing this successful readout of the pharmacokinetic study," said chief executive officer Tim McCarthy.
"This is a significant milestone for ImmuPharma and for shareholders, and recognition of the key investment thesis behind ImmuPharma, in respect to having P140 as a late-stage phase 3 clinical asset for the treatment of lupus patients, with a phase 2a and 3 pivotal trial in CIDP close behind."
At 1337 BST, shares in ImmuPharma were up 51.52% at 8.56p.
Immupharma (IMM)