By Anthony O. Goriainoff


ImmuPharma PLC said Wednesday that its lupus treatment Lupuzor/P140 met the required key endpoints in the pharmacokinetic study requested by the U.S. Food & Drug Administration.

The London-listed drug company said that in line with all human dosing to date, Lupuzor was safe and well tolerated across all doses and in all subjects.

The company, which focuses on autoimmune diseases, metabolic diseases, anti-infectives and cancer, said the data was part of the new Phase 3 trial of Lupuzor in lupus patients.

A pharmacokinetic study times the course of a drug's movement into, through, and out of the body and studies how the body affects a drug.

ImmuPharma said the data opened the way for the start of all clinical studies within the P140 platform, and that in addition to lupus it also planned to conduct a Phase 2a/3 trial in chronic inflammatory demyelinating polyneuropathy, or CIDP, an autoimmune disorder.

"This is a significant milestone for ImmuPharma and for shareholders, and recognition of the key investment thesis behind ImmuPharma, in respect to having P140 (Lupuzor), a late-stage Phase 3 clinical asset for the treatment of lupus patients with a Phase 2a/3 pivotal trial in CIDP close behind," Chief Executive Tim McCarthy said.


Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com


(END) Dow Jones Newswires

04-13-22 0257ET