ImmuPharma Says Lupus Treatment Study Met Key FDA Endpoints
April 13 2022 - 3:12AM
Dow Jones News
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
April 13, 2022 02:57 ET (06:57 GMT)
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