ImmuPharma initiates phase 2/3 clinical trial for lupus treatment
ImmuPharma has announced that it will commence a phase 2/3 adaptive clinical trial of P140 (Lupuzor) in patients with systemic lupus erythematosus (SLE/Lupus), predicted to begin in the second half of 2023.
This announcement follows comprehensive guidance from the US Food and Drug Administration (FDA) from three Type-C meetings, as well as confirmation from Avion Pharmaceuticals which has agreed to continue its support of the clinical trial design, with the two companies agreeing to proceed with preparatory steps for the trial.
More detailed trial protocol and key elements of the trial’s design are expected to be shared at a later stage.
Commenting on this announcement, Tim McCarthy, ImmuPharma’s CEO, stated: “We are delighted to be moving forward with the study for P140 (Lupuzor) in Lupus after receiving comprehensive guidance from the FDA on the protocol. Avion and ourselves are confident in the new design of the Phase 2/3 adaptive clinical trial and in ultimately delivering a new efficacious and safe therapy for Lupus patients.”
Art Deas, Avion Pharmaceuticals’ CEO, added: “The FDA has provided us with comprehensive guidance to commence the Phase 2/3 adaptive clinical trial for P140 (Lupuzor) and we look forward to continue working closely with ImmuPharma to deliver a successful result for Lupus patients.”
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