ImmuPharma has reported that its Phase II/III adaptive study of P140 (Lupuzor) for the treatment of systemic lupus erythematosus (SLE/Lupus) is set to begin in the second half of this year.
The latest decision comes after the company received comprehensive guidance from the US Food and Drug Administration (FDA) in three separate Type-C meetings.
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The trial design includes dosing of patients subcutaneously at much higher concentrations compared to previous clinical trials.
Significant changes have also been made to patient inclusion criteria, as well as primary and secondary clinical endpoints.
ImmuPharma and Avion Pharmaceuticals will support the new clinical trial design and begin preparatory steps as part of the licence agreement between the companies.
ImmuPharma CEO Tim McCarthy said: “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.
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By GlobalData“Avion and ourselves are confident in the new design of the Phase II/III adaptive clinical trial and in ultimately delivering a new efficacious and safe therapy for Lupus patients.”
ImmuPharma said that the key elements of the trial design and detailed protocol will be announced later.
Avion Pharmaceuticals CEO Art Deas said: “The FDA has provided us with comprehensive guidance to commence the Phase II/III adaptive clinical trial for P140 (Lupuzor) and we look forward to continue working closely with ImmuPharma to deliver a successful result for Lupus patients.”
