ImmuPharma PLC (AIM:IMM, OTC:IMMPF) is set to initiate a Phase 2/3 adaptive clinical trial for its P140 (Lupuzor) drug in systemic lupus erythematosus patients during the second half of 2023.
The new trial phase follows comprehensive guidance received from the US Food and Drug Administration (FDA).
Avion Pharmaceuticals has confirmed its commitment to support the new clinical trial design, and ImmuPharma and Avion will now embark on preparatory measures for the Phase 2/3 adaptive clinical trial.
ImmuPharma noted that significant changes have been made to the trial design and protocol compared to previous clinical trials.
The subcutaneous dosing will be maintained but at higher concentrations, while patient inclusion criteria and primary and secondary clinical endpoints have undergone substantial modifications.
Further information regarding the trial, including the detailed protocol and key elements of the clinical trial design, will be made available at a later stage through clinicaltrials.gov.
"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,” said ImmuPharma’s chief executive Tim McCarthy, adding: “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."
“We look forward to continue working closely with ImmuPharma to deliver a successful result for Lupus patients," Avion’s chief executive Art Deas added.