ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said its partner Avion Pharmaceuticals has submitted the phase II/III clinical protocol for Lupuzor to the US Food and Drug Administration (FDA).
This promising treatment is for patients with systemic lupus erythematosus (SLE/Lupus). The new trial design addresses the US regulator's guidance on exploring higher dose levels and incorporates insights from the pharmacokinetic (PK) study completed last year.
As a result, the phase II portion of the trial, which should get underway in the second half, is expected to identify a dose level several times higher than the 200mcg dose used in ImmuPharma's previous phase III evaluation.
In addition, the method of administration will change from a subcutaneous injection to an intravenous injection, aiming to achieve significantly higher blood levels of Lupuzor (P140) and increasing the likelihood of a significant efficacy result for patients.
A clean safety profile has already been established for the putative treatment at higher doses. This preserves the treatment's target product profile, which includes significant efficacy for patients without serious side effects, the company said.
Tim McCarthy, chief executive of ImmuPharma, said both Avion and ImmuPharma believe the new design of the phase II/III adaptive study offers the greatest probability of success for the benefit of Lupus patients. The trial is on track to commence in the second half of 2023.