Feb 6, 2023

ImmuPharma partner agrees phase II/III clinical trial process ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said its partner Avion Pharmaceuticals is to launch an adaptive phase II/III clinical study on Lupuzor, the former’s discovery and putative treatment for systemic lupus erythematosus (SLE). The new study design was influenced by guidance from the US Food & Drug Administration (FDA), which suggested exploring higher dose levels than previously used. It will allow for a dose-range exploration in the phase II stage of the evaluation and a ‘seamless’ progression into the phase III part at the chosen dose, ImmuPharma investors were told. An interim analysis in the phase III portion could potentially bring an early end to the study if an efficacy signal is reached, the company added. The trial is set to commence in the second half of this year, following approval from the FDA/PDUFA process. The new design is expected to make the overall lupus clinical programme faster and less costly, as there will be no need for multiple independent trials, regulatory checks, ethics approvals, and site set-ups. A clean safety profile has already been established at higher doses. ImmuPharma and Avion, along with external advisors, are now preparing an updated clinical protocol.