Phase 2/3 adaptive study design for Lupus study agreed with Avion6th February 2023 - 1:24 pm
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, provides an update to the market on its Lupuzor™ programme in patients with systemic lupus erythematosus (“SLE”)
- In conjunction with its partner Avion Pharmaceuticals (“Avion”), ImmuPharma confirms that a Phase 2/3 adaptive trial will be the best design for the next clinical study of Lupuzor™ in SLE patients
- The study is targeted to commence in H2 2023 following submission through the FDA/PDUFA* process
ImmuPharma confirms that with its partner Avion, they have agreed on an adaptive Phase 2/3 study for Lupuzor™ in SLE patients. This is a one-protocol pivotal study which allows exploration of a dose-range in the Phase 2 part of the study, followed by seamless progression into the Phase 3 part of the study at the chosen dose. The overall timelines for the lupus clinical program are shorter as one avoids the need for stopping and starting two independent trials, regulatory checks, ethics approvals and site set-ups. It is also expected to be less costly overall. There is also an opportunity, through an interim analysis in the Phase 3 part of the study, to stop the study earlier if an efficacy signal is reached after a certain percentage of patients have been treated.
This new study design incorporates guidance from the Food and Drug Administration (“FDA”) which advised exploration of higher dose levels than have been used in the clinical program to date. A clean safety profile has already been established at higher doses. The ImmuPharma/Avion team, together with external advisors, are now preparing an updated clinical protocol.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:
“We have had extremely productive discussions with Avion over the last few weeks on the Lupuzor™ programme and we have agreed that the optimum way forward for Lupuzor™ is to undertake an adaptive Phase 2/3 trial. Our key focus will be to commence the trial during H2 2023.”
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