RE: Remaining very optimistic.16 May 2024 13:26
19 December 2023
5 Months in....news must be close?
Simbec-Orion has been appointed as the Contract Research Organisation ("CRO"), for the P140 (Lupuzor™) Phase 3 study in SLE, following extensive due-diligence and a six month tender process, involving 3 different CROs. This was conducted by ImmuPharma's clinical team and agreed with its US partner, Avion Pharmaceuticals, LLC ("Avion")
In addition, ImmuPharma and Avion consider that a Phase 3 dose-ranging study, rather than the longer Phase 2/3 adaptive study is preferable. The direct Phase 3 route is faster to filing for approval whilst also incorporating FDA's request for demonstration of a dose-ranging in the pivotal program.
The international Phase 3 dose-ranging study design and protocol is substantially different from previous clinical trials completed by ImmuPharma. Dosing will still be a subcutaneous injection, once a month, but with significantly higher doses, which have demonstrated safety and tolerability as part of the clinical program. Two planned interim analyses during the course of the study will allow early indications of the effectiveness of P140.
As the study continues to move forward in 2024, further details on the study's timings, protocol and key elements of the clinical trial design will be communicated at regular intervals.