ImmuPharma PLC (AIM:IMM) said Simbec-Orion has been appointed as the contract research organisation (CRO) to carry out a phase III study of P140 (Lupuzor), a putative treatment for systemic lupus erythematosus (SLE).
The decision comes after a six-month evaluation process involving three different CROs. The appointment marks a pivotal step in advancing the drug towards regulatory approval.
ImmmuPharma chairman Tim McCarthy said: "It has taken longer than we anticipated to fully appraise the three CROs involved in the tender process, however, we were determined to ensure that we chose the most effective organisation that encompassed the high-level clinical expertise required to ensure the highest probability of success for this trial. We are confident that Simbec-Orion meets our criteria."
Additionally, ImmuPharma, in collaboration with its US partner Avion Pharmaceuticals, has opted for a phase III dose-ranging study instead of a longer phase II/III adaptive study.
This decision aligns with the FDA's requirements and aims to accelerate the approval process. The design of this international trial is substantially different from ImmuPharma's previous clinical trials.
It will involve higher doses administered via monthly subcutaneous injections, with two planned interim analyses to assess the drug's effectiveness.
ImmuPharma chairman McCarthy said: "Most importantly, following further detailed analysis of the protocol of this study; new insights into the MOA of P140, combined with the outstanding safety profile of the drug, we have compelling evidence that moving directly into a pivotal phase III study, is the most appropriate route forward and as a result, we have a high level of confidence of the success of this study."
The development of P140 is particularly significant as it represents the only non-immunosuppressing molecule in clinical development for SLE, potentially offering a new standard of care for those suffering from this condition.
Further details about the study's timings, protocol and key elements will be communicated as the study progresses in 2024.