ImmuPharma PLC on Monday confirmed alongside its partner Avion Pharmaceuticals that a phase 2/3 adaptive trial will be the best design for the next clinical study of Lupuzor in systemic lupus erythematosus patients.
The London-based drug discovery and development company said the phase 2 trial will be a one-protocol pivotal study that allows exploration of a dose-range, while phase 3 of the study will investigate a chosen dose.
ImmuPharma said the study is targeted to begin in the second half of 2023, following submission through the US Food & Drug Administration and Prescription Drug User Fee Act process.
The new study design incorporates guidance from the FDA, who 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.
‘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 [the first half of] 2023,’ said ImmuPharma Chief Executive Officer Tim McCarthy.
The stock was down 4.4% at 2.51 pence midday Monday in London.
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