(Alliance News) – ImmuPharma PLC on Monday confirmed together with partner Avion Pharmaceuticals that an adaptive phase 2/3 trial will be the best design for the next clinical study of Lupuzor in patients with -systemic lupus erythematosus.
The London-based drug discovery and development company said the phase 2 trial will be a pivotal single-protocol study that allows exploration of a dose range, while the phase 3 of the study will investigate a selected 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 design of the new study incorporates guidance from the FDA, which advised on the exploration of higher dose levels than those 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 past few weeks regarding the Lupuzor program and have agreed that the best way forward for Lupuzor is to conduct an adaptive phase 2/3 trial. Our main focus will be to we start the trial during [the first half of] 2023,” said ImmuPharma CEO Tim McCarthy.
The stock was down 4.4% at 2.51 pence on Monday in London.
By Greg Rosenvinge, Alliance News reporter
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