ImmuPharma to split US Ph II and III SLE drug trials

London, UK-based drug firm ImmuPharma says that, following discussions with the US Food and Drug Administration, it is to refine the protocol for Phase II/III trials of its drug candidate, IPP-201101. Development of the agent, which is designed to treat systemic lupus erthematosus, will be split into separate Phase IIb and Phase III studies, as opposed to the combined 12-month assessment originally proposed.

ImmuPharma said that the revision will allow it to produce additional data, thereby enhancing the product's commercial attractiveness and providing for a simpler late-stage development program. The firm, which expects to begin dosing in the Phase IIb trial in the near future, said that the assessment would be run as a randomized, placebo-controlled, dose-ranging study, followed by a three-month extension period. Upon completion, it is expected that patients will be moved into a one-year, open-label extension evaluation.

ImmuPharma added that, if all goes to plan, it will begin the Phase III study in the third quarter of next year. Analysts at Equity research said that the decision to split the Phase II and III trials does not materially alter the product's launch timeline or budget, and may allow the earlier presentation of data to potential licensing partners.