Andrzej Rostek
INmune Bio (NASDAQ:INMB) said that an FDA clinical hold on a Phase 2 study for its drug XPro in the treatment of Alzheimer’s disease will remain in place pending additional information on long-term potency, but that shouldn’t affect the study being completed on time.
INmune said the hold will not impact its progress in completing the Phase 2 study on time as its patient recruitment projections are reliant on sites located outside the US.
The study has testing sites in Australia, Canada, the UK, Poland, France and Spain, with plans to expand into other EU nations. The FDA is the only agency to place a hold on the study, the company added.
The biotech company said it intends to provide the information requested by the FDA before the end of the year.
