NeuroSearch now seeking global Huntexil partner
NeuroSearch A/S (CSE:NEUR) said it is now seeking a worldwide partnership for Huntexil pridopidine after it was unable to secure a deal that would have excluded European rights to the Huntington's disease product. The company attributed the difficulty in finding an ex-European partner to an increased risk for the program in the U.S. Last year, both FDA and EMA requested additional Phase III data to support Huntexil's previously observed effect on the total motor score (TMS) and to substantiate the clinical relevance of the effect. NeuroSearch added that FDA also requested evidence of a significant effect on an endpoint to support clinical relevance and also recommended investigating doses higher than those used in previous Phase III trials.
Additionally, NeuroSearch said it is in dialogue with existing shareholders and potential new investors about a possible financing to fund internal development of Huntexil, including the planned Phase III Prime-HD trial to address the FDA and EMA requests. ...