Posted by Michael Wonder on 13 Oct 2016
FDA fast track designation and first subject dosing with lead candidate CC8464/ASP1807 for the management of neuropathic pain associated with iSFN
13 October 2016 - Chromocell Corporation and Astellas Pharma Inc. announced today that the U.S. FDA has granted fast track designation to the development program of the drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy (iSFN).
In 2015, Chromocell and Astellas entered into a license and collaboration agreement for the development and commercialization of CC8464/ASP1807 for the management of neuropathic and other pain indications.
Chromocell submitted the IND for CC8464/ASP1807 in July, 2016, and recently dosed the first subject in a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the oral formulation of CC8464/ ASP1807.
