Posted by Michael Wonder on 04 Apr 2018
Proteostasis Therapeutics receives FDA fast track designation for triple combination program in patients with cystic fibrosis
4 April 2018 - Proteostasis Therapeutics today announced that the U.S. FDA has granted fast track designation for the company's triple combination program for the treatment of cystic fibrosis.
The Company's proprietary triple combination includes a novel cystic fibrosis transmembrane conductance regulator (CFTR) amplifier, third generation corrector and potentiator, known as PTI-428, PTI-801 and PTI-808, respectively.
The Company announced in January that the protocol for its triple combination clinical study, which the Company plans to initiate in the current quarter, has received endorsement and a high strategic fit score from the Therapeutics Development Network (TDN) and the Clinical Trial Network (CTN), the drug development arms of the Cystic Fibrosis Foundation (CFF) and the European CF Society (ECFS), respectively.
