Therapy Areas: Hereditary Disorders
US FDA grants fast track designation to Proteostasis Therapeutics for cystic fibrosis program
6 April 2018 -

The United States Food and Drug Administration (FDA) has granted fast track designation to United States-based Proteostasis Therapeutics for its triple combination program to treat cystic fibrosis, it was reported yesterday.

The firm's proprietary triple combination includes a novel cystic fibrosis transmembrane conductance regulator amplifier, third generation corrector and potentiator, called PTI-428, PTI-801 and PTI-808, respectively.

The company had previously announced that the protocol for its triple combination clinical study, which it plans to initiate in the current quarter, has received endorsement and a high strategic fit score from the Therapeutics Development Network and the Clinical Trial Network, the drug development arms of the Cystic Fibrosis Foundation and the European CF Society, respectively.

The FDA's fast track designation is designed to facilitate the development and accelerate the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical requirements.



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