Proteostasis Therapeutics, Inc. (NASDAQ: PTI) shares perked Wednesday, after the company disclosed that it has received the Food and Drug Administration’s (FDA) Fast Track designation for triple combination program in patients with cystic fibrosis.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
An investigational drug that receives Fast Track program designation is eligible for more frequent communications between the FDA and the company relating to the development plan and clinical trial design, and may be eligible for priority review if certain criteria are met.
CEO Meenu Chhabra told the media, "Fast Track designation represents another positive step for the development of our triple combination therapy and underscores the serious unmet need that remains for the vast majority of CF patients.
"We believe this designation, together with other recent designations from regulators and CF organizations following review of our results with PTI-428, PTI-801 and PTI-808, is recognition of the potential of these programs in this disease. We believe combinations of CFTR modulators hold the promise of improving treatment efficacy for different segments of the CF population”.
The Cambridge, Mass.-based Proteostasis is a clinical stage biopharmaceutical company developing small molecule therapeutics to treat cystic fibrosis and other diseases caused by dysfunctional protein processing.
The shares climbed 48 cents, or 10.7%, to $4.93 as morning became afternoon on Wednesday.
