Proteostasis Therapeutics Wins Big With FDA Decision

Proteostasis Therapeutics Inc. (NASDAQ: PTI) shares made a solid gain on Wednesday after a key U.S. Food and Drug Administration (FDA) decision was announced. This is yet again proof that the FDA has the potential to make and break companies in the biopharma industry.

The FDA has granted Fast Track Designation for the company’s triple combination program for the treatment of cystic fibrosis. The 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.

Back in January, Proteostasis 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.

Overall, 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.

Meenu Chhabra, president and CEO of Proteostasis, commented:

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, including F508del heterozygotes and F508del homozygotes, where patients have limited access to treatment, are underserved by existing treatments or see a declining benefit in lung function over time.

Excluding Wednesday’s move, Proteostasis had underperformed the markets in 2018, with the stock down about 24%. However, over the past six months the stock is up roughly 112%.

Shares of Proteostasis were last seen up about 6% at $4.72, with a consensus analyst price target of $16.00 and a 52-week trading range of $1.41 to $8.61.