Clinical stage biopharma company Proteostasis Therapeutics (PTI) announced positive preliminary results from a Phase 1 study for the treatment of cystic fibrosis (CF) patients. Shares of Proteostasis jumped more than 350% with a huge trading volume and reached a new 18-month high of $9.07 during Thursday’s mid-day trading.
Proteostasis Therapeutics is developing a new triple-combination CF therapy comprised of three agents; PTI-428, PTI-801, and PTI-808. At the time of data cut, 21 subjects were randomized and treated with these three agents. The results were as expected and in terms of safety, the compounds were generally well tolerated.
The data from the fourth dosing cohort is expected in the first quarter of 2019 and Proteostasis anticipates starting Phase 3 studies within the next 12 to 18 months. In early April, FDA granted Fast Track Designation for the company’s triple combination program for the treatment of CF.
Cystic fibrosis is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time. According to a report from Research and Markets, the global cystic fibrosis therapeutics market is expected to grow at a CAGR of 17.28% during the period 2018-2022.
The Boston, Massachusetts-based biotech firm hopes to reach data milestones in the next several months. CEO Meenu Chhabra stated that Proteostasis will expand exploration of partnering opportunities across its product portfolio and in various geographies.
Vertex Pharmaceuticals (VRTX), AstraZeneca (AZN), Gilead Sciences (GILD) and Novartis (NVS) are some other pharma companies that are currently conducting trials for treating cystic fibrosis. Vertex stock dropped about 4% in the morning session today.