Gossamer Bio Prioritizes Pipeline and Reduces Workforce by 25 Percent
May 10, 2023
Rare Daily Staff
Gossamer Bio said it will focus on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension in a business update of its financial results for the first quarter ended March 31, 2023.
Pulmonary arterial hypertension (PAH) is life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly in afflicted patients. PAH is a serious, progressive disease for which there is no cure.
“Our team continues to build momentum across multiple fronts following the positive results from our phase 2 TORREY study of seralutinib in PAH patients. With recent feedback from both the FDA and EMA, we are well positioned to commence our registration program,” said Faheem Hasnain, chairman, co-founder and CEO of Gossamer. “Additionally, we made the difficult decision to undergo an operational restructuring and headcount reduction to prioritize resources around the development of seralutinib. We believe that this restructuring was a necessary step to focus the organization on activities which maximize the potential of seralutinib.
Gossamer has successfully concluded an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration and the Scientific Advice process with the European Medicines Agency (EMA) following the completion of its positive phase 2 TORREY Study in patients with PAH. The company has reached agreement with both FDA and EMA regarding key design elements of the phase 3 program and expects to commence a single registrational phase 3 PAH clinical trial in the third quarter of 2023.
The planned phase 3 clinical trial will be a randomized, double-blind, placebo-controlled, global clinical trial in PAH patients. Patients will be randomized to receive either seralutinib or placebo, in addition to their background PAH therapies. Based on FDA and EMA feedback, Gossamer will test a single dose of 90 mg, twice daily versus placebo. The primary endpoint of the trial will be change in six-minute walk distance from baseline.
Upon completion of the 24-week blinded portion of the phase 2 TORREY Study, patients were able to enroll into an open-label extension trial. Gossamer plans to report initial results from this ongoing open-label extension trial in the middle of 2023.
Clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) is expected to begin in the first half of 2024.
As part of a structural reorganization to center Gossamer around seralutinib and its continued development in PAH, Gossamer reduced its headcount by over 25 percent. Further development of all clinical and preclinical product candidates, outside of seralutinib, has been terminated, and strategic options are being assessed for those candidates.
Photo: Faheem Hasnain, chairman, co-founder and CEO of Gossamer
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