Gossamer Bio plans launch of Phase 3 PAH trial of seralutinib this year
Company recently announced corporate restructuring to focus on seralutinib
Gossamer Bio is planning to soon launch a Phase 3 clinical trial to test its experimental inhaled therapy seralutinib (GB002) in people with pulmonary arterial hypertension (PAH).
“We remain on track to begin our Phase 3 clinical trial of seralutinib in the coming months, moving one step closer toward our goal of bringing a potential new medicine to patients suffering from PAH,” Faheem Hasnain, chairman, co-founder and CEO of Gossamer, said in a company press release.
As part of the trial, participants with PAH will be randomly assigned to take seralutinib (twice daily at a dose of 90 mg) or a placebo on top of standard medications. The study’s main goal will be to assess the impact of treatment on the distance that participants can walk in six minutes (6MWD), a common measure of exercise capacity in people who are able to walk.
The trial’s design was established with feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Gossamer met with these agencies after positive results from a Phase 2 trial.
“Our team continues to build momentum across multiple fronts following the positive results from our Phase 2 TORREY study of seralutinib in PAH patients,” Hasnain said. “With recent feedback from both the FDA and EMA, we are well positioned to commence our registration program.”
Results of Phase 2 seralutinib trial
The Phase 2 TORREY trial (NCT04456998) included 86 people with PAH who were randomly assigned to take seralutinib or a placebo on top of standard-of-care treatment for about six months. The reduction in pulmonary vascular resistance — the resistance against blood flow — was significantly lower, by 14.3%, in patients given seralutinib compared to placebo, results showed.
Those on seralutinib also tended to have better 6MWD outcomes, though the difference from a placebo didn’t reach statistical significance. Most safety-related findings were mild or moderate in severity.
Participants who completed the six-month TORREY study had the option to continue into a long-term extension study, wherein all are being treated with seralutinib and monitored for long-term outcomes. Gossamer said it expects to present interim data from that in the coming months.
The company also plan to start developing seralutinib for pulmonary hypertension associated with interstitial lung disease, a group of disorders marked by lung scarring, in the first half of 2024.
Gossamer recently announced a corporate restructuring to focus its resources on developing seralutinib. The company has reduced its workforce by 25% and stopped developing other potential therapies.
“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,” Hasnain said. “We truly appreciate the hard work and dedication of all of our employees, past and present.”