First clinical site now open for large trial testing seralutinib for PH-ILD
Positive results could support applications for approval of inhaled therapy
The first clinical site is now active for a global Phase 3 study that will evaluate Gossamer Bio’s therapy candidate seralutinib in people with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Dubbed SERANATA, the study aims to enroll about 480 people with PH-ILD, ages 18 to 80. No location information has been shared as yet by the developer.
But, if positive, the trial’s results could support applications seeking regulatory approval of seralutinib for people with PH alongside ILD, a group of conditions that cause inflammation and scarring (fibrosis) in lung tissue.
“We are encouraged by the engagement from the PH-ILD community as we begin to activate the first clinical sites in the SERANATA Phase 3 study,” Faheem Hasnain, CEO, chairman, and cofounder of Gossamer, said in a company press release. “We are excited to begin enrollment, and we are hopeful that our collective efforts will ultimately improve the lives of patients living with PH-ILD.”
Hasnain added that the company is “grateful for the opportunity to collaborate closely with physicians and patients to better understand the challenges for those living with this challenging and undertreated disease.”
Seralutinib, an inhaled therapy, was originally developed to block signaling proteins that promote inflammation, abnormal cell growth, and fibrosis. Such processes can cause the pulmonary arteries to thicken and narrow, leading to pulmonary arterial hypertension (PAH).
Similar structural changes in the lung’s blood vessels occur in PH-ILD, where the same processes are driven by underlying conditions that cause fibrosis in the lungs.
SERANATA to test long-term safety, effectiveness of seralutinib
Participants in the SERANATA trial (NCT07181382) will be randomly assigned to receive either seralutinib, at 90 mg or 120 mg twice daily, or a placebo. After the initial 24-week treatment period, those who received the placebo will be able to switch to active seralutinib therapy. All patients will then be followed during a 144-week, or nearly three-year, extension phase.
The main goal of the study’s first part is to evaluate the impact of seralutinib on performance in the six-minute walk test (6MWT) after 24 weeks, or about six months. The 6MWT measures how far a person can walk in six minutes and is a standard way to assess exercise capacity in people who can walk.
Researchers will also track other outcomes, such as time to clinical worsening and changes in forced vital capacity (FVC) — the amount of air a person can exhale after a deep breath — as an indicator of lung function.
The extension phase is designed to assess the treatment’s long-term safety and effectiveness. Changes in 6MWT and FVC will also be evaluated during this period to determine whether benefits in exercise capacity and lung function are sustained over time.
A now-completed Phase 2 trial called TORREY (NCT04456998) tested seralutinib against a placebo in 86 adults with PAH. Seralutinib was given on top of standard of care therapy. Those results showed that the experimental treatment significantly improved several measures of heart and lung function, as well as exercise capacity, compared with the placebo.
Ongoing PROSERA trial assessing therapy in PAH patients
Gossamer is now also conducting another global Phase 3 clinical trial to test seralutinib. The ongoing PROSERA study (NCT05934526) is evaluating the medication in nearly 400 people with PAH. Top-line results from PROSERA are expected in early 2026.
“We are proud to be progressing through the final stages of the PROSERA Phase 3 study. This is a pivotal moment for our team, and I am continually impressed by the focus, diligence, and professionalism that everyone brings to this important work. We look forward to sharing top-line results with the community in February of next year,” Hasnain said.
Data shared by the company at this year’s European Respiratory Society congress in Amsterdam showed that treatment with seralutinib reduced levels of PRO-C6, a mediator of inflammation and fibrosis, along with other markers of fibrosis and inflammation.
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