Gossamer Bio Reports Mixed Results for Seralutinib in PAH, Demonstrates Strong Efficacy in High-Risk Subgroups
Is the current landscape of pulmonary arterial hypertension (PAH) treatments failing to meet the needs of high-risk patients? Gossamer Bio, Inc. a biopharmaceutical company focused on the development and commercialization of seralutinib for PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD), has announced topline results from the PROSERA Phase 3 Study. The study evaluated seralutinib in patients with PAH, showing mixed results overall but significant improvements in high-risk subgroups.
At Week 24, patients receiving seralutinib had a median change of +28.2 meters in 6MWD from baseline, compared to +13.5 meters for those on placebo. The estimated Hodges-Lehmann treatment effect was +13.3 meters, with a p-value of 0.0320, which did not meet the prespecified threshold on the primary endpoint (α = 0.025). However, all four key secondary endpoints favored seralutinib versus placebo in the overall population. “While we are disappointed to have narrowly missed the stringent prespecified statistical threshold for our primary endpoint, the result still clears the traditional 0.05 p-value, and we believe these data clearly demonstrate seralutinib is an active drug in patients with PAH,” said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer Bio.
Key Insights at a Glance
- Primary Endpoint: Seralutinib did not meet the prespecified threshold for the primary endpoint, but showed a statistically significant improvement in 6MWD.
- High-Risk Subgroups: Seralutinib demonstrated a +20.0m placebo-adjusted improvement in 6MWD in intermediate- and high-risk patients.
- Secondary Endpoints: Key secondary endpoints, including NT-proBNP and clinical improvement, favored seralutinib.
- Safety and Tolerability: Seralutinib was generally well tolerated, with 86.5% of patients reporting treatment-emergent adverse events.
Why High-Risk PAH Patients Deserve Better Treatment Options
PAH is a rare, progressive, and often fatal disease characterized by elevated blood pressure in the pulmonary arteries. As the disease advances, patients experience declining exercise capacity and increased risk of heart failure. High-risk patients, defined by the REVEAL 2 Lite Risk Score ≥ 6, face a particularly grim prognosis. Just as a lifeline is crucial in a storm, Gossamer Bio aims to provide a lifeline to these high-risk patients with seralutinib. The drug’s robust performance in this subgroup underscores the urgent need for more targeted and effective treatments.
The Clock Is Ticking on PAH Treatment Innovation
Like a race against time, Gossamer Bio is pushing the boundaries of PAH treatment innovation. The company’s next steps include a meeting with the U.S. FDA to discuss the path forward for seralutinib. The PROSERA results, particularly the significant improvements in high-risk patients, provide a compelling case for further investigation. The company is also pausing enrollment in the SERANATA Study to evaluate the impact of these findings. The coming weeks will bring additional insights from the CT functional respiratory imaging (FRI) substudy, which could further elucidate seralutinib’s treatment effect.
Gossamer Bio Mobilizes for High-Risk PAH Patients
Gossamer Bio is committed to advancing the treatment of PAH, especially for high-risk patients. The company’s seralutinib has demonstrated a statistically robust and clinically meaningful signal in this population, consistent with the Phase 2 TORREY Study. Seralutinib’s differentiated, nonvasodilatory mechanism and its ability to improve key secondary endpoints, such as NT-proBNP and clinical improvement, highlight its potential. Gossamer Bio will continue to engage with regulatory authorities and the medical community to explore the best path forward for seralutinib.
Future Outlook
The journey to improve PAH treatment is like navigating a complex clinical trial landscape, where each step forward is a critical milestone. Gossamer Bio is poised to meet with the FDA to discuss the PROSERA results and explore potential regulatory pathways. The company remains dedicated to addressing the significant unmet need in PAH, particularly for high-risk patients. A replay of the audio webcast will be available for 30 days on the “Investors” section of the company’s website, providing stakeholders with valuable insights into the next steps.
Conclusion
The PROSERA study results highlight the potential of seralutinib to make a meaningful difference in the lives of high-risk PAH patients. Gossamer Bio is committed to advancing this promising treatment and working with regulatory authorities to bring it to those who need it most. Join the conversation in the comments below.
About Pulmonary Arterial Hypertension
PAH is a rare, progressive, and often fatal disease marked by elevated blood pressure in the arteries connecting the right side of the heart to the lungs. Abnormal growth and remodeling of the small pulmonary blood vessels restrict blood flow, increasing strain on the right heart and potentially leading to heart failure. Common symptoms include shortness of breath, fatigue, chest pain, dizziness, and fainting. As the disease advances, patients may experience blood clots within the lungs and declining exercise capacity, ultimately resulting in severe breathlessness and risk of death.
About Gossamer Bio
Gossamer Bio is a biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
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