Pulmonary Arterial Hypertension (PAH) is a rare but debilitating condition characterized by elevated blood pressure in the pulmonary arteries, leading to breathlessness and chest pain. It can manifest as idiopathic PAH or be associated with various underlying causes. The primary approach to managing PAH involves using medications that expand the pulmonary arteries and reduce pressure to improve patients’ symptoms and overall quality of life.

PAH presents a challenging and often grim prognosis for those affected. According to DelveInsight’s epidemiological assessment, an estimated 88,100 individuals were living with PAH in 2022, of which about 52,860 cases were diagnosed across the 7MM regions, which include the United States, EU4 (Germany, France, Italy, Spain), the UK, and Japan. This staggering statistic underscores the urgent need for ongoing research and advancements in diagnosing and treating PAH to offer hope to those grappling with this debilitating condition.

The European Respiratory Society (ERS) conference in 2023 featured a significant presentation by Gossamer Bio, a clinical-stage biopharmaceutical company committed to advancing seralutinib as a potential treatment for PAH. Gossamer Bio shared pioneering findings from the functional respiratory imaging (FRI) sub-study within the Phase II TORREY Study, which underscored seralutinib’s efficacy in reducing pulmonary vascular resistance under the presentation titled – “Seralutinib improves pulmonary arterial blood vessel volume distribution in pulmonary arterial hypertension (PAH): results of the TORREY Phase II imaging substudy.”

Seralutinib, a tyrosine kinase inhibitor targeting platelet-derived growth factor, colony-stimulating factor 1R, and c-KIT, is delivered via a dry powder inhaler designed for deep lung penetration. In the Phase II TORREY trial, this innovative therapy exhibited both clinical effectiveness and safety. The study successfully achieved its primary objective by reducing pulmonary vascular resistance, which is particularly noteworthy given the patients are heavily treated with standard-of-care medications.

In the TORREY FRI sub-study, innovative non-invasive CT imaging techniques from Fluidda, a pioneering medical technology company, were employed to assess seralutinib’s impact on blood vessel volume distribution within the pulmonary arteries. The results demonstrated a substantial increase in the BV510ARATIO, indicating a positive shift toward smaller vessels in the seralutinib-treated group after 24 weeks. These changes also correlated with improvements in stroke volume and pulmonary artery compliance.

Notably, a pre-planned subgroup analysis uncovered more substantial benefits among patients classified as functional Class III and those deemed at higher risk based on a REVEAL 2.0 score of 6 or higher.

Furthermore, the reduction in pulmonary vascular resistance, improvements in pulmonary function, and a decrease in NT-pro-BNP levels signify that seralutinib effectively alleviates right ventricular afterload, ultimately benefiting the right side of the heart.

The encouraging results from seralutinib’s clinical trials signify a significant advancement in combating the abnormal pulmonary vascular remodeling seen in PAH patients. These findings offer concrete evidence of seralutinib’s therapeutic potential in PAH treatment, particularly benefitting patients facing significant challenges in managing their condition. This multifaceted evidence strongly supports the concept of seralutinib’s efficacy in treating pulmonary arterial hypertension (PAH).

The study has laid a solid foundation for further exploration based on these promising results. A global Phase III program for PAH treatment is in the planning stages, with the anticipation that it will further substantiate seralutinib’s potential as a game-changing therapy for this challenging condition.

Market assessments conducted by DelveInsight in the Pulmonary Arterial Hypertension Market report indicate that the PAH market is projected to reach approximately USD 5,500 million by 2032 across the 7MM countries, highlighting the significant impact and potential of new treatments like seralutinib in improving the lives of PAH patients.