Feb 23 (Reuters) – Gossamer Bio’s experimental drug has missed the main goal of a late-stage study in patients with a serious lung and heart condition, the drug developer said on Monday.
The drug, seralutinib, is being developed for pulmonary arterial hypertension, in which high blood pressure builds up in the lung arteries as the vessels narrow or become damaged, forcing the right side of the heart to work harder, potentially leading to heart failure.
In the 24-week study, patients taking seralutinib improved their walking distance by a median of 28.2 meters, compared to 13.5 meters for those on placebo.
But the difference did not meet the study’s threshold for statistical significance.
“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 CEO Faheem Hasnain.
Gossamer is developing seralutinib with Italy‑based Chiesi Group under a global collaboration agreement.
(Reporting by Sahil Pandey and Siddhi Mahatole in Bengaluru; Editing by Sahal Muhammed)
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