Gossamer bio took a few steps forward in December when a high blood pressure med passed a phase 2 trial. But now, the biotech is taking a couple steps back with news that enrollment is being paused for its second clinical-stage asset due in part to the med’s risk-benefit profile.
The company is halting enrollment of GB5121, a treatment for primary central nervous system lymphoma currently in phase 1 trials, citing the “benefit/risk profile observed to date,” according to a Friday earnings report. Gossamer said it was also making this move to conserve cash that could be better directed toward lead asset seralutinib.
Gossamer did not immediately respond to a request for additional details on the safety profile of the drug. The company plans to review the available data with the study’s data review committee to chart next steps, according to the earnings report.
The news puts one of Gossamer's two clinical-stage assets into limbo. The global phase 1/2 stage trial has been ongoing for roughly 10 months, with recruitment beginning in May. The study was recruiting from the U.S., France, Australia, Israel and New Zealand. The company aimed to recruit 158 patients according to the clinical trial record. It’s unclear how many patients have been recruited to date.
The decision also places added emphasis on seralutinib, a treatment for pulmonary arterial hypertension that passed a phase 2 test in December. Gossamer reported that treated patients had a 14.3% improvement in a measure of blood flow, passing the main goal. But seralutinib faces stiff competition, namely Merck’s sotatercept which produced much stronger data and has a leg up in the clinical race. Merck CMO Eliav Barr told Fierce Biotech that the expectation is to launch sotatercept in early 2024, while seralutinib is expected to land in a phase 3 trial in the second half of 2023.
Gossamer reported having $255.7 million in cash and investments, enough to last into the second half of 2024, according to the earnings report.