Pfizer fails in late-stage trial for sickle cell disease therapy

Pfizer (NYSE:PFE) announced Friday that a late-stage clinical trial for inclacumab, its experimental therapy for the blood disorder sickle cell disease, did not meet the main goal, marking the latest setback for its SCD portfolio.

Citing data from its Phase 3 THRIVE-131 study, the New York-based pharma giant stated that the trial didn’t reach the primary endpoint related to the reduction in the incidence of vaso-occlusive crises in patients treated with inclacumab compared to those on placebo.

However, the P-selectin inhibitor was well tolerated among trial participants who were 16 years and older, the company noted, adding that anemia, arthralgia, and back pain were among the most commonly reported treatment-emergent adverse events.

Pfizer’s (NYSE:PFE) SCD portfolio includes its Phase 3 asset, osivelotor and Oxbryta (voxelotor), which was added through its $5.4B acquisition of Global Blood Therapeutics in 2022. Last year, the company pulled Oxbryta from global markets, citing safety concerns.

Meanwhile, the FDA has imposed a partial clinical hold related to enrollments in a Phase 3 trial designed to test osivelotor in SCD.