Pfizer reports Phase 3 THRIVE-131 study in SCD did not meet primary endpoint

Pfizer (PFE) announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigational P-selectin inhibitor, in patients 16 years of age and older with sickle cell disease. The study did not meet its primary endpoint of significant reduction in the rate of vaso-occlusive crises in participants receiving inclacumab versus placebo every 12 weeks over 48 weeks. Inclacumab was generally well tolerated in THRIVE-131. The most commonly reported treatment-emergent adverse events in either group were anemia, arthralgia, back pain, headache, malaria, sickle cell anemia with crisis, and upper respiratory tract infection. Analyses of the data will be shared with the scientific and patient community in due course, the company stated. “We recognize this news is disappointing for the sickle cell community, and we share their disappointment. While the THRIVE-131 results did not meet our expectations, we remain committed to better understanding these results and sharing them with the medical and sickle cell community in the interest of advancing our collective understanding of sickle cell disease. We remain focused on our mission of bringing much-needed treatments to patients with sickle cell disease. We are deeply grateful to the participants and investigators for their contributions to this important work. Their efforts are invaluable in informing future sickle cell research,” said Michael Vincent, M.D., Ph.D., Chief Inflammation & Immunology Officer, Pfizer. “Pfizer remains committed to the sickle cell community and is actively progressing next steps for its broader SCD portfolio, including Oxbryta and osivelotor. Updates on Oxbryta and osivelotor will be provided as they become available,” the company added.