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Pfizer's inclacumab fails Phase III study for sickle cell disease, disappointing the community while the company remains committed to future treatments.
Inclacumab did not complete its primary endpoint of reducing the rate of VOCs in patients administered with inclacumab during its Phase III study.
Pfizer announced the results from the Phase III Thrive-131 study that evaluated the investigational P-selectin inhibitor, inclacumab. The study, conducted with patients 16-years-and-older suffering from sickle cell disease (SCD), resulted in inclacumab not reaching its primary endpoint of significant reduction in the rate of vaso-occlusive crises (VOCs) in participants who received inclacumab.
Michael Vincent, M.D., Ph.D., chief inflammation & immunology officer at Pfizer, touched on the disappointment of the failed study, saying, “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.”1
Inclacumab’s failure in its Phase III study is now the second drug from Pfizer’s acquisition of Global Blood Therapeutics. Back in 2022, Pfizer acquired Global Blood therapeutics in a $5.4 billion buyout, with Obryta headlining the purchase. Obryta was withdrawn from the market in September of last year, and now with inclacumab failing its Phase III study, the acquisition’s outlook shifted.
BMO Capital Markets analyst Evan Seigerman touched on the impact of the inclacumab’s short comings following Obryta’s disappointment, saying, "Pfizer's acquisition of Global Blood has proven disappointing with inclacumab's failure coming after Oxbryta's 2024 withdrawal from all approved markets"2
The Phase III Thrive-131 study was conducted over a 48-week period, as a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of inclacumab, an investigational monoclonal antibody targeting P-selectin as a treatment option for SCD. The study enrolled 241 participant’s aged 16-years-and-older with SCD who reported between two-to-ten VOCs within the last year. Participants were selected at random to receive either inclacumab or the placebo every 12 weeks for the during of the study.
The trials primary endpoint measured the rate of VOCs in patients receiving inclacumab compared to those receiving the placebo with the end results yielding no significant difference in VOC rates in participant’s receiving inclacumab compared to the those receiving the placebo.
Despite inclacumab’s short comings, Pfizer remains committed to patients suffering from sickle cell disease and will continue to pursue the next steps in expanding its SCD treatment portfolio, including Oxbryta and osivelotor.
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