Pfizer Inc. (NYSE:PFE) on Friday released 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.
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Sickle cell disease is a group of inherited red blood cell disorders that affects hemoglobin, the protein that carries oxygen. It causes red blood cells to become rigid and sickle-shaped, leading to blocked blood flow, pain and organ damage.
The study did not meet its primary endpoint of a significant reduction in the rate of vaso-occlusive crises (VOCs) 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.
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Pfizer said it is actively progressing next steps for its broader sickle cell disease portfolio, including Oxbryta (voxelotor) and osivelotor. Updates on Oxbryta and osivelotor will be provided as they become available.
In September 2024, Pfizer withdrew all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease in all markets where it is approved.
Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.
The decision is based on the totality of clinical data indicating that the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.
What Other Pharmaceutical Companies Are Doing
Earlier this year, IMMvention Therapeutix Inc. announced a strategic collaboration and license agreement with Novo Nordisk A/S (NYSE:NVO) to co-develop oral therapies for sickle cell disease and other chronic conditions.
The partnership will leverage IMMvention’s investigational small-molecule BACH1 inhibitors.
In December 2024, Beam Therapeutics Inc. (NASDAQ:BEAM) revealed new safety and efficacy data from its BEACON Phase 1/2 trial of BEAM-101 in patients with sickle cell disease with severe vaso-occlusive crises (VOCs).
Consistent with Beam's previously announced data, updated data from seven patients treated with investigational base-editing therapy BEAM-101 demonstrated robust and durable increases in fetal hemoglobin (HbF) and reductions in sickle hemoglobin (HbS), rapid neutrophil and platelet engraftment, and normalized or improved markers of hemolysis.
PFE Price Action: Pfizer stock is up 0.24%% at $25.17 at publication on Friday.
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