Pfizer’s sickle cell disease candidate fails Phase III trial

Inclacumab was generally well tolerated in THRIVE-131

Inclacumab, Pfizer’s candidate sickle cell antibody therapeutic, has failed to reach its primary endpoint in a Phase III trial called THRIVE-131.

“We recognize this news is disappointing for the sickle cell community, and we share their disappointment,” said Michael Vincent, MD, PhD, chief inflammation & immunology officer, Pfizer, in a press statement about the trial results.

Inclacumab was generally well tolerated in THRIVE-131. The most commonly reported treatment-emergent adverse events in both the inclacumab and placebo groups included anemia, arthralgia, back pain, headache, malaria, sickle cell anemia with crisis, and upper respiratory tract infection.

“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.”

Pfizer stated that analyses of the THRIVE-131 data will be shared with the scientific and patient community in due course.