Pfizer has terminated one of its two phase 3 trials evaluating inclacumab, a monoclonal antibody aimed at treating sickle cell disease, due to slow recruitment. The THRIVE trials, part of a program initiated to assess inclacumab's safety and efficacy in reducing vaso-occlusive crises, faced challenges with poor accrual, resulting in only 72 out of an expected 280 patients being enrolled before the study concluded in November 2023.
Despite the setback, Pfizer remains determined to secure market approval for inclacumab by 2026. The company's spokesperson emphasized that the termination does not affect its plans for potential FDA approval, as inclacumab has already received orphan and rare pediatric disease designations from the agency for sickle cell disease. Pfizer's portfolio in the sickle cell space includes three assets acquired from Global Blood Therapeutics, with inclacumab being one of them. While the trial discontinuation does not impact the midstage program, Pfizer's commitment to advancing treatment options for sickle cell disease remains steadfast amidst evolving developments in the field, including recent approvals such as Vertex Pharmaceuticals' and CRISPR Therapeutics' Casgevy gene therapy.
