Pfizer sticks by timeline for sickle cell drug despite axing study over slow enrolment
2024-03-27
并购临床3期临床2期
Pfizer confirmed Wednesday that the termination of a Phase III study in the THRIVE programme for inclacumab will not affect its filing plans for the anti-P-selectin inhibitorP-selectin inhibitor in sickle cell disease. A spokesperson told FirstWord that a marketing submission to the FDA remains on track for 2026.
A recent update on ClinicalTrials.gov indicated that Pfizer had ended the trial “due to poor accrual and associated recruitment challenges.” The entry noted that 72 patients with sickle cell disease and recurrent vaso-occlusive crises had been enrolled into the study, out of a target of approximately 280.
The spokesperson said the trial was halted “due to slow recruitment,” although it has no read across to another late-stage study in the THRIVE programme. That trial is scheduled to read-out in August.
Pfizer gained inclacumab through its purchase of Global Blood Therapeutics in 2022. The acquisition also included the HbS polymerisation inhibitor GBT601, now known as PF-07940367. That drug is being investigated in a Phase II/III study for sickle cell disease, with the spokesperson noting that termination of the inclacumab trial does not impact the former programme.
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