[ad_1]
Pictured: Exterior view of Pfizer’s Belgium office/iStock, Alexandros Michailidis
Pfizer has halted one of its two Phase III studies evaluating the anti-P-selective antibody inclacumab in sickle cell disease, according to an update on the ClinicalTrials.gov web page.
Pfizer terminated the late-stage study “due to poor accrual and related recruitment challenges,” according to an online database. The trial starts in December 2021. However, as of Monday’s update, the study had only enrolled 78 patients, out of a target size of 280 participants.
A Pfizer spokesperson confirmed Fierce Biotech The company ended the study “due to slow recruitment,” while adding that the drugmaker still plans to approve inclacumab to treat sickle cell disease by 2026.
Inclacumab, originally developed by Global Blood Therapeutics (GBT), is a fully human monoclonal antibody that works by selectively blocking P-selectin protein, which is known to play a role in cell adhesion. Clinically proven target for reducing vascular-related pain – occlusive crisis (VOC) in patients with sickle cell disease (SCD).
Inclacumab received Orphan Drug and Rare Pediatric Disease designation from the FDA in June 2022 for the treatment of SCD due to its best-in-class potential and its quarterly dosing regimen rather than monthly infusions.
In August 2022, Pfizer acquired GBT for $5.4 billion, acquiring the biotech’s portfolio of SCD therapies, which includes FDA-approved Oxbryta (voxelotor), an oral hemoglobin S polymerization inhibitor for four-year-olds and above patients. Inclacumab was also part of the acquisition.
Following the acquisition, Pfizer took over the Phase III THRIVE program, which consisted of two studies (including the subsequently terminated trial) designed to evaluate the efficacy and safety of inclacumab in reducing VOCs in patients with SCD. Another trial is ongoing and has completed enrollment of 240 patients. Results are expected later this year, according to its ClinicalTrials.gov page.
Pfizer’s termination of late-stage studies follows a string of landmark approvals in SCD. In December 2023, the FDA approved CRISPR Therapeutics and Vertex Pharmaceuticals’ CRISPR-based Casgevy (exagamglogene autotemcel) and bluebird bio’s lentiviral delivery-based Lyfgenia (lovotibeglogene autotemcel) on the same day.
Casgevy and Lyfgenia are cell-based gene therapies. Both products are made from the patient’s own blood stem cells, modified and returned as a one-time, single-dose infusion. Casgevy is priced at $2.2 million per patient in the U.S., while Bluebird puts Lyfgenia’s U.S. wholesale purchase cost at $3.1 million.
In January 2024, the Centers for Medicare and Medicaid Services announced that it would pursue outcomes-based agreements with developers of these SCD gene therapies to help control health care costs.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Please contact him on LinkedIn or email tristan@tristanmanalac.com or tristan.manalac@biospace.com.
[ad_2]
Source link