With Pfizer having recently scored an approval for its tissue factor pathway inhibitor Hympavzi, Centessa Pharmaceuticals has decided that taking its own hemophilia B contender to market is not worth the effort.
Centessa had recently conducted an interim analysis of a phase 2 study of its drug, called SerpinPC, which is designed to inhibit activated protein C. The analysis had demonstrated that SerpinPC had a favorable safety and tolerability profile, the U.K. and U.S.-based biotech said in its third-quarter earnings release.
However, rather than push ahead to phase 3, Centessa said it had made “a strategic and data-driven decision to discontinue the global clinical development of SerpinPC.”
“The company determined that additional time and investment would be required to further develop SerpinPC with a more competitive profile for the treatment of hemophilia B in light of the evolving treatment and market landscape for hemophilia B, including the recent FDA approval of a competing product,” Centessa explained in the release.
It's true that the hemophilia B space suddenly got a whole lot more crowded this year, courtesy of two big regulatory wins for Pfizer. First, the Big Pharma scored an FDA approval for its hemophilia B gene therapy Beqvez. But of greater concern for Centessa was the approval granted last month to Hympavzi, Pfizer’s anti-tissue factor pathway inhibitor, for patients aged 12 and older with hemophilia A or B who have not developed antibodies to previous inhibitor treatments.
Pfizer had been able to leapfrog to the front of the hemophilia B race after the FDA rejected an application for Novo Nordisk’s TFPI monoclonal antibody concizumab last year over dosing and manufacturing issues.
Only a few months ago, Centessa execs had still been touting the potential for SerpinPC to become a “first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B.” With the approval of Hympavzi, those dreams appear to have died.
Canning the plans to commercially launch SerpinPC frees up about $200 million from Centessa’s budget, which the biotech will divert to its orexin receptor 2 (OX2R) agonist franchise. This program is headed up by ORX750, a narcolepsy-focused candidate that is undergoing a phase 1 trial in acutely sleep-deprived healthy volunteers. A phase 2 study in narcolepsy type 1 and type 2 as well as in idiopathic hypersomnia has also kicked off with a readout pencilled in for next year.
The biotech’s only other remaining clinical-stage candidate is LB101, a PD-L1xCD47 bispecific monoclonal antibody in a phase 1/2a study for solid tumors.
“With a cash runway that extends into mid-2027, we believe Centessa is well positioned to support our OX2R agonist franchise through multiple, potential value-creating milestones,” the company’s CFO John Crowley said in the release.
Today is not the first time that Centessa has stripped back its pipeline. Back in 2022, the company culled two clinical-stage candidates in quick succession over reports of elevated liver enzymes.