Centessa Pharmaceuticals PLC – ADR (NASDAQ: CNTA), in partnership with its subsidiary ApcinteX Limited announced that results from its ongoing first-in-human proof-of-concept study to analyze SerpinPC in severe hemophilia A and B patients are positive. This news automatically pushed the Pharma stock up by 20% on Thursday morning.
The study demonstrates that SerpinPC is well-tolerated
The patients were divided into two categories, namely those with hemophilia A and hemophilia B. About 23 subjects enrolled for the 24-week study period. All 22 patients who completed the study demonstrated that SerpinPC is well-tolerated. One of them did not continue to take SerpinPC, following an injection site reaction. However, no other adverse effects were reported as a result of administering the injection. In addition, it is learned that two of them had anti-drug antibodies, yet continued with the treatment and said no impact on annualized bleeding rates (ABRs).
Last 12-weeks of the study also known as the pre-specified primary assessment period
The study also reported that the injection brought down all bleeds ABR by 88% in the highest dose cohort. This specific finding was noticed in the last 12 weeks of treatment. Furthermore, it was reported that in the highest dose cohort, as many as five of the eight patients said no one bleeds during the same period. Additionally, self-reported joint bleeds ABR dropped by 94% in the highest dose cohort. The last 12-weeks of treatment are termed as the pre-specified primary assessment period.
All 22 patients who have completed the 24-week long Phase 2a part of the study have subsequently enrolled for the 48-week open-label extension (OLE) part. For this part of the study, the subjects will be administered a 60 mg subcutaneous dose of SerpinPC. The patients will be issued the injection once every four weeks for duration of 48-weeks. In this method, patients will receive a total of 13 doses. The company will make official results of the OLE part of the study in the second half of 2022.
Chief Medical Officer of Centessa Pharmaceuticals comments
Stating that the Pharma company is anxious about moving SerpinPC into a global development plan, Antoine Yver, M.D., M.Sc., Chief Medical Officer of Centessa Pharmaceuticals, said:
“The compelling reduction in bleeds and continued tolerability that we observed in both hemophilia A and hemophilia B patients in this proof-of-concept study are very encouraging, and we are eager to move SerpinPC into a global development plan aimed at pursuing one or more registrations. We see broad utility of SerpinPC across the hemophilia landscape and will seek the most rapid path to bring this potential subcutaneous therapy to hemophilia patients.”
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