Apellis Pharmaceuticals Inc (NASDAQ:APLS) recently its Phase 3 PEGASUS study results, where pegcetacoplan provides better results than eculizumab in combatting nocturnal hemoglobinuria (PNH).
The Phase 3 PEGASUS study data showed that pegcetacoplan efficient than eculizumab in boosting paroxysmal nocturnal hemoglobinuria (PNH) patients’ hemoglobin levels. The data also indicated that pegcetacoplan provided more consistent results throughout the patient population involved in the clinical study. The results were also consistent in patients that had to be transfused, as well as those that were not transfused during the 12-month study.
Pegcetacoplan also achieved strong responses in numerous key data-points that measure PNH. Apellis also revealed that the treatment also achieved the primary endpoints used to measure efficacy in the study. The company expressed excitement in the findings.
“The PEGASUS results showed that pegcetacoplan, our targeted C3 therapy, demonstrated substantial improvement over C5 inhibition in PNH,” stated Apellis Chief Medical Officer, Federico Grossi.
Mr. Grossi further added that the study’s data further reinforces pegcetacoplan’s ability to improve the health and standard of life for patients suffering from PNH. He also added that the company is in talks with regulatory authorities to speed up the regulatory processes that will allow the treatment to be available to patients as fast as possible.
The company will submit the findings of the study to the European Medicines Agency to apply for a Marketing Authorization Agreement (MAA). It will also file for a New Drug Application (NDA) from the U.S. Food and Drug Administration. The filings will help speed up the regulatory review process as part of Apellis’ plan to make the treatment available in the market as soon as possible.
According to the Phase 3 PEGASUS study results, Pegcetacoplan demonstrated the ability to achieve higher normalization rates in hemolysis markers. It also scored higher than eculizumab in the FACIT-fatigue score by the 16th week of the study. Pegcetacoplan is expected to be a favorite for PNH patients because it does not require them to be transfused regularly.