Apellis Pharmaceuticals ((APLS)) announced an update on their ongoing clinical study.
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Apellis Pharmaceuticals is conducting a Phase 3 study titled ‘A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation.’ The study aims to assess the effectiveness and safety of Pegcetacoplan, a complement (C3) inhibitor, in preventing delayed graft function in patients undergoing kidney transplants. This research is significant as it could improve outcomes for patients with end-stage renal disease receiving deceased donor kidney transplants.
The intervention being tested is Pegcetacoplan, administered initially as a 20mL IV infusion, followed by subcutaneous infusions. It is designed to inhibit complement C3, potentially reducing the risk of delayed graft function.
The study is interventional, with participants randomly assigned to either the Pegcetacoplan or placebo group. It follows a parallel intervention model and employs triple masking, meaning the participant, care provider, and investigator are unaware of the group assignments. The primary purpose of the study is treatment-focused.
The study is not yet recruiting, with the initial submission date on June 6, 2025. The primary completion and estimated completion dates are yet to be announced. The last update was also on June 6, 2025, indicating the study is in its early stages.
This study could significantly impact Apellis Pharmaceuticals’ stock performance and investor sentiment, as successful results may enhance the company’s position in the renal disease treatment market. Competitors in the kidney transplant space will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.