Basilea Pharmaceutica ((CH:BSLN)) announced an update on their ongoing clinical study.
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Basilea Pharmaceutica is conducting a Phase 3 clinical study titled An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis. The study aims to evaluate the safety and efficacy of Fosmanogepix in treating candidemia and invasive candidiasis, serious fungal infections caused by Candida species. This research is significant as it seeks to demonstrate that Fosmanogepix is not inferior to the existing treatment regimen of caspofungin followed by fluconazole.
The study tests Fosmanogepix, administered initially as an intravenous infusion with an option to switch to oral tablets, against a standard treatment of caspofungin IV followed by oral fluconazole. Fosmanogepix is being investigated for its potential to provide an effective alternative treatment for these life-threatening infections.
This randomized, double-blind study uses a parallel intervention model with quadruple masking, involving participants, care providers, investigators, and outcomes assessors. The primary purpose is treatment, focusing on the comparative effectiveness of the interventions.
The study began on June 7, 2022, with an estimated completion date in 2025. The most recent update was submitted on August 11, 2025. These dates are crucial for tracking the study’s progress and anticipating results that could influence treatment protocols.
The outcome of this study could significantly impact Basilea Pharmaceutica’s stock performance and investor sentiment, particularly if Fosmanogepix proves to be a viable alternative to current treatments. This could position Basilea favorably in the antifungal market, potentially affecting competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.