Basilea Pharmaceutica Ltd, a biopharmaceutical company based in Allschwil, Switzerland, has recently announced the launch of the Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC) phase 3 study. This study aims to evaluate the effectiveness and safety of their antifungal fosmanogepix in treating adult patients with candidemia and/or invasive candidiasis, which are serious infections caused by Candida yeast in the bloodstream or deep-seated tissues.
Fosmanogepix is a unique antifungal treatment with a new mechanism of action. It comes in both intravenous and oral forms and has undergone testing in phase 1 and phase 2 trials, including studies focusing on Candidemia and invasive mold infections. Dr. Marc Engelhardt, the Chief Medical Officer of Basilea, expressed excitement about the initiation of the phase 3 study and emphasized the urgent need for new treatment options for invasive Candida infections, which can be life-threatening and have high mortality rates.
The FAST-IC study is a global endeavor involving multiple centers worldwide. It is a randomized, double-blind trial comparing intravenous fosmanogepix to a standard-of-care regimen of intravenous caspofungin in adult patients with candidemia and/or invasive candidiasis. Approximately 450 patients will participate in the study, with a 2:1 randomization to receive either fosmanogepix or caspofungin. Patients in the fosmanogepix group may have the option to switch to oral fosmanogepix, while those in the caspofungin group may switch to fluconazole.
Basilea obtained the rights to fosmanogepix from Amplyx Pharmaceuticals, Inc. in November 2023. The company will fulfill its obligations under the asset purchase agreement, including a milestone payment of USD 6.0 million upon the enrollment of the first patient. This financial commitment is reflected in Basilea’s guidance for the full year 2024.
Fosmanogepix has garnered attention for its broad-spectrum antifungal properties and its efficacy against various strains of Candida and Aspergillus, including drug-resistant strains like Candida auris. It has received Fast Track and Orphan Drug designations from the US FDA for multiple indications and is designated as a Qualified Infectious Disease Product (QIDP).
Invasive mold infections, such as invasive aspergillosis and infections caused by rare molds like Fusarium and Scedosporium species, pose significant risks to immunocompromised patients. Similarly, invasive candidiasis, including candidemia and deep-seated tissue infections, is a critical concern in hospital settings, with high mortality rates even with antifungal treatment.
Basilea, founded in 2000 and headquartered in Switzerland, is dedicated to developing innovative drugs for severe bacterial and fungal infections. Their current portfolio includes hospital brands like Cresemba and Zevtera for fungal and bacterial infections, respectively. The company is listed on the SIX Swiss Exchange.
As with any medical advancement, there are risks and uncertainties associated with the development and testing of new treatments. Basilea acknowledges these challenges and remains committed to providing updates on their progress. For more information, individuals can contact Peer Nils Schröder, the Head of Corporate Communications & Investor Relations at Basilea Pharmaceutica International Ltd.
In conclusion, the initiation of the phase 3 study for fosmanogepix marks a significant step forward in addressing the urgent need for effective treatments for invasive fungal infections. The global effort to evaluate the safety and efficacy of fosmanogepix underscores the commitment of Basilea Pharmaceutica Ltd to improving patient outcomes in the face of these life-threatening conditions.
