Alkem Laboratories Limited has submitted a Clinical Trial Application to the Central Drugs Standard Control Organization (CDSCO) in India. The application pertains to the initiation of the first patient study for BSG005, Biosergen?s leading antifungal drug candidate, a clinical trial designed to address unmet medical needs in invasive fungal infections. This application follows the licensing and co-development agreement between Biosergen and Alkem, which was announced on September 25, 2023.

Under this agreement, Alkem and the CRO will enroll patients suffering from severe fungal infections, including mucormycosis (Black Fungus), aspergillosis, and candidiasis. The trial focuses on patient populations intolerant or resistant to Amphotericin B, the current last-resort treatment for severe invasive fungal diseases, as well as those who have experienced treatment failure with first-line therapy. Additionally, patients with mild to moderate kidney impairment, for whom Amphotericin B treatment is not feasible, will be included.

These populations urgently require an alternative treatment option, as currently, no effective alternatives are available. Building on the promising safety and efficacy profile demonstrated in preclinical studies of BSG005 and the results of the Phase 1 trial, which showed the absence of severe side effects, the primary objective of this patient study trial is to evaluate the potential of BSG005 as a rescue treatment for these patients. The submission of the Clinical Trial Application in India, known as a Clinical Trial-1 application, is equivalent to what is referred to as an Investigational New Drug (IND) application in other countries.

The Alkem medical and regulatory team, together with the Biosergen team, has made an effort and included two more sites and a new local CRO to make this study run smoothly. This is a major successful effort in this cooperation.