Biosergen AB announced that it has received permission to test BSG005 as rescue therapy in patients with invasive fungal infections. The Company?s partner, Alkem Laboratories Limited (Alkem), has received an approval of the Clinical Trial Application from the Central Drugs Standard Control Organization (CDSCO) in India. The approval allows for the initiation of the first patient study for BSG005 in a clinical trial designed to address unmet medical needs in invasive fungal infections.

Biosergen and Alkem will enrol 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. Finally, also patients with mild to moderate kidney impairment can be enrolled.

These populations urgently require an alternative treatment option, as currently, no effective alternatives are available. The primary objective of this patient trial is to evaluate the potential of BSG005 as a rescue treatment based 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 next step is to receive Ethics Committee approval and first patient first visit is expected in March 2024.