Biosergen AB has announced the successful enrollment of the first five-patient cohort in its proof-of-concept clinical trial evaluating BSG005 as a rescue therapy for patients with life-threatening fungal diseases. This trial targets individuals who have not responded to or cannot tolerate existing antifungal treatments, including those with mild to moderate kidney impairment.
Tine Olesen, CEO of Biosergen, emphasized the critical need for new treatments, particularly for infections caused by Aspergillus fungi, which pose a growing challenge to healthcare systems globally. The trial represents a significant step toward potentially transforming the treatment landscape for severe fungal infections.
Early Treatment Outcomes
Four of the five patients are currently undergoing dose escalation, with daily doses of BSG005 increasing by 0.1 mg/kg every three days. Among these patients, three are suffering from aspergillosis, and one from mucormycosis. A fifth patient has completed the 28-day treatment cycle. Notably, this patient, a 47-year-old male with mucormycosis, was initially scheduled for lung removal surgery. Following BSG005 treatment, the patient experienced a significant recovery, leading to the cancellation of the surgery and retention of both lungs. The patient is now in a follow-up monitoring period.
Trial Design and Objectives
The ongoing proof-of-concept trial aims to enroll up to 15 patients by January 2025. The primary objectives are to assess the safety, tolerability, and efficacy of BSG005. Biosergen's corporate partner, Alkem Laboratories, will finance and conduct subsequent Phase 2 and 3 trials in India, contingent on the successful completion of the current trial. Biosergen retains all commercial rights for BSG005 outside of India.
Disease Burden and Regulatory Status
It is estimated that 2.1 million people develop invasive aspergillosis each year, with a crude annual mortality of 1.8 million. BSG005 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for treating aspergillosis, highlighting the urgent need for new treatments for this condition.
