Biosergen Completes Enrollment of First Cohort in BSG005 Proof-of-Concept Trial
October 7, 2024 – Biosergen AB (“Biosergen”), a clinical-stage biotechnology company developing therapies for life-threatening fungal diseases, today announced the successful enrollment of the first five-patient cohort in its proof-of-concept clinical trial. The trial is evaluating the company’s drug candidate, BSG005, as a rescue therapy for patients who have failed previous standard-of-care antifungal treatments due to either lack of efficacy or safety or patients with mild to moderate kidney impairment.
“We are thrilled to have filled the first cohort,” said Tine Olesen, CEO of Biosergen. “This underscores the substantial unmet need for a rescue treatment in patients who, for a variety of reasons, don’t respond to, or are not suitable for, treatment with existing therapies, and we are very grateful to our partners at Alkem Laboratories Ltd. and the investigators for making this possible. We are taking the first steps in a process, which could prove to be transformative for patients suffering from multiple types of severe fungal infections, including those caused by the aspergillus fungi—a growing challenge for healthcare systems worldwide.”
All five patients are either receiving active treatment without severe side effects, or have completed treatment, marking a critical advancement in the development of this potentially life-saving therapy. Four of the five patients are currently in an early stage of dose escalation, where daily doses of BSG005 increase by 0.1 mg/kg every third day. Of these four patients, 3 are suffering from aspergillosis, and 1 are suffering from mucormycosis.
It is estimated that 2.1 million people develop invasive aspergillosis each year with a crude annual mortality of 1.8 million, making it a highly life-threatening condition. Biosergen holds an orphan drug designation for BSG005 from the U.S. Food and Drug Administration (FDA) for treating aspergillosis, emphasizing the FDA’s prioritization of new treatments for this condition.
In addition to the four patients currently receiving BSG005, a fifth patient has completed the 28-day treatment cycle, as reported by Biosergen on August 30. This case is a notable example of how BSG005 could potentially transform the lives of patients at severe risk from fungal infections. The patient, a 47-year-old male diagnosed with mucormycosis (black fungus), was initially scheduled for surgical removal of one of his infected lungs. However, following treatment with BSG005, the patient made a remarkable recovery, resulting in the cancellation of the surgery. He retained both lungs and is now in a follow-up monitoring period.
The ongoing proof-of-concept trial aims to enroll up to 15 patients by January 2025, to assess the safety, tolerability, and efficacy of BSG005. Biosergen’s corporate partner, Alkem Laboratories , a leading Indian pharmaceutical company with clinical development expertise and an established commercial infrastructure, 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.