Biosergen

"We are encouraged by the Safety Review Committee's positive review of BSG005's safety profile in the initial cohort, and we look forward to evaluating the effects of dose escalation in the next group of patients," said Tine Olesen, CEO of Biosergen. "This decision marks an important step in our clinical program, and we are pleased to continue our proof-of-concept trial as planned, remaining on track to enroll and treat three cohorts by January 2025."

The current proof-of-concept trial assesses BSG005's safety, tolerability, and efficacy as a rescue therapy for patients with potentially life-threatening fungal infections who have limited or no treatment options. The initial cohort, treated at a lower dose, demonstrated promising outcomes with no significant safety concerns reported. This led to longer treatments and higher doses than first anticipated, underscoring the clinical investigators' emerging confidence in BSG005's safety and promising efficacy even at this early stage. Based on this data, the committee has approved the initiation of the second cohort.

In the first cohort, the daily dose was gradually escalated from 0.1 mg/kg to a maximum of 0.8-1 mg/kg, as, in two cases, patients felt well enough to independently opt to leave the hospital before reaching 1 mg/kg. For the second cohort, it is planned to escalate the dosing from 0.8 mg/kg to 1.5mg/kg, dependent on safety and efficacy data of the individual patient.