Biosergen AB ((DE:8N1)), Alkem Laboratories Ltd. ((IN:ALKEM)) announced an update on their ongoing clinical study.
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The recent clinical study update from Biosergen AB and Alkem Laboratories Ltd. focuses on assessing the safety and efficacy of intravenous BSG005 in patients with invasive fungal infections. Officially titled ‘A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection,’ the study aims to explore new treatment options for these challenging infections, which are significant due to their high morbidity and mortality rates.
The intervention being tested is BSG005, an experimental drug administered intravenously. This treatment is designed to combat invasive fungal infections by escalating doses to determine the optimal balance of safety and efficacy.
The study is interventional, with a single-group assignment and no masking, focusing primarily on treatment. Approximately 15 patients will be enrolled across three cohorts, each receiving escalating doses of BSG005 over a treatment period of up to 28 days, followed by a 14-day follow-up.
The study began on August 29, 2024, with the primary completion and estimated completion dates yet to be announced. The last update was submitted on April 3, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
This update could influence Biosergen AB and Alkem Laboratories Ltd.’s stock performance, as successful outcomes may boost investor confidence and market position, especially in the competitive pharmaceutical industry focused on antifungal treatments.
The study is currently recruiting, with further details available on the ClinicalTrials portal.