Update on BSG005 Phase Ib Study: CDSCO grants import license

Biosergen and Alkem Laboratories have received permission to test BSG005 as a rescue therapy for patients with invasive fungal infections. The delay in starting the phase Ib trial in India was due to the red tape associated with obtaining an import license for BSG005. However, on 11 June, the Central Drugs Standard Control Organization (CDSCO) granted the import license, allowing the study to move forward.

The study will include 15 patients with severe fungal infections, such as mucormycosis, aspergillosis, and candidiasis. These patients will be intolerant of Amphotericin B and have failed first-line therapies, as well as have mild to moderate kidney impairment. The trial will be a single-arm, multi-center, open-label, dose-escalation study to assess safety and efficacy.

With the promising safety-and-tolerability profile demonstrated in the previous phase Ia trial in healthy volunteers, there is potential for BSG005 to help patients in need. The inclusion of more recruitment sites and backup sites aims to mitigate the delay and keep the timeline intact. If the study shows positive results, it may lead to a phase IIb study with more patients at earlier stages, paving the way for approval in India and other regions.

Stay tuned for a research update in the coming weeks to learn more about the latest developments in this exciting study.