Equity Research Biosergen: Study permission received, BSG005 ready for testing in patients

On 11 June, Biosergen and partner Alkem Laboratories received permission to test BSG005 as a rescue therapy in patients with invasive fungal infections. While this is three months later than previously targeted, measures are being taken to mitigate the delay.

CDSCO grants import license for BSG005, phase Ib study incipient

Biosergen was intended to initiate the phase Ib trial in India in March of this year. However, this has been delayed due to red tape associated with an import license required to ship BSG005 into India. On 11 June, this was finally granted by the Central Drugs Standard Control Organization (CDSCO). To give the delay some context, India is known to be on the bureaucratic side when it comes to regulatory and compliance. Thus, the delay is not wholly unexpected, and it can be the case that it would have been more severe had Biosergen not had the partnership with Alkem. Furthermore, to alleviate the delay and keep the timeline intact, Biosergen and Alkem have doubled the number of sites used for recruitment and added more backup sites.

The study will include 15 patients suffering from severe fungal infections, including mucormycosis (black fungus), aspergillosis, and candidiasis. The targeted patient population will consist of patients who are intolerant of Amphotericin B and have failed first-line therapies, as well as patients with mild to moderate kidney impairment, a factor that contributes to the intolerability of Amphotericin B. The study will be a single-arm, multi-centre, open-label, dose-escalation study to assess safety and efficacy.

Taken together, we are pleased to see that BSG005 is finally ready to reach patients in need in India. Given the safety-and-tolerability profile demonstrated in the previous phase Ia trial in healthy volunteers, most notably the little to no impact on kidney or liver parameters, we recognize the potential for BSG005 in this patient population. We are positively encouraged by the inclusion of twice the amount of sites. Should the study show promising results, we expect that it can be expanded to a phase IIb study and involve more patients at earlier stages. This will result in a cost-effective route toward approval in India as well as in other geographies.

We expect to release a research update taking the latest developments into account in the coming weeks.
Read our latest Research update here.

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