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Equity research Biosergen: Plans for speedy development of lead candidate

29 mar 2023

Equity Research Biosergen

Biosergen has outlined its plans for the next step in clinical development for BSG005. Biosergen aims to initiate the first trial in patients  towards the end of Q2, provided the clinical trial application is approved. The trial will be conducted at a single centre in India and will include  patients with invasive fungal infections. Expected diseases range from mucormycosis, colloquially referred to as black fungus, aspergillosis and at a later stage febrile, neutropenic patients with symptoms of invasive fungal infection. One inclusion criterion will be intolerability to previous treatment with Amphotericin B, which has the same active substance as BSG005. The aim is to identify the best indication for further development of BSG005 and gain additional information on optimal dosing and treatment cycles.

While the initial Phase II study is small (around 15 patients), it could provide an early proof of concept in relevant patient groups that currently have very limited treatment options. The top-line Phase I data importantly indicated no signs of kidney or liver toxicity in healthy volunteers. The safety results should bode well for tolerability in patients. Top-line data for the first Phase II study is expected approximately six months after the dosing of the first patient. We interpret this as the beginning of next year.

The Phase IIa study outlined above is on the smaller side, and consequently, the implied timeline is also somewhat shorter than we have previously assumed. Thus, there is room for a positive deviation from our cost estimates if Biosergen can successfully conclude the study in a limited sample.

Read our Initiation of coverage report on Biosergen (20 March) (base case fair value per share SEK 4.3 per share).


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Equity research Biosergen: Plans for speedy development of lead candidate