Fungal infections, particularly multidrug-resistant strains, are a growing global concern, flagged by the World Health Organization as top-priority threats. Meanwhile, current antifungal drugs, developed decades ago, struggle to keep up while fungi continue to evolve resistance.
BSG005 offers a potential solution to combat these life-threatening infections. To overcome resistant strains and fill gaps in our armamentarium, Biosergen has aligned with this call for innovation. Read more here.
A next-generation antifungal
At the heart of Biosergen’s pipeline is BSG005, a next-generation polyene antifungal designed to save critically ill patients when standard treatments fail. Unlike azoles and echinocandins, which are fungistatic, BSG005 is fungicidal, killing fungal cells, including resistant strains like Candida auris, as shown in preclinical studies.
In the ongoing trial in India, all eight patients completing treatment across two cohorts showed clinical benefits. Two achieved complete recovery, six showed significant improvement, and none reported severe side effects, even among those with kidney impairment or intolerance to Amphotericin B.
Clinical and regulatory momentum
In February, Biosergen completed the second cohort, with eight of ten patients showing clinical improvement, reinforcing BSG005’s potential, as noted by CEO Tine Olesen in the Q1-report. These results drive Biosergen’s next step – a third cohort in Q4 2025, delayed slightly due to higher dosing requirements. In partnership with Alkem Laboratories, Biosergen is manufacturing a new GMP-compliant batch of BSG005 to support this cohort and future global trials, ensuring compliance with agencies like the FDA and EMA.
Biosergen is advancing regulatory discussions with India’s CDSCO to plan a phase II trial and with the U.S. FDA for a pre-IND meeting, a critical step toward U.S. trials. In collaboration with Alkem, Biosergen is designing a global phase II/III adaptive trial for aspergillosis, targeting 150 patients.
Strengthening the board
Recently, Biosergen proposed the election of Dr. Marco Taglietti to its Board of Directors, having led successful clinical programs and secured major regulatory approvals. With a proven track record in licensing and partnerships, his insight is expected to support the company’s ambition to scale internationally. Read more here.
Financial situation
Looking at the financials, Biosergen ended Q1 2025 with a cash position of SEK 44.8 million. The operating loss for the quarter was SEK 5.1 million, an improvement from SEK 6.9 million in Q1 2024, reflecting continued investment in R&D.
Comments from the CEO
Looking ahead, with clinical, regulatory, and manufacturing efforts converging, 2025 could be a transformative year for Biosergen. We reached out to Tine Olesen, the company’s CEO, for a comment.
How would you describe the clinical significance of the results from cohort two?
– It makes me truly happy to see that patients that have failed standard of care gets another chance with BSG005 and we can improve their situation. It is invigorating and motivating.
Can you elaborate on the regulatory roadmap for the U.S., EU and India?
– In both EU and US we have been silent for a while. This autumn we will share the new data with the regulatory agencies. We will share the interim data from our proof of concept study where we have treated resistant and very difficult fungal strains with success, but also important is to show the improvement we have done on the manufacturing side to give reassurance that in totality we have a robust product with potential to treat life threatening fungal infections. For India we are a little bit ahead in the regulatory space as we have done the clinical study which makes the regulatory burden slightly lighter to carry and execute on.
How are you working with clinicians on the ground to ensure patient-centricity and real-world relevance in your clinical programs?
– We are still early in development with our proof of concept study. However, this study has given us a flavor of unmet medical needs. This has inspired us to design our phase 2/3 around more patient-centric measures or real-world evidence. As an example the first patient (47 years old male) failed standard of care, he was then scheduled for surgery which is normal practice in a mucor mycosis infection. The surgery planned was to remove one complete lung meaning his breathing capacity would be reduced by 50%. By giving BSG005 the infection minimized considerably therefore only a smaller part of the lung had to be removed, meaning that he could keep 75-85% of his breathing capacity. To have preserved the ability to breathe better and stronger is vital for a man who is 47 years old. Most likely he has a family to support and by making a less severe impact on his health his chances to support his family is higher. How do we measure this? We have to agree with authorities on endpoints that cover this aspect. The second questions that pops up are: Would it be better if we treated longer and higher doses?
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