Biosergen has reported promising results from the second cohort of patients in its proof-of-concept clinical trial for BSG005, a novel antifungal agent designed to combat life-threatening fungal infections, including multidrug-resistant strains.
The trial, conducted in India, has shown significant clinical benefits across eight patients who completed treatment in the second cohort. Two patients achieved complete recovery, while six others demonstrated substantial improvement. Notably, no severe side effects were reported, even among patients with kidney impairment or known intolerance to Amphotericin B, a current standard treatment.
"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," said Tine Olesen, CEO of Biosergen.
Rising Threat of Resistant Fungal Infections
The development comes at a critical time as fungal infections, particularly multidrug-resistant strains, have been identified by the World Health Organization as top-priority threats. Current antifungal medications, many developed decades ago, are increasingly ineffective as fungi evolve resistance mechanisms.
BSG005 represents a potential breakthrough in addressing this growing public health concern. Unlike azoles and echinocandins, which are fungistatic (inhibiting fungal growth), BSG005 is fungicidal, actively killing fungal cells including resistant strains such as Candida auris, as demonstrated in preclinical studies.
Clinical Impact and Patient Benefits
The real-world impact of BSG005 was illustrated by Olesen through the case of a 47-year-old male patient who had failed standard care for a mucormycosis infection. Initially scheduled for complete lung removal, treatment with BSG005 significantly reduced the infection, allowing surgeons to remove only a small portion of the lung.
"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," Olesen explained. "To have preserved the ability to breathe better and stronger is vital for a man who is 47 years old."
Manufacturing and Regulatory Progress
Biosergen is now preparing for the third patient cohort, scheduled for Q4 2025. The slight delay is attributed to higher dosing requirements. In partnership with Alkem Laboratories, the company is manufacturing a new GMP-compliant batch of BSG005 to support this cohort and future global trials, ensuring compliance with regulatory agencies including the FDA and EMA.
On the regulatory front, Biosergen is advancing discussions with India's Central Drugs Standard Control Organisation (CDSCO) to plan a Phase II trial. The company is also preparing for a pre-IND meeting with the U.S. FDA, a critical step toward initiating clinical trials in the United States.
In collaboration with Alkem, Biosergen is designing a global Phase II/III adaptive trial for aspergillosis, targeting approximately 150 patients.
Strategic Leadership Expansion
To strengthen its leadership team, Biosergen has proposed the election of Dr. Marco Taglietti to its Board of Directors. Dr. Taglietti brings valuable experience having led successful clinical programs and secured major regulatory approvals in the past. His expertise in licensing and partnerships is expected to support Biosergen's international expansion ambitions.
Financial Position
Financially, Biosergen appears stable with a cash position of SEK 44.8 million at the end of Q1 2025. The company reported an operating loss of SEK 5.1 million for the quarter, an improvement from SEK 6.9 million in Q1 2024, reflecting continued investment in research and development.
Future Outlook
Looking ahead, 2025 could be transformative for Biosergen as its clinical, regulatory, and manufacturing efforts converge. The company plans to share new data with regulatory agencies in both the EU and US this autumn.
"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," said Olesen.
For India, Biosergen is further along in the regulatory process, having already conducted clinical studies there, which somewhat reduces the regulatory burden for future development.
As multidrug-resistant fungal infections continue to pose a significant global health threat, Biosergen's BSG005 represents a potential new weapon in the medical arsenal against these deadly pathogens.
