Biosergen’s CEO: “These findings open up new possibilities”
Biosergen’s antifungal drug candidate, BSG005, continues to show strong clinical potential. The majority of the patients in the second cohort either fully recovered or significantly improved, consistent with earlier results. With these encouraging outcomes, Biosergen is advancing key regulatory and development plans for BSG005. BioStock reached out to CEO Tine Olesen to get her comments on this achievement.
“Every opportunity to gain time or market share is being thoroughly explored”, says Tine.
Biosergen is developing BSG005 with the goal of offering a treatment for patients with invasive fungal infections, which pose a life-threatening risk. Biosergen is conducting a clinical study with the primary aim of evaluating the potential of BSG005 as a rescue treatment for patients that have failed other treatment options. This open-label phase Ib study with dose escalation will evaluate the safety, tolerability, and efficacy of BSG005 in 15 patients in intensive care units in India.
Further evidence of BSG005’s effectiveness
The first cohort, completed in late 2024, delivered promising results where four out of five patients either fully recovered or showed significant clinical improvements. All patients had difficult-to-treat Mucormycosis or Aspergillus infections. Read more here.
On February 4, Biosergen announced data from the second cohort, which included five patients with life-threatening fungal infections, several of whom were in deteriorated conditions at the start of the study. Notably, a critically ill Mucormycosis patient fully recovered, reinforcing the drug’s life-saving capabilities. Two Aspergillus patients, previously unresponsive to standard treatments, showed marked clinical improvements, while a patient with a co-infection of both Mucormycosis and Aspergillus also benefited significantly. One patient voluntarily withdrew from the trial due to discomfort. These outcomes highlight BSG005’s broad-spectrum antifungal efficacy and its potential to address urgent medical needs where existing treatments fail.
The second cohort further confirms BSG005’s potential and are consistent with those from the first cohort, where all patients who completed treatment experienced positive outcomes.
Plans going forward
During the early days of the study, investigators observed that BSG005 was safe and due to the lack of severe safety signals, some patients would benefit from longer treatment durations and higher doses than initially planned to maximise recovery and reduce the risk of relapse. In response to these findings, Biosergen approved an extension of the trial, which resulted in a higher-than-expected usage of BSG005. Consequently, the company now needs to replenish its drug supply before initiating the third cohort in Q4 2025.
With these promising results, Biosergen is now focusing on key strategic initiatives to ensure the continued advancement of BSG005. Biosergen plans to compile a clinical report and initiate regulatory discussions in both India and the U.S. The company is engaging with the Central Drugs Standard Control Organisation (CDSCO) in India to determine the most efficient pathway for initiating a phase II clinical trial. Additionally, the company is preparing for an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), a crucial step toward conducting clinical trials in the US.
CEO comments
BioStock reached out to CEO Tine Olesen to have her comment on the latest data from the phase Ib study.
Tine, how do the results from the second cohort compare to your initial expectations for BSG005?
– It is truly rewarding to witness the positive results we are achieving. Our closest competitor faces restrictions in dosage and treatment duration due to severe side effects. Without those limitations, we have the potential to deliver profound outcomes for patients, offering them a longer lifespan and an improved quality of life
What do these findings mean for the overall development timeline of BSG005?
– These findings open up new possibilities, and every opportunity to gain time or market share is being thoroughly explored. We may secure additional orphan designation indications beyond the one we currently hold, which provides access to an expedited regulatory process. However, more data — including comparative studies — is essential to fully demonstrate the true benefits.
You are planning to conduct clinical trials in the US. Are you considering expanding the clinical trials to additional countries?
– We plan to operate globally. Obtaining an IND will open doors to most international markets, as FDA approval often serves as a strong indicator of worldwide acceptance.
When do you expect to share the next update from the study?
– We have scheduled a safety review board meeting for mid to late March, where independent experts will conduct a thorough analysis of the data we’ve collected. Based on their evaluation, they will recommend whether to complete the study, continue as is, or increase the dosage. Their insights will be highly valuable and eagerly anticipated.
