"Every opportunity to gain time or market share is being thoroughly explored", says Tine.
Biosergen develops BSG005 with the goal of providing a treatment for patients with invasive fungal infections, which can be life-threatening. The company is conducting a clinical study to evaluate BSG005 as a salvage treatment for patients where other treatment options have failed. This open-label, dose-escalation phase Ib study is evaluating the safety, tolerability and efficacy of BSG005 in 15 patients in intensive care units in India.
Further evidence of BSG005's efficacy
The first cohort, which was completed in late 2024, showed promising results with four out of five patients either recovering completely or showing significant clinical improvement. 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 a severely compromised condition at the start of the study. One critically ill patient with mucormycosis made a full recovery, further confirming the drug's life-saving potential. Two patients with aspergillus, who had failed standard treatments, showed clear clinical improvements, and one patient with a co-infection of both mucormycosis and aspergillus also achieved significant benefits. One patient chose to withdraw from the study due to discomfort. These results underscore BSG005's broad-spectrum efficacy and its potential to fill an urgent medical need where existing treatments are inadequate.
The second cohort further confirms BSG005's potential and the results are in line with the first cohort, where all patients who completed treatment experienced positive effects.
Future plans
During the initial phase of the study, researchers observed that BSG005 was safe, and in the absence of serious safety signals, it was assessed that some patients could benefit from longer treatment times and higher doses than initially planned. Biosergen therefore approved an extension of the study, which led to higher drug utilization than expected. Consequently, the company now needs to replenish the drug inventory before the third cohort can be initiated in the fourth quarter of 2025.
With these promising results, Biosergen is now focusing on strategic initiatives to ensure the continued development of BSG005. The company plans to compile a clinical report and initiate regulatory discussions in both India and the US. Biosergen is in dialogue with Central Drugs Standard Control Organization (CDSCO) in India to identify the most effective path towards a Phase II study. At the same time, an Investigational New Drug (IND) application is being prepared with the US Food and Drug Administration FDA – an important step towards clinical studies in the US.
CEO's comments
BioStock contacted Tine Olesen for a comment on the latest results from the phase Ib study.
You, 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.