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Biosergen on dosing the first patient with life-threatening fungal disease

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Biosergen on dosing the first patient with life-threatening fungal disease

18 July, 2024

The first patient has been dosed in Biosergen’s clinical phase Ib trial with BSG005, intended as rescue therapy for invasive fungal infection to increase survival rates for these critically ill patients. Topline results are anticipated by year-end or early 2025.  BioStock reached out to CEO Tine Kold Olesen to learn more about the latest achievement.

Swedish biotech company Biosergen is targeting a major global health threat: invasive life-threatening fungal infections. Every year, more than 6.55 million people worldwide contract a severe fungal infection, leading to over 3.75 million deaths. Of these, around 2.55 million fatalities are directly caused by the fungal diseases.

Milestone achieved with BSG005 as rescue treatment

In partnership with one of the top five largest pharmaceutical companies in India, Alkem Laboratories Limited, Biosergen has launched the first clinical trial for patients with severe fungal infections. This study aims to assess the company’s leading drug candidate BSG005‘s potential as a rescue treatment, based on its promising safety and efficacy shown in preclinical studies and phase I trials, which reported no severe adverse effects.

Last week, Biosergen announced a major milestone with the administration of the first dose of BSG005 to a patient in this study. The aim of the study is to improve survival rates for critically ill patients battling hard-to-treat fungal infections and/or those resistant to existing antifungal treatments. There is a pressing medical need for effective treatments for the millions affected by life-threatening fungal diseases annually, especially those with compromised immune systems.

This phase Ib open-label, dose-escalating study will evaluate the safety, tolerability, and efficacy of BSG005 in 15 patients in an ICU setting in India. Results are expected by year-end/Q1 2025. The study targets patients who cannot tolerate or are resistant to Amphotericin B, the current last-resort treatment for severe invasive fungal diseases, including those who failed first-line therapy due to antifungal resistance and those with mild to moderate kidney impairment. These patient groups urgently need new treatment options as there are no effective alternatives available.

CEO comments

BioStock reached out to CEO Tine Kold Olesen to learn more about the phase Ib study.

Tine Kold Olesen, CEO Biosergen
Tine Kold Olesen, vd Biosergen

Tine, how are you going to measure the success of BSG005 as a rescue treatment in this patient population?

– There are three main success factors in the study. Number one is that BSG005 is safe and tolerable, number two is that it is effective, number three we get an idea of dose range in different fungal strains to plan for our next clinical studies.

What specific survival rates are you aiming to achieve with BSG005 in this clinical study?
– In general mortality/survival rates are dependent on the fungal strain and the disease burden, this is how benchmarks are described in epidemiology studies. We have a basket study where the fungal strain is not the determining factor for inclusion but the fact that patients have resistant and/or difficult to treat life-threatening fungal disease. These patients have lack of efficacy or have safety issues with current marketed therapy. It is an open label study including patients that have limited or no other treatment options. Therefore, any patient we can stabilise or cure within a period of 28 days is a success. It is a fast way to do a proof-of-concept study, where we will confirm what we have seen on the performance of BSG005 pre-clinically in terms high potency, broad spectered and safe.

What are the potential risks associated with administering BSG005 to critically ill patients?
– This is a new drug, we have done our homework with pre-clinical studies and a phase 1 study in healthy subjects with good outcomes, but there is always an inherent risk the first time you test in patients. One of the key risks is that we do not know the dose and the tolerability profile in patients. To mitigate that risk, it is allowed to titrate the dose up or down based on the efficacy/tolerability profile. Another mitigating factor is that we have an independent panel of fungal experts to evaluate the response on an ongoing basis and adjust the treatment as we progress.

What are the next steps if the phase Ib study results are positive?
– The next step is together with our partner Alkem to plan for the coming clinical studies.  A study in aspergillosis patients has high priority. Biosergen has orphan drug status granted by the FDA and there is a very high incidence in India. The global mortality rate in aspergillosis patients is 75% and thereby there is a high unmet medical need and an urge for more effective treatments.

Finally, does Biosergen have plans to conduct similar studies in other regions or with different patient demographics?
– We will approach regulatory authorities after we have finalised the study and analysed the data. If we have positive data it might open up for a compassionate use/expanded access program globally, where we can continue to collect data in critically ill patients that have no other treatment options and thereby bolster our database with additional important clinical data. This type of programs are beneficial for patients that have limited treatment options and it bridges the experimental data and full approval.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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