Biosergen recently announced the completion of treatment for the first cohort of patients in its proof-of-concept trial for its antifungal drug candidate BSG005. Most patients improved significantly, reflecting BSG005’s potential as a life-saving therapy. The next step involves dose escalation for the upcoming cohort. Importantly, between November 18 and 29, shareholders can exercise the warrants TO3, which could add a maximum of approximately SEK 45 million to the company, funding it well through 2025.

Biosergen is advancing BSG005 as a potential treatment for patients facing life-threatening invasive fungal infections. In partnership with Alkem Laboratories Limited, the company runs a proof-of-concept study to assess the drug candidate as a rescue therapy specifically for patients who have not responded to standard treatments and/or have shown intolerance to treatment and/or have impaired kidney function. This study, which includes dose escalation, is focused on determining the safety, tolerability, and effectiveness of BSG005 in a group of 15 critically ill patients in intensive care units across India.

Continued success with BSG005

Biosergen earlier this fall marked a crucial achievement with the candidate’s successful impact on a patient battling invasive Mucormycosis, a severe fungal infection often necessitating major surgical intervention in the affected tissues or organs. For this patient, BSG005 eliminated that extreme necessity. After a 28-day escalating dose treatment, not only did the infection alleviate, but the patient avoided lung removal, and recovered from his infection and his kidney function stabilised without the need for surgery.

Following this success, Biosergen last week completed treatment for the first full cohort of five patients in the study. The group included individuals facing similar treatment challenges: In total, two patients with invasive Mucormycosis and three with invasive Aspergillus infections. Three of these five patients had shown resistance to multiple standard antifungal drugs, and one suffered from kidney impairment that restricted treatment options. Among the treated patients, two fully recovered, two showed significant improvement, and only one severely ill patient, whose condition was already critical, passed away due to causes unrelated to BSG005.

Severely sick patients recovering

The results offer promising evidence of BSG005’s effectiveness in some of the most challenging fungal infections. For example, Aspergillus infections in immunocompromised patients can have mortality rates of up to 80 per cent when resistant to available treatments. Despite the bleak outlook for such cases, BSG005 enabled three patients with drug-resistant Aspergillus infections to recover enough to leave the hospital and resume their lives. Notably, BSG005 was effective at low doses, and no patients experienced severe side effects — a hopeful indication that higher doses could lead to even better outcomes.

Next steps with BSG005

With the first cohort’s completion, an independent data safety review committee is set to evaluate the findings. Pending approval, Biosergen plans to escalate the dosage in the second cohort, potentially furthering BSG005’s effectiveness. The company aims to treat up to 15 patients in three cohorts and complete the proof-of-concept trial by January 2025.

Financial stability through warrant TO3

Biosergen is leveraging its TO3 warrants to sustain its clinical advancements, allowing shareholders to further support the company’s progress. If fully subscribed, TO3 could yield up to SEK 45 million during the exercise period from November 18 to November 29, 2024. This funding would secure Biosergen’s operational runway well through 2025.

CEO’s comments

BioStock contacted CEO Tine Olesen to learn more about the latest achievements and what’s coming next.

Tine, could you elaborate on the implications of the improvements and recoveries observed in these patients in the first cohort?

— We have achieved very promising results in the first cohort. First of all, we have shown that BSG005 is safe, which is a critical milestone in its development. Moreover, the results are showing indications of strong efficacy. While discussions about invasive fungal infections often focus on mortality rates, we also need to consider quality of life. For patients, survival is paramount, but minimizing the need for invasive interventions, like lung removal, is also a significant advancement. For example, in one of our cases, we managed to avoid such a procedure, marking a major step forward in both survival and quality of life outcomes for patients with invasive fungal infections.

Given that the initial cohort showed promising results even at low doses, how do you anticipate BSG005 will perform as you increase doses in future cohorts?

— Currently, the standard of care for these critically ill patients often involves initial medical treatment followed by surgery. With higher doses of BSG005, I’m optimistic that we may cure patients without the need for invasive procedures. Avoiding surgery is a significant benefit — not only for patients, who face fewer risks and complications, but also for hospitals and healthcare systems overall. This advancement could address a substantial unmet medical need, offering a more comprehensive solution for patients with life-threatening infections.

How does BSG005 differ from other antifungal treatments in terms of its mechanism, and why is it effective against drug-resistant strains?

—BSG005 belongs to a highly effective class of antifungal drugs that actively kill the fungus, preventing it from mutating and developing resistance. In fact, some drugs in this class have been used for over 70 years with minimal resistance observed. In contrast, many widely used antifungals only inhibit fungal growth, which gives the fungus a chance to mutate and become resistant over time. Preventing resistance is critical, not just for the health of individual patients but also for safeguarding broader public health.

Could you elaborate on the specific challenges in developing a treatment for invasive fungal infections?

—Invasive fungal infections have long been an underserved area, with limited research spanning from the fundamentals of fungal disease and epidemiology to diagnostics and treatments. All of these are essential to advance new therapies. However, this is beginning to change as evidence of a wider geographic spread of invasive fungal diseases has prompted increased attention and funding from both government and private organizations.

In the past three years, we’ve seen the development of better, faster, and more affordable diagnostic tools, allowing for earlier intervention and significantly improving outcomes by reducing disease severity and transmission. The next critical step is developing more effective treatments, especially those that do not contribute to drug-resistant fungal strains. BSG005 represents a promising solution in this regard.

How will the funds from the upcoming exercise of the TO3 warrants be utilised?

—The funds will primarily support our preparation of phase 2 and 3 studies and advance our clinical development in collaboration with our partner, Alkem Laboratories. A key priority is securing the additional medication required, with the next step focused on manufacturing BSG005 at scale. We’ll also be preparing for regulatory interactions with major agencies to ensure our development aligns with their standards and expectations. Finally, we will continue to seek partners to plan for future investments as we have done successfully with Alkem Laboratories.

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