Biosergen

October 31, 2024 - Biosergen AB ("Biosergen"), a clinical-stage biotechnology company developing therapies for life-threatening fungal diseases, today announced the completion of treatment for the first cohort of patients in its proof-of-concept clinical trial for its antifungal drug-candidate BSG005. The cohort consisted of five patients: two completely recovered, two saw significant improvements, and one very sick patient passed away because of unrelated causes to BSG005. The trial is evaluating the company's drug candidate, BSG005, as a rescue therapy for patients who have either failed previous standard-of-care antifungal treatments due to lack of efficacy or safety, or patients with mild to moderate kidney impairment.

In this first cohort, three of the enrolled patients had shown resistance to standard-of-care antifungal treatments, while one patient was ineligible for standard-of-care due to kidney impairment and one patient had both resistance to standard of care antifungal treatments and kidney impairment. Three of the five patients were treated for invasive Aspergillus infections, while two were treated for Mucormycosis infections (one of whom passed away). No severe side effects were observed in any of the patients.

"To see improvements in multiple patients resistant to other treatments at relatively low doses of BSG005 is a notable success. However, seeing two patients who had suffered from some of the most severe fungal infections existing in the world today fully recover is truly remarkable," said Tine Olesen, CEO of Biosergen. "These invasive fungal infections, whether resistant or susceptible to standard treatments, are associated with high mortality rates. For example, invasive Aspergillus infections that are susceptible to standard-of-care treatments have mortality rates of around 30-50% in patients with weakened immune systems. However, drug-resistant Aspergillus infections can result in mortality rates between 50-80%, depending on the patient's underlying health conditions. The fact that BSG005 is showing such positive impacts at this early stage of the trial is very encouraging. We look forward to observing more results as we expect to increase the dose in the coming cohorts, pending confirmation by the data safety review committee."

The three patients suffering from Aspergillus infections had previously undergone extensive treatment with various antifungal drugs, including azoles such as itraconazole voriconazole, and posaconazole, with limited or no success. Despite these prolonged treatments, their conditions had worsened, leading the clinical investigator team to classify them as having breakthrough invasive fungal infections-a strong indicator of being infected with drug-resistant strains. All three were able to leave the hospital and carry on with their lives following the treatment with BSG005, with the investigator team offering follow-up monitoring. The same was true for the successfully treated Mucormycosis patient, as detailed in a press release on August 30, 2024. It is also worth noting that in none of the cases the blood parameters of interest showed any indication of being impacted by the BSG005 dosing. These include creatinine levels (indicative of kidney damage), potassium levels (impacting heart rhythm), and magnesium levels (potentially causing general malaise), which are often elevated when such serious infections are treated with Amphotericin B, currently the last-resort treatment for these infections.

Resistance to standard-of-care treatments can be attributed to several factors. One major driver is the widespread use of azole antifungals in agriculture, where they are applied as fungicides in crop production. This practice indirectly promotes resistant strains through natural selection, allowing them to spread in the environment once non-resistant strains are eliminated. Additionally, the long-term use of antifungal therapies in hospital settings, often for preventive purposes, also contributes to the development of resistance.

The emerging threat of drug-resistant fungal infections, observed in all patients within this first cohort, was recently recognized at the highest levels on the international stage. In September 2024, global leaders at the United Nations General Assembly adopted a political declaration requiring all countries to develop, update, and implement national action plans on antimicrobial resistance (AMR) by 2030, with antifungal resistance playing a key role in AMR. The declaration underscores the need for coordinated, multisectoral action backed by sustainable human and financial resources. This international commitment aligns closely with Biosergen's mission, and we are committed to positioning BSG005 as part of the solution to the broader, global AMR challenge.

Pending confirmation by an independent data safety review committee, who will review the data from cohort 1, the ongoing proof-of-concept trial is planned to proceed with the enrollment of a new cohort. This next cohort might include five additional patients also suffering from various invasive fungal infections, but with higher doses of BSG005 administered throughout the dose-escalating treatment cycle. In total, Biosergen aims to treat up to 15 patients across three cohorts by January 2025. However, it depends on how high doses patiwnts will receive in cohort 2. The goal of the proof-of-concept trial is to assess the safety, tolerability, and efficacy of BSG005.

Biosergen's partner, Alkem Laboratories, a leading Indian pharmaceutical company with extensive clinical development expertise, will finance and conduct subsequent Phase 2 and 3 trials in India, contingent on the successful completion of the current trial. Biosergen retains all commercial rights for BSG005 outside of India.