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Regulatory press release

Biosergen AB: Biosergen Doses First Patients in Second Cohort of BSG005 Clinical Trial for Life-Threatening Fungal Infections

2024-11-26 11:57
Biosergen
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November 26, 2024 - Biosergen AB ("Biosergen"), a clinical-stage biotechnology company developing therapies for life-threatening fungal infections, is pleased to announce that the first two patients in the second cohort of its ongoing proof-of-concept clinical trial for BSG005 has successfully begun treatment with BSG005. The patients are suffering from a severe infection caused by Aspergillus and Mucor Mycosis respectively. These two patients represent challenging cases where current antifungal treatments have proven ineffective due to resistance and renal impairment.

"It is exciting to advance to this next stage of dosing with BSG005," said Tine Olesen, CEO of Biosergen. "For patients with no effective options, BSG005 has the potential to be lifesaving, especially if the promising safety and efficacy results from the first cohort continue. As we progress through dose escalation, we hope to continue to observe no severe side effects, allowing us to gain deeper insights into BSG005's potential for patients in critical need."

Following positive safety and efficacy results from the first cohort, the trial's independent Data Safety Review Committee approved progression to higher dosing in this second cohort. This phase initiates patient treatment at 0.8 mg/kg per day, with potential escalation up to 1.5 mg/kg depending on patient response and safety.

The second cohort will include up to five patients and is performed in collaboration with Biosergen's partners in India, as with the first cohort. Biosergen aims to develop BSG005 as a new standard for treating invasive fungal infections in patients who are resistant to existing treatments or are ineligible for such treatment due to kidney impairment.

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