Biosergen

`Today marks a significant milestone as the first patient has received the first dose of our lead candidate BSG005. The goal with the study is to increase survival rates for these very ill patients with difficult to treat fungal strains or/and with resistance to current antifungal treatment. There is a significant unmet medical need for the many millions of people infected with and dying from life-threatening fungal diseases each year, particularly immunocompromised individuals. ' CEO Tine Olesen states.

In collaboration with Alkem Laboratories Limited ("Alkem"), India, we have successfully initiated the first clinical study involving patients with life threatening fungal infections. The primary objective of this patient study is to evaluate the potential of BSG005 as a rescue treatment, building on its promising safety and efficacy profile demonstrated in preclinical studies and Phase 1 trial results, which reported no severe side effects.

The study is a phase 1B open label, dose escalating study designed to investigate the safety, tolerability and efficacy in 15 patients in an acute care setting (ICU) in India. Topline results are expected in Q1 2025/ by year-end. In this clinical study BSG005 is given as rescue therapy to patient populations intolerant or resistant to Amphotericin B, the current last-resort treatment for severe invasive fungal diseases. This includes patients who have experienced treatment failure with first-line therapy due to anti-fungal resistance formation, as well as those with mild to moderate kidney impairment are enrolled. These populations urgently need alternative treatment options, as no effective alternatives are currently available.

The study will be conducted with the company's partner Alkem in India. Alkem will continue the development in India both financing and conducting phase 2 and 3 studies in India.  Alkem is among the five largest pharmaceutical companies in India, is a leader in the anti-infective market and has more than 17,000 employees, with affiliates in the USA, Australia, UK, Germany and many other emerging countries.

Globally, it is estimated that over 6.55 million people are affected by an immediately life-threatening fungal disease each year, resulting in over 3.75 million deaths, of which about 2.55 million are directly attributable to fungal diseases.