First Patient in Biosergen Clinical Trial Treating with BSG005 for Life Threatening Fungal Infection
Stockholm, Sweden – July 12, 2024 – Biosergen AB (“Biosergen”) is pleased to announce that the first patient suffering from an invasive fungal infection has been dosed with BSG005 as rescue therapy.
‘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.
For more information
Tine Kold Olesen, CEO
Telephone: +45 3135 5707
E-mail: tine.olesen@biosergen.net
Niels Lauren, CFO
Telephone: +45 4014 5059
E-mail: niels.laursen@biosergen.net
Certified Adviser
Carnegie Investment Bank AB (publ)
About Biosergen, www.biosergen.net
Biosergen is a clinical stage biotechnology company dedicated to discovering and developing novel antifungal therapies for life threatening fungal diseases. Biosergen’s mission is to develop drug candidates into a new first line treatment choice for resistant and/or difficult to treat invasive fungal infections, in order to save thousands of lives of immune-compromised cancer- transplant- and AIDS patients every year. Biosergen’s shares are listed on the Nasdaq First North Growth Market (OMX: BIOSGN).
About Alkem Laboratories, www.alkemlabs.com
Alkem Laboratories Ltd is an Indian pharmaceutical company engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals in acute and chronic therapeutic areas, such as anti-infective, pain and analgesics, vitamins/minerals/nutrients, cardiac and Diabetology, Gynecology, neuro/central nervous system, dermatology, anti-diabetes, anti-osteoporosis, cardiovascular, and muscle relaxants, which are marketed in Indian and International markets. It operates through the pharmaceutical business segment.