Revolutionizing Antifungal Treatment
Introducing BSG005, a groundbreaking antifungal drug developed by Biosergen. With superior safety and potency, BSG005 aims to combat invasive fungal infections that pose a serious threat to immunocompromised patients, including those with AIDS, cancer, and transplant recipients.
What is Invasive
Fungal Diseases?
Invasive fungal diseases (IFDs) are a serious and often life-threatening group of infections caused by fungi that invade tissues and organs. These infections can be serious and even fatal, especially in people who are immunocompromised.
Fungal infections are increasingly becoming a global health problem that is associated with high morbidity and mortality rates as well as devastating socioeconomic consequences. 90% of systemic fungal infection-related deaths are caused by five species:
The extensive use over the last decades of safer but fungistatic rather than fungicidal agents, particularly of the azole class, has led to the emergence of multidrug resistant (MDR) fungal pathogens. This situation is now recognized by the WHO and Centre of Disease Control (CDC) in US and Europe as a global health threat
Candida species are most common in hospital-acquired infections
life-threatening
infections per year
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(% in infected populations)
Mortality rates
Aspergillus species are predominant in immunocompromised patients, i.e. cancer and HIV patients
life-threatening
infections per year
Infections per year
(% in infected populations)
Mortality rates
Cryptococcus and Pneumocystis also contribute to the significant morbidity and mortality associated with invasive fungal infections
life-threatening
infections per year
Infections per year
(% in infected populations)
Mortality rates
Pneumocystis also contribute to the significant morbidity and mortality associated with invasive fungal infections
life-threatening
infections per year
Infections per year
(% in infected populations)
Mortality rates
Mucormycosis has a low incidence of life-threatening infections compared to the other species, but is associated with high mortality rates
life-threatening
infections per year
Infections per year
(% in infected populations)
Mortality rates
BSG005: A New Era in Antifungal Treatment
BSG005 offers comprehensive antifungal coverage across multiple fungal genus, surpassing current treatments. Unlike existing options that are limited by side effects or narrow efficacy, BSG005 is effective against Candida, Aspergillus, Fusarium, Mucor, and Cryptococcus, making it a unique and versatile solution in combating invasive fungal infections. BSG005 is fungicidal i.e. it kills fungal growths and thereby minimises the risk for resistance formation towards treatment, whereas many other treatments are fungistatic i.e. it inhibits growth and thereby there is a risk for mutations and resistance to treament formation.
Superior Safety Profile of BSG005 Antifungal Drug
BSG005, belongs to the class of drugs called polyene macrolides. Polyene macrolides are the most effective antifungals. They can even treat difficult and/or resistant fungal strains, but the current marketed polyene macrolides have severe side effects. One side effect is kidney damage.
NAG is a biomarker for kidney damage. Increasing levels of NAG is an expression for increasing kidney damage. BSG005 has very limited release of NAG and thereby not the severe side effect seen with other polyene macrolides. This has been shown in both animals and healthy subjects
Discover the Effectiveness of BSG005 in Treating Invasive Fungal Infections
Top line results from phase 1 trial in healthy subjects shows no significant side effects!
A classical designed phase 1 study, with 38 healthy males and females receiving a single dose or multiple doses showed:
•No serious adverse event occurred.
•Adverse events were mild to moderate in severity.
•No clinically relevant changes in post baseline laboratory parameters – including kidney, liver and potassium – and no clinically relevant electrocardiogram(ECG) changes.
BSG005 were safe in the healthy subjects.
Our Development
Pipeline
Clinical Trials Progress
Phase 1a: Completed succesfully in healthy subjects. Phase 1b: Ongoing 15 patients planned to receive rescue treatment. Phase 2: An ambitious multi-trial program planned, aimed at broad labelling against invasive fungal infections.
Regulatory Advantage
Orphan Drug Status: Granted by the FDA, providing expedited clinical development and post-approval market exclusivity.
Innovative Formulations in Development
BSG005 Nano Lung: Specifically designed to target lung infections.BSG005 Nano Oral: Enables effective oral delivery
2023
Regulations & First Clinical Trial in Patients with Invasive Fungal Infection
We conduct the first in-patient study with 15 participants to evaluate safety and efficacy. This study continues into 2024 under regulatory and ethics review.
2024
Advancing Clinical Trials & Regulatory Insights
Continuing our clinical trials while preparing comprehensive regulatory evaluation reports to ensure safety and compliance.
2025
Ensuring Quality and Compliance
In 2025, we will focus on Chemistry, Manufacturing, and Controls (CMC) activities and produce Good Manufacturing Practice (GMP) materials for our upcoming Phase 2 studies.
2026
Progressing to Phase 2/3 and Beyond
In 2029, we plan to file for approval of our Aspergillosis treatment in the EU and US. Additionally, we aim to launch treatments for other indications in 2030.
The extensive research behind BSG005
Biosergen’s antifungal drug candidate BSG005 is based on two decades of scientific work at Norweigian University of Science and Tecnology (NTNU) in collaboration with the Department of Biotechnology and Nanomedicine at SINTEF, originally funded by the Research Council of Norway.
Peer reviewed scientific publications from SINTEF, NTNU and the Company describing various aspects of the work to get to BSG005 Located in Trondheim, Norway, SINTEF is one of Europe’s largest private research institutions with more than 2,000 employees.