Utprøving av nyttlegemiddel mot sytemiske soppinfeksjoer

Offentlig prosjektsammendrag

Biosergen AS is developing the novel drug BSG005 for the treatment of severe systemic fungal infections. The main goal of the development program is to characterize the product profile with respect to safety and efficacy in Human. This will be done through pre-clinical and toxicology studies, improvement of the production process, optimization of the formulation and execution of clinical Phase I/II studies. The project team, the involved partners (SINTEF and RISE) and the health care specialists engaged in the leadership of Biosergen, together constitute a team well capable of implementing the necessary R&D activities to ensure a successful delivery of the project. In the past 20-30 years, fungi have become a major health threat, primarily du to an increasing numbers of patients who have compromised immune systems, such as people who are receiving chemotherapy, have received solid organ transplants, or are undergoing surgery. Fungal infections are the seventh leading cause of infection-related mortality with up to 90% mortality with certain fungal strains. New safe and efficient drugs are needed. BSG005 is a polyene fungicidal drug with superior safety and efficacy characteristics compared to available products on the market. Substantial preclinical data demonstrate a broad spectrum of antifungal activity (fungicidal) combined with a low toxicity. The product is effective against multi-resistant fungi strains and is not expected to lead to resistance development. The current treatments have limitations in efficacy and safety. Hence the project has a high value for society as well as offering a substantial commercial opportunity for Biosergen.