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Biosergen AS

Concept Development
Lead Discovery
Lead Optimization
Preclinical Development
Phase I
Phase II
Phase III
Launch

Project: BSG005

The Challenge

Patients most susceptible to systemic fungal infections are those whose immune systems are compromised by diseases such as cancer and those who are receiving immunosuppressive therapy.  Several systemic fungal diseases are potentially life-threatening, and while effective treatments are available, their use is usually limited by serious side-effects or an increasing incidence of drug resistance.

The Solution

Biosergen develops drugs against systemic fungal infections by genetic modification of bacteria that produce antifungal substances.  These new analogues have demonstrated good efficacy against Aspergillus and Candida, which cause the two main invasive fungal infections, as well as against other pathogenic fungi.

Competitive Advantages

Biosergen's novel nystatin analogues have similar properties to amphotericin, a commonly-used treatment for systemic fungal infections, in that they are effective in a broad antifungal spectrum, but are less prone to cause pathogenic fungi to develop resistance to the drug compared with other antimycotics.

The Market

In 2011, the global market for systemic antifungals was estimated to be USD 4.5bn with annual growth of approximately 5 %. Amphotericin and liposomal formulations of amphotericin currently represent about 10 % of the total market1.

Status

  • Based on efficacy studies in vitro and in vivo and toxicity studies in animal models, a candidate drug has been selected (BSG005)
  • Technology transfers for scale-up of manufacturing process and preparations for GMP manufacturing are ongoing

Biosergen_01.jpg

Planned Milestones

  • Complete preclinical documentation of BSG005 as a clinical candidate
  • Start phase I clinical trials

Patent Status

Biosergen's global patent applications cover the modification of the nystatin genetic cluster in Streptomyces bacteria, as well as lead compounds (e.g. BSG005), including semi-synthetically modified compounds.

Commercialization

Biosergen intends to develop the candidate drug to proof-of-concept in a Phase II clinical trial, with a strategic partner that will be able to continue the development further.

 

  1. Source: Datamonitor

 

 

Contact: Nils Spidsøe, CEO | +47 7 359 26 06 | nils.spidsoe@sintef.no | www.biosergen.no