A biomass to treat a difficult and evasive fungal infection with a high mortality rate has been manufactured by Spanish organization, 3P Biopharmaceuticals (3P).
It created BSG005 biomass for its partner and client, Biosergen, a Norwegian biotechnology company that has just announced a phase 2 clinical trial of the product against mucormycosis – also known as the black fungus.
The two companies have been working together for several years building a strong partnership from the early stages of process development and have managed to bring the manufacture of the biomass from small scale to large scale manufacture, close to commercial level.
The biomass is the end product from the fermentation of the bacterial strain developed for the purpose of producing the BSG005 molecule. Having biomass available is a pre-requisite for having a product available for clinical trials such as Biosergen’s mucor trial.
Peder Andersen, Biosergen’s CEO said: “The completion of this manufacture at our partner 3P Biopharmaceuticals in Spain is a major step for Biosergen and our ability to get product available for our clinical phase 2 program which includes the mucormycosis clinical trial, which we are preparing now.
“We have been impressed with the co-operation with 3P Biopharmaceuticals from the early stages of development and we now have large scale manufacture available. The co-operation on management level, on the operational project management level and also on technical level have been excellent. Very professional and excellent communication. We look forward to a continued and expanded co-operation with 3P Biopharmaceuticals.”
The companies state that as a novel fungicidal polyene antifungal product, BSG005 is well positioned to provide a broad single product treatment alternative for life threatening, difficult to treat, resistant, invasive fungal infections.
Different to other polyene products, such as Amphotericin B or Ambisome, BSG005 is without any signs of nephrotoxicity. Mucormycosis falls into this category, as this fungus disease has a high mortality rate and only the polyene Amphotericin B has shown strong efficacy against this fungus. Therefore, as a novel polyene without nephrotoxicity BSG005 could become the drug of choice for the treatment of Mucormycosis.
Mucor fungal strains often establishes itself in the patient’s nose or sinusis and even in the eyes which over a matter of days have to be surgically removed to avoid the infection spreading to the brain, which leads to the high mortality or life-long disabilities. Mucormycosis can also be established on other organ systems in the body such as the lungs or intestines.