What does Biosergen do?
Biosergen is a biotech company developing a new anti-fungal product for use in life-threatening invasive fungal infections. It is based on research done at the Technical University in Trondheim and the private research organization Sintef in Trondheim. All the original research was applying new technology on modifying certain gene clusters in a bacterial strain that produces this special polyene macrolide molecule. After a large pilot manufacture and testing exercise BSG005 was chosen to be the molecule to advance. After an extensive pre-clinical and toxicological testing program and preparation for manufacture and formulation of BSG005, Biosergen is now starting human clinical trials in phase I.
What makes BSG005 so interesting?
BSG005 belongs to the polyene macrolide class of drugs. The main marketed product in this class (Amphotericin B) has been on the market for 50 years, it is fungical (it kills fungus) and there has been no fungal resistance build up against this product over all the years. BUT it has in particular a toxic effect on the kidneys and has mostly been used as a last resort, when all other products failed even if formulation advances have been made with special lipid formulations.
When BSG005 was tested in vitro on a large number of fungus strains, it showed a broad fungicidal effect towards almost all fungus strains – especially also towards resistant fungus strains including resistant Aspergillus strains.
And most importantly in the large 28-day long toxicology test in both rat and dog there was no adverse effects on the kidneys – not even on histological tissue examination. It was a clean test.
That is a very important advantage and will be a major differentiation for the treatment of these life-threatening infections. Remember the mortality is between 20 and up to 95% depending on the fungus type/strain and country.
You have several versions of BSG005 in the pipeline, what are the differences?
BSG005 is a polyene macrolide drug, and the efficacy of this drug class is un-disputed. The standard formulation is distributed evenly all over the body and to all organs. We are looking for special formulations that will provide advances compared to the standard BSG005. We are applying special technologies to achieve a formulation that will deposit a major part of the infused product in the lungs, which is the typical starting focus of these serious infections, with the aim to hit the fungus hard and kill it fast.
Using same technology, we are developing an oral formulation which could have potential use as prophylactic treatment for patients at risk to develop such invasive fungal infection in relation to e.g. hematological or solid organ transplantations and severe chemotherapy for cancer. It could also be a follow up treatment after an initial intravenous treatment in hospital to get the infection under control and then letting the patient come home and be followed in the outpatient care with standard testing to follow the progress under oral BSG005 treatment.
Both developments can add important advantages to the use of BSG005 compared to other products.
How would you describe the market?
The global anti-fungal market is a total 16 B USD dominated by a number of Azole class compounds and Echinocandin class compounds. These compounds take a major share of the market, are cheap (relative) but resistance is building up against several of the products especially the Azoles. The polyenes take 10% of the market. Amphotericin B is the primary polyene and has annual sales for invasive fungal infection of 500 M USD.
Currently the Azoles and some Echinocandins are drugs of first choice. They are however mainly inhibiting further growth of the fungus and Amphotericin B has better efficacy but has kidney toxicity and hence is mainly a last resort if other products have failed.
Biosergen has in its strategy to apply for first drug choice status for BSG005, if the safety data from phase I and phase II supports that there is no kidney toxicity, as we have seen in the toxicology. If that can be achieved, it opens for much broader use of BSG005 for invasive fungal infections.
Biosergen has been successful in attracting public funding. How much public funding have you gotten so far and are you still getting that type of funding?
Biosergen has so far obtained public funding in total of 28 M NOK from the Norwegian Research Council. We have the Nano project ongoing right now and have submitted a further application for an extra project, which if granted will let us start this project in August this year.
Biosergen is also starting to look at the EU funding which is open for applications now. Biosergen will continue to apply for such public grants. It is a great help to achieve our goals and get BSG005 fully developed for the market, where there is a high medical need for this product.
You are doing an IPO on Nasdaq First North, what will the capital be used for?
The timing is right for an IPO. Biosergen is entering the clinical development stage and that requires larger funding, that our current investors cannot handle. We are going with the IPO to secure funding for the development program. The proceeds from the IPO will be used for:
– Running and completing our safety and tolerability phase I clinical trial in healthy volunteers in Australia.
– Manufacturing BSG005 in a scale large enough to supply our phase II program and further development of the product.
– Submit the clinical trial application for our first phase II trial.
– Advance our Nano-project as far as possible.
Lastly, what would you like to say to investors that are interested in Biosergen?
Biosergen develops BSG005 as a unique drug that will cover a high medical need in invasive fungal infections. Biosergen is now entering the clinical development phases. BSG005 is a polyene fungicidal product, where the efficacy is un-disputed, and the key is on safety and tolerability on the kidneys. If the phase I trial comes out showing excellent kidney safety, then a major value infliction point has been reached and BSG005 will become a product to discuss in this field and it will stimulate the interest from big pharma in BSG005 and Biosergen.