Thierry Bernardi, PharmaD, is CEO of BioFilm Pharma, a startup developing new antibiotics that specifically target the bacterial biofilm. Their candidates are news entities and 3Biotech is here to make sure they smoothly reach Phase I. In this interview, he explains what are the key challenges an early stage development  startup can face and how 3Biotech helped in the drug development strategy.

Thierry can you introduce us BioFilm Pharma?

BioFilm Pharma was founded in June 2017. It’s BioFilm Control’s sister company, a diagnostic and microbial R&D services company founded in 2005. We do antimicrobials research, with a special focus on their antibiofilms effects (which is a way where bacteria can become resistant).

We have decided to create a new structure dedicated to Drug Discovery because those 2 activities are totally different and then, had to be managed in different ways.

At what step are you now?

We’ve recently completed 2 years of screening and we will now qualify our molecules ex-vivo, this is the “hit-to-lead” step. The results are promising, we have identified 10 “first in class” pure antibiofilms (which means they have no activity on planktonic bacteria) and 20 superantibiotics that are also antibiofilms.

The molecules we have screened come from the banks of already qualified ones. It was our wish  not to explore the biodiversity with a risk to match with “undruggable” compounds, because of the difficulties to extract or synthesize them. We focused on banks that are free of patents, qualified and druggable.

What About the Indications?

We are working on a rich panel of molecules with an anti-Staphylococcus narrow spectrum and others with a broader one against ESKAPE in general. In all cases, we target chronic infections associated with the biofilm.

In terms of incidence, the first one concerns wound infections, with the diabetic foot ulcer (DFU) topping all of them. The last epidemiologic information I had stated that there are around 50 million cases a year in the world, resulting in 80,000 limb amputations in USA only. This is dramatic for a lot of patients; their infection can last for years and in the end, they risk an amputation. Our antibiofilm approach can be a game changer for them.

Our second indication is respiratory, with cystic fibrosis.

There is a huge advantage in targeting bacterial biofilms, because with our pure antibiofilms we complete and not compete with existing products. The problem with all the new antibiotics is the market access, they are indicated as drugs of last resort, meaning low sales and low revenues for the pharmaceutical industry. The advantage of our dedicated antibiofilm drugs is obvious: our antibiofilms will be indicated as first intention, meaning blockbuster revenues, and more, they will be associated with antibiotics, by nature limited to their « anti-planktonic profiles ». We are developing drugs that the physicians need!

 

We aren’t targeting niche indications like new antibiotics have to and we can thus target broader indications which can benefit to a lot of patients. The WHO admitted earlier this year a note that supports our strategy: there is not enough founding to tackle antimicrobial resistance and when there is, they are not focused enough on ESKAPE.

It’s good you speak about financing, how is it going so far for BioFilm Pharma?

This is the key element for all startup developing drugs. We are lucky enough to be backed our historic investors. Nevertheless, they can fund alone the whole development, and this is why we are engaged in a Serie A fund-raising of EUR 22M to bring our leads up to phase 2 (for DFU only), in 2024. With our strategy and surrounded by our team of experienced consultants, I have no doubt for our success.

3Biotech’s consultants help you cope with CMC. What does CMC represent to you?

It’s a question of skill. 3Biotech fills the gap between a drug candidate coming from a R&D process and a drug ready for a first in man. At BioFilm Pharma, we have the experience and competences to identify a compound as interesting and qualify it as a drug candidate. 3Biotech is the good partner for the regulatory process, the CMC and the preclinical, to drive a candidate that can be tested in humans.

As early as possible during your development, you have to follow guidelines not to bring a blind spot that could cost you a lot too far. DIY, improvisation, amateurism are banned in this kind of activity.

You said earlier that you have consultants that help go through your development. How 3Biotech helps you?

Anticipation. As I said, our job at BioFilm Pharma is to do R&D and 3Biotech helps us optimize the specifications of CMC and optimize our odds to produce a drug that can receive a market access. In the end, I’m a researcher and so my teams. We need to be surrounded by CMC sourced professionals.

They also allow us to qualify our CMC partners early, before we reached the drug candidate. This is again what I mentioned before, anticipation. They give us access to a large number of competences and industrial partners that we consulted as early as possible, when our screening phase was launched.

Eventually, Olivier Favre-Bulle, the CEO, joined the board of BioFilm Pharma, and this is a major asset for us. Investing in a biotech is a risky bet for an investor, there are multiple reasons why the project should fail. Having someone with his experience, formerly Covance’s Europe manager, as our CMC manager, sends a reassuring and seriousness message.

In my opinion, if you develop a drug you need consulting like 3Biotech is offering as early as possible. It will be at a low rate in the beginning but will grow fast when your development moves to CMC and pharma operations.

What were your 3 major difficulties to this date?

  • Money: First one is indeed having funds in enough quantity to fulfill our objectives. On that point, I think all biotechs will agree. Olivier came with me a JP Morgans conference at San Diego last year, to support me,
  • Skills: Being surrounded by the right people. They have to be competent and by your side as early as possible. This isn’t an easy task, but once you have them, their help is priceless!
  • Being the first: we are the first to develop pure antibiofilms. This is where having experienced people by your side, that can give you both high level and precise view, is key.