In 2008, Exeliom Bioscience co-founders demonstrated and published the anti-inflammatory properties of F. prau (Sokol H, et al.). Since this discovery, the therapeutic potential of F. prau has been widely confirmed by both researchers and their peers globally. Here are the conclusions we can draw:
F. prau is, therefore, a unique bacterial specie that plays a critical role in inflammatory bowel diseases.
Because they are lacking this bacterium, Crohn’s disease patients do not have a fair chance to fight their conditions. Increasing the level of F. prau in patients, by administering EXL01 for instance, could well be associated with longer remission periods, less need for surgery, and an overall improved quality of life.
In other words, our lead candidate EXL01, a single F. prau strain drug product aims at giving them back this fair chance to fight.
EXL01 is very simple in principle. EXL01 is a single strain of F. prau, rationally selected, cultivated, lyophilized, and encapsulated in a special entero-protected capsule designed to protect the bacteria and to release them in a targeted area in the lower end of the small intestines, where F. prau is naturally found.
But EXL01 was also very complex in practice to develop due to the technologies and the know-how it required. F. prau has naturally evolved over millions of years in our gut, and can, therefore, tolerate only very specific conditions characterized notably by a total absence of oxygen. Only a couple of years ago, it was still deemed impossible to cultivate F. prau in industrial conditions and in large quantities. Confident that this bacterium could make a real difference for patients, we decided anyway to take up the challenge of manufacturing such strains and, by doing so, to cross this frontier of science.
After a decade of intense R&D efforts, we have designed a one-of-a-kind production process to manufacture large-scale industrial batches of our F. prau strain, making sure that we ensured the best possible conditions that mimicked the gut environment to grow and protect the bacteria all the way from fermentation, harvesting and lyophilization to encapsulation.
The capsule that we use also incorporates specific technologies to target the desired area in the human gut where F. prau can participate to the best of its abilities in improving the regulation of the inflammation in the gut.
Current treatments do not meet the basic benefit/risk balance to achieve long-term remission. EXL01 is a breakthrough innovation compared to the main existing therapeutic arsenal, composed of immunosuppressants and biologics. While immunosuppressants and biologics aim at inhibiting the immune system with dramatic consequences for the patients’ safety, EXL01 is acting directly on the natural down-regulating interactions between F. prau and the patients’ immune system. Because EXL01 uses a naturally occurring strain, it is anticipated to be safer, and cheaper than current biologics. EXL01 is even complementary to existing treatments as there is no expected contraindication to combine it with current drugs.
EXL01 is currently in the final stage of development before its entry into clinics. All possible in vitro and in vivo proof-of-concepts have successfully been demonstrated. The manufacturing challenges have been broken down, and large-scale industrial batches have been successfully produced. Next steps include seeking regulatory approval to initiate our first clinical trial.
Our first clinical trial will be initiated in 1Q-2022 to demonstrate the proof-of-concept of EXL01's safety, tolerability and ability to maintain Crohn's Disease patients in remission for longer periods of time versus placebo (Figure 6)
Currently, there is no safe therapeutic options for patients to maintain themselves in remission for long periods of time. Taking immunosuppressive treatments on a long-term basis is associated with increased risks of cancer and infections and are thus avoided leaving most patients with no options.
EXL01 offers the unique advantages to administer a naturally occurring gut bacterial strain, dominant in all healthy subjects, that can trigger strong anti-inflammatory effects on a daily basis and for long periods of time with no anticipated safety risks as they will result from a natural interaction between a commensal bacterium and a host.