SCALE-UP & MANUFACTURING A CLINICAL BATCH OF EXL01
The bacterial strain EXL01 is extremely sensitive to oxygen and was deemed impossible to manufacture in industrial large-scale conditions when we initiated our project.
We successfully developed a large-scale manufacturing process for the Drug Substance using industrial fermenters. We produced the first (worldwide) large-scale clinical batch of EXL01's drug susbtance in Good-Manufacturing-Practices conditions. We produced the first clinical bacth of EXL01's drug product in Good-Manufacturing-Practices conditions while maintaining strict anaerobic conditions. We pursued the development and optimizations of our industrial drug substance manufacturing process, while developing a unique manufacturing control strategy, in our newly set-up Pilot Unit Laboratory (including pilot scale fermenters)
This work allowed us to:
1- Initiate our first clinical trial to evaulate EXL01
2- Develop new secret manufacturing & control know-hows
3- Develop unique in-house expertise used to generate critical control data and optimization data for our regulatory dossier
4- Position Exeliom Biosciences as a global leader in the field of microbiome-based medicines by being the first worldwide to produce a large-scale batch of F. prausnitzii and by initiating the first clinical trial with a Live Biotherapeutic Product in Crohn's disease patients
CLINICAL TRIAL
Live Biotherapeutic Products form a novel regulatory category. It, therefore, requires multiple interactions with competent authorities to receive a clinial trial authorization.
Crohn's disease is a very competitive field when it comes to operating clinical trials. Therefore, a great deal of preparatory activities were required. The level of complexity was even brought higher by the fact that our study was a maintenance trial, when the vast majority of trials in Crohn's disease are induction trials. It means that clinical sites were less used to the type of design that we wanted to pursue.
Having this in mind:
1- We conducted Scientific Advice meetings with several national agencies in Europe. These meetings allowed us to better understand what would be required to obtain a clinical trial authorization in Europe.
2- We selected a clinical contract research organization with a good track record in inflammatory bowel diseases
3- We worked in parallel on the preparatory work for the submission of our clinical trial authorization request, and on the preparatory work for the clinical activities (selection of the site, finalization of the clinical quality documents, selection of the clinical research assistant, finalization of the protocol, etc.)
4- We activated the first clinical sites and we started to monitor the study
This work allowed us:
1- To obtain the first clinical trial authorization in Europe of a single-strain live biotherapeutic product (first worldwide with a single-strain F. prausnitzii-based product)
2- To recruit the first patient in our clinical study:
https://clinicaltrials.gov/ct2/show/NCT05542355(odnośnik otworzy się w nowym oknie)The results from the first part of the clinical trial are expected in end of 2023, and the results from the second part are expected in end of 2025.
We have activaly made our successes known from the public through communications during industry events or via our social media.
