- Having reached a sufficient number of clinical centers, Phase II clinical trial testing the antibiotic candidate DNV3837 in Clostridioides (Clostridium) difficile infections will start this summer in the United States and Germany
- This trial will be conducted as part of an active Investigational New Drug (IND) authorization and a recently updated version of the clinical protocol
- The production of the first commercial batch of DNV3837 has been successfully initiated
DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics and nutrition, announced that all the conditions are in place for the upcoming start of the Phase II trial testing the antibiotic candidate DNV3837 for the treatment of Clostridioides difficile infections.
DNV3837 is a first-in-class antibiotic candidate targeting the treatment of Clostridioides difficile infections (CDIs), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections. DNV3837 has demonstrated a promising efficacy profile, and acceptable tolerance in Phase I trials. It has obtained a QIDP designation and a Fast Track status.
DNV3837 will now enter Phase II trial for the treatment of CDIs. The clinical protocol has recently been adjusted and allows the trial to be conducted under the IND initially granted for the compound.
This multicentric open-label trial will be conducted both in Germany and the United States. Under the updated protocol, the number of sites, necessary for the implementation of its Phase II, has been reached. The inclusion of the first patient is planned for mid-2019. Medpace (Nasdaq: MEDP) was chosen as the Clinical Research Organization to oversee the trial.
In parallel, DEINOVE has started the production of the first DNV3837 batch on a commercial scale, in accordance with good manufacturing practices. This batch will be used in order to prepare enough material for conducting Phase III trial. CMC (Chemistry, Manufacturing, and Controls) operations in the United States have been contracted to a recognized CMO and the first production steps have been successfully completed in accordance with the agreed specifications.
Georges GAUDRIAULT, Scientific Director of DEINOVE, states: "Clostridioides difficile infections represent a pathology associated with a strong medical need. There is no efficient and approved IV drug for the treatment of severe CDIs. This is the reason why the investigation centers selected for this trial are extremely committed and motivated by the start of this trial - they are well aware of the need at stake. In addition, with the start of the production of the first commercial batches, we are now ready for the next development stages."
The Clinical & Laboratory Standards Institute (CLSI) recently changed Clostridium difficile’s name to Clostridioides difficile. The Centers for Disease Control and prevention (CDC) have since adopted this new classification.
"Fast Track" status facilitates the development of the molecule through a faster and more flexible regulatory review of the application. This status is granted by the FDA to drugs under development that meet critical and unmet therapeutic needs.