The DSMB* considered that the benefit/risk balance of antibiotic therapy with DNV3837 was in favor of continuing the clinical trial
The design of the second part of the trial has been modified to integrate the investigators' feedback
DEINOVE (Euronext Growth Paris, ALDEI), a French biotech company, pioneer in the exploration and exploitation of bacterial biodiversity to address the urgent, global challenge of antibiotic resistance, announced today that the independent Data Safety Monitoring Board (DSMB) has completed its review of the safety data from the first part of the Phase II clinical trial of DNV3837 in the treatment of Clostridioides difficile infection (CDI). The DSMB considered that the benefit/risk balance of antibiotic therapy with DNV3837 was in favor of continuing the recruitment in this trial.
The experience acquired during this first part of the study has made it possible to improve the trial protocol, with a reduction in dose by a factor of 4 and a reduction in the duration of administration by a factor of 2, reducing the intravenous treatment from 12 to 6 hours per day. This improvement simplifies the management of the trial for the investigating physicians and their teams.
The second part of the study will be conducted in an “open-label” manner, as DNV3837 is administered intravenously, while the standards of care are administered orally. Thus, all patients included in the trial (40 in total) will receive DNV3837.
To improve patients inclusion in the trial, it was decided to rapidly open new centers in addition to those active in the United States.
Dr. Yannick Plétan, DEINOVE's Medical Director, commented: “This favorable opinion from the DSMB is an important step for the development of DNV3837. We are very proud to bring a potential solution to this high medical need disease.”
“We have been delayed by the COVID 19 pandemic during the first part of the trial. The upcoming opening of new centers and an easier protocol for investigators should simplify recruitment” concluded Alexis RIDEAU, Chief Executive Officer of DEINOVE.
* The Data and Safety Monitoring Board (“DSMB”) is an independent group of experts responsible for monitoring the patient safety data of a clinical trial, and when appropriate, balancing it against the efficacy data. It may make recommendations regarding the continuation, modification or discontinuation of the trial.