The protocol was approved as a phase II/III study, which includes a trial portion of the effective dose versus placebo and treatment of patients in three cohorts. Initially, 12 centers were approved, of which 6 research centers were opened in the first place. We were inspired by the growing challenge of organizing the logistics of biosamples.
The primary goal of the dose titration study was achieved in 2018/2019. Centers randomized 240 patients in the first phase during 2018 and 2019, who continued to be followed up and registered for relapses and other AEs.
Microbiological susceptibility testing was carried out in a central laboratory. During the study period, more than 3,000 microbiological cultures with the determination of resistance were performed, which, given the large number of centers and patients, was an interesting test of our logistical abilities for our team. The tasks were solved with the coordinated interaction of the staff of the centers, monitors, PMs and couriers.
In 2019-2020, the optimal dose of the drug was determined based on the interim report and the data obtained. In April 2020, 4 new centers joined the study and the second phase of a placebo-controlled study began, in which 176 additional patients were randomized at an adjusted dose.
The recruitment of 176 patients took longer due to the complicated epidemiological situation with COVID-19. After receiving the interim results of the study, it was found that the drug has a positive intermediate result in the clinical and laboratory picture in the treatment of complicated urinary tract infections caused by Pseudomonas aeruginosa, as well as other pathogens, including E. coli and Enterococcus spp.
After the completion of the 2nd stage, the Sponsor decided to suspend the clinical trial in order to study the safety of the PI at a higher concentration, since the drug showed a dose-dependent effect in preclinical studies.
At the end of 2021, a phase III study was launched to study the drug at a dose of 1200 mg: 361 patients were recruited in October 2022. Research is ongoing.
With gratitude for the received experience,
Artem Sergeenko, MD
Project Management Director at
ACCELLENA Research & Development