Atlant Clinical has successfully completed an international, multicenter, randomised, placebo-controlled study in patients with cystic fibrosis.
The trial was conducted for an international pharma company. It engaged randomisation of 60 patients at six sites in the US, Russia, and Georgia. The patient recruitment process took 11 months, which is three months less than initially anticipated. As a result, the study was completed in 27 months versus the 30 months originally expected.
Atlant Clinical provided end-to-end clinical trial services from study start-up to study close-out in Russia and Georgia, as well as being responsible for clinical monitoring and project management in the US.
Cystic fibrosis is an orphan genetic disorder most affecting the lungs, kidneys, pancreas, liver, and intestine. Around 30,000 people suffer from cystic fibrosis in the US, with more than 75% of patients diagnosed by the age two. Cystic fibrosis in the EU occurs once per 2,000-3,000 newborns, with the rate varying in different countries.
CEO of Atlant Clinical Michael Groubman said: "We are proud of successfully completing the study in patients with cystic fibrosis and look forward to continuing our efforts in further clinical development of the drug candidate.
"Our extensive experience in orphan diseases and pulmonology enabled us to complete the study faster than anticipated. Quality of our operations was confirmed by independent study audits conducted during the trial. In this trial we also utilized our risk-sharing strategy, which fully aligns interests of Sponsors and Atlant in conducting clinical trials."