Aeterna Zentaris has had to push recruitment plans for a phase 3 trial of a diagnostic test in children into 2023 due to delays brought on by Russia’s war in Ukraine. The company is the latest to report impacts from the conflict, as new research shows more than 4% of global trials have had to be halted or paused as a result of instability in the region.
In an update released Monday, Aeterna said that feasibility data from the company’s CRO indicated recruitment for the late-stage test of oral diagnostic solution Macrilen “may now continue until later into 2023.” The announcement came less than two months after the company said issues related to the omicron variant had initially delayed recruitment for the trial.
Macrilen is approved to diagnose childhood-onset growth hormone deficiency in adults. The company is now testing the solution in children.
“Although our expected timeline is extended as a result of the delay caused by the pandemic and geopolitical events, we are working diligently in collaboration with our partner to consider alternate sites outside of the Ukraine and Russia to mitigate the potential impact of those events on estimated trial completion dates,” said CEO Klaus Paulini, Ph.D.
As of March 16, more than 4% of global clinical trials have been axed or halted because they were recruiting in Russia or Ukraine, according to new data from the data science firm, Phesi. Zeroing in on only phase 3 trials, 6% were impacted.
Potential treatments for schizophrenia have been hit especially hard, with more than a quarter of trials testing treatments for the disease located in either of the two nations. One such company, Karuna Therapeutics, had more than half of its phase 3 trial sites in Ukraine.
As for Aeterna, Monday’s announcement was the second time in as many months that the recruitment timeline for Macrilen has been pushed back after the company disclosed “unavoidable delays” due to the omicron variant in late January. Aeterna launched a phase 3 trial in children for the solution almost a full year ago, with the hopes of expanding use of the FDA-approved test. The study was expected to enroll about 100 children.
Macrilen, which was developed in collaboration with Novo Nordisk, was approved by the FDA in 2017 and is Aeterna’s most valuable asset. The remainder of the company’s pipeline remains in the preclinical stage, including a coronavirus vaccine that is expected to launch into the clinic in the first half of 2023.
Moving forward, Aeterna says its working with Novo Nordisk to fully assess the impact on the study’s cost and timeliness.