Merck KGaA Overcomes Ukraine Disruption To Keep MS Frontrunner On Track
The German group is optimistic evobrutinib can be a blockbuster in multiple sclerosis and has adapted its pivotal trial to cope with disruption caused by the war in Ukraine
Merck KGaA is still on track to produce Phase III results from its multiple sclerosis drug evobrutinib in late 2023, which would keep it ahead of a crowded field of Bruton’s tyrosine kinase (BTK) inhibitor pipeline competitors.
The drug is also the most advanced candidate in its pipeline and carries with it the hopes of the German company’s near-term growth ambitions. But the company has had to think fast in the face of disruption caused by the ongoing Russian invasion of Ukraine, where many of the trial’s patients were enrolled.
Speaking at a capital markets day meeting on 6 October, Merck’s pharma chief Peter Guenter expressed confidence in the late 2023 timing of the readout, despite the huge upheaval caused by war in Ukraine.
That would then allow it to file in early 2024, and potentially set Merck up for a first-to-market launch within a year.
The company’s Phase III EVOLUTION RMS clinical trial program is evaluating evobrutinib, a BTK inhibitor in patients with relapsing MS.
The global randomized study has over 700 recruitment sites worldwide, with 16 of these in Ukraine. These include regions in the south and east of the country which have become frontlines in the conflict and occupied by Russia, including cities such as Kharkiv and Odessa.
“We have faced significant headwinds with the Ukraine situation,” said Guenter. “Our teams have been able to do a fantastic job in keeping the integrity of the data but not only that, changing the protocol to be an event-driven protocol.”
The study, which began enrolling in 2020, compares evobrutinib with Sanofi’s Aubagio (teriflunomide) in participants with relapsing MS and its primary endpoint is the annualized relapse rate (AAR).
Updates to the protocol include extending the original timeframe from 96 weeks to 156 weeks and the company has agreed with the US Food and Drug Administration to switch to an event-driven rather than timeframe-based protocol. It is hoped this will maintain the integrity of the trial and also help avoid a delay to the readout.
Changes to the number of MRI tests required in the study have also been agreed, moving from regular scans to monitor for characteristic brain lesions to “all available” scans. However Merck said these changes reflected more flexible approaches to MS trials rather than any scarcity of MRI scans.
Following Russia's invasion in late February, Merck has also decided to add extra patients outside of the affected counties, with recruitment now underway.
“Look, [the Russia-Ukraine situation] has been a rollercoaster. We’ve managed and we're very confident about the data,” added Merck’s R&D leader Danny Bar-Zohar.
“We recently had a very good dialogue with FDA regarding the quality of the data that comes from there and we are strongly committed to the readout before the end of next year.”