Sanofi moves patients out of Ukraine warzone to preserve MS trials

 Sanofi has moved clinical trial patients out of Ukraine, as European pharma companies scramble to maintain their multiple sclerosis studies in the wake of the conflict brought on by the Russian invasion. 

About 11% of Sanofi’s study sites for its MS molecule tolebrutinib are in Ukraine and Russia, John Reed, global head of research and development, said on an April 28 earnings call.

The French pharma company’s teams on the ground have made “really heroic efforts” to move patients from the study out of Ukrainian territories affected by the conflict, and to the relatively safer west of the country or into clinical sites in neighboring countries, Reed said.

“We’ve taken mitigation efforts as well to expand recruitment outside those territories to add extra patients in case we lose some data,” Reed said. “But so far so good, I would say, and we are still on track with the submissions that we’ve shared previously.”

Paul Hudson, CEO of Sanofi, said on the call that it was a “Herculean effort” by everybody involved to make sure patients received the attention they need and the trials were kept on track.

In an earnings release on the same day, Sanofi said it was activating new clinical sites and expanding patient enrollment in geographies not impacted by the war. “This may lead to the planned primary completion dates of pivotal trials in MS and COPD to shift [but] previously communicated submission timelines remain unchanged,” the company said.

Fellow European Big Pharmas Novartis and Roche also revealed in their earnings calls this week that they have taken measures to insulate their MS trials from the conflict.

For the global study of Novartis’ BTK inhibitor remibrutinib, the percentage of patients located in Russia or Ukraine was in the low to mid-teens, Vas Narasimhan, CEO of Novartis, said on an April 26 earnings call.

“At the moment we believe we can fully mitigate the patients required from those two countries,” Narasimhan said. “No patients in our … studies have been enrolled so far, and so we’ll simply reallocate to other markets and we expect to remain on track.”

The previous day, Roche Pharmaceuticals’ CEO Bill Anderson revealed that the company had to open new sites in other countries to continue its late-stage trials of Ocrevus and the investigational BTK inhibitor fenebrutinib.

https://www.fiercebiotech.com/biotech/sanofi-moves-ms-patients-out-ukraine-big-pharma-tries-preserve-trials