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February 25, 2022

How Russia's invasion of Ukraine could affect 200+ clinical trials

Daily Briefing

    Earlier this week, Russia invaded Ukraine, which, in addition to creating geopolitical and humanitarian concerns, could also impact the health care ecosystem in the form of delayed clinical trials and research projects.

    How clinical trials could be affected

    There are around 2,500 public medical facilities in Ukraine that have previously run international clinical trials, and there are typically around 500 ongoing trials each year, FierceBiotech reports.

    According to FDA's clinical trials database, there are 251 drugs and devices actively being tested in Ukraine. And according to GlobalData's clinical trials database, there are over 1,000 ongoing and planned drug clinical trials in Ukraine, including 786 in the realm of oncology alone.

    Many large pharmaceutical companies have trials ongoing in the country. GlaxoSmithKline has 27 clinical trial sites in Ukraine, including its phase 3 study of otilimab in rheumatoid arthritis patients, and AstraZeneca has up to 20 active trial sites in Ukraine. Karuna Therapeutics on Thursday warned that its second phase 3 study of its drug KarXT, which is used to treat schizophrenia, could be delayed.

    "While our clinical trial sites in the Ukraine continue to actively recruit and treat patients, if political or civil conditions require it, our sites may need to delay or suspend clinical trial activities," Karuna said in a regulatory filing. "Our clinical trial sites have contingency plans in place as part of their standard quality management practices for circumstances such as these and are prepared to initiate such plans when and if necessary."

    Meanwhile, Merck's phase 3 trial of its drug Keytruda, used in combination with Lenvima in endometrial carcinoma patients, has 11 of its 195 study locations in Ukraine.

    In addition, six of Regeneron's 143 locations that are part of its phase 3 trial studying its drug Libtayo in combination with doublet chemotherapy in non-small cell lung cancer patients are located in Ukraine.

    How biotech companies could be affected

    Biotech companies could also see effects from Russia's invasion of Ukraine. Enamine, a company that has a library of millions of building block modules used by the biotech industry in research and development projects, is located in Ukraine.

    One executive at a venture-backed biotech company who spoke to Endpoints News anonymously, called Enamine "a vital part of this ecosystem," but added that, for companies that have already settled on a molecule, "there's not going to be much impact. It's really going to be in the discovery stage. That's where there's going to be an impact."

    "Pretty much everybody orders from them at one time or another," said Derek Lowe, a medicinal chemist. "It would not be enjoyable to lose them, but it would not be crippling."

    Michael Gilman, CEO of Arrakis, a startup company that is developing small molecules that bind to RNA, said his company doesn't just rely on Enamine, but a number of suppliers in Russia and Ukraine.

    "So there is definitely a level of wariness here," he said. "Backup options [are] being identified … [It's] all good until it isn't." (LaHucik et al., FierceBiotech, 2/24; Castañeda, Clinical Trials Arena, 2/24; Mast, Endpoints News, 2/24)

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