The situation in Ukraine may affect more than 200 clinical trials!

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The situation in Ukraine may affect more than 200 clinical trials!

The situation in Ukraine may affect more than 200 clinical trials! Merck and many other pharmaceutical companies responded…

on February 23, Russia went to war with Ukraine, a war that could affect millions of people, not only in Eastern European countries, but all over the world.

The global biopharmaceutical industry sector will also be affected, with clinical trials in Kiev, the Ukrainian capital, and other parts of the country likely to face delays.

Geopolitical tensions are worrying, biotech Karuna Therapeutics says the timeline for the second phase 3 trial (EMERGENT-3) of the company’s schizophrenia drug KarXT is uncertain as 10 of 19 clinical trial sites one in Ukraine.

Karuna Therapeutics may not need the study to submit KarXT for approval, according to analysts at RBC Capital Markets. But Karuna Therapeutics could run into trouble if the first phase 3 clinical trial (EMERGENT-2) fails to meet its primary endpoint and generate safety data. EMERGENT-3 is a “backup option,” the analyst wrote in a note Thursday.

Karuna Therapeutics said in a regulatory filing on Thursday: “While our clinical trial sites in Ukraine are continuing to actively recruit and treat patients, our clinical trial sites may need to delay or suspend clinical trial activities if political or civil demands dictate. Our clinical trial sites have contingency plans in place as part of standard quality management practices in such situations and are prepared to initiate such plans if necessary.”

According to the clinical research organization Global clinical trials, Ukraine has about 2,500 public medical institutions with experience in conducting international trials, with about 500 ongoing clinical trials per year.

The impact of the Russian-Ukrainian conflict on clinical trials could be far-reaching. According to the US FDA’s clinical trials database, there are 251 drugs and devices in the biopharmaceutical industry that may be affected. Clinical trials of these drugs and devices involve at least one clinical trial site in Ukraine.

For example, Merck is conducting a Phase 3 trial of Keytruda in combination with Lenvima in patients with endometrial cancer involving 195 clinical trial sites, 11 of which are in Ukraine. In addition, Regeneron is also conducting a Phase 3 trial of Libtayo in combination with dual chemotherapy in patients with non-small cell lung cancer in Ukraine, involving 143 clinical trial sites, six of which are located in Ukraine.

A Merck spokesman said Ukraine and Russia account for about 1 percent of Merck’s business, and the company does not have any production sites in either country. “At this time, all of our colleagues are safe and we will continue to monitor the situation closely and provide them and their families with all the support we can,” the spokesperson said. “We are also doing everything we can in line with our mission. Make sure patients get our medicines.”

GlaxoSmithKline may also be affected, and the company is conducting a phase 3 clinical trial of the monoclonal antibody otilimab in rheumatoid arthritis (RA) involving 235 clinical trial sites, 27 of which are in Ukraine. A GlaxoSmithKline spokesman confirmed that the company has local pharmaceutical and consumer healthcare teams in Ukraine, but no manufacturing facilities. “The situation is evolving and we are monitoring it carefully,” the company said in a statement sent to Fierce Biotech. “Our absolute priority is the safety of our people and ensuring access to our medicines, vaccines and consumer healthcare products. .”.

Sanofi is also conducting at least two studies in Ukraine on its anti-inflammatory drug Dupixent in partnership with Regeneron, and the company said it was monitoring the situation. “Sanofi’s top priority remains the safety of our employees and the continuity of our service to patients,” a spokesman said. “All of our employees in Ukraine have been asked to stay home and we are closely monitoring the situation.”

Takeda also said, “The current situation is unstable, but the company is doing everything it can to protect our employees and their families and continue to provide patients with much-needed treatment.”

Behind a pharmaceutical company’s clinical trials are contract research organizations (CROs) that organize the work on site. In a statement sent to Fierce Biotech, clinical trial CRO Parexel confirmed that the company is conducting clinical trials in the affected areas. “While we will not disclose the exact number of colleagues, customers or suppliers affected, like the rest of the world, we have been and will continue to monitor the situation closely and are committed to supporting the continuum of ongoing clinical trials,” the company said. Sex. As always, the safety and well-being of patients and colleagues remains our top priority.”

Analysts at investment bank Jefferies released a report covering 45 biopharmaceutical companies, nine of which have clinical trial sites in Ukraine. Karuna Therapeutics is one of them. Another company, Veru, expects to “respond appropriately and stay on schedule” in its breast cancer treatment study because the trial has only just begun, the analyst wrote in the report.

The report states that TG Therapeutics should not be “meaningfully affected” because the company has submitted a U.S. marketing application for ublituximab for the treatment of relapsing forms of multiple sclerosis, with a PDUFA target action date of September 28, 2022. However, 20 of the 85 clinical trial sites involved in a phase 3 extension study of the drug are in Ukraine.

“Overall, we do not believe the ongoing conflict in Ukraine will have a meaningful impact on the clinical trials of drugs covered by our report,” Jefferies analysts wrote on Thursday.

Reference：

Russian invasion of Ukraine could affect more than 200 clinical trials across biotech and pharma

The situation in Ukraine may affect more than 200 clinical trials!

(source:internet, reference only)

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