Novartis' cholesterol buster, new trial starts fall victim to pandemic: report

The COVID-19 pandemic has driven biopharmas left and right to hit pause on clinical trials, and Novartis is no exception. The Swiss pharma has stopped enrolling patients in a trial of its cholesterol fighter inclisiran even as it expects its trials to stay on course in the long term.

“When you look across our clinical trials portfolio, we’re actually seeing very good performance,” Novartis CEO Vas Narasimhan, M.D., told Bloomberg. “Our submissions are on track, our regulatory filings are on track, so in the coming year, so we feel like all of our key milestones will happen on time.”

The one exception, Narasimhan said, was a U.K. trial of inclisiran, the PCSK9 drug Novartis bagged in its $9.7 billion takeover of The Medicines Company last year.

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“We have had to pause enrollment in the U.K. as we wait for the system to stabilize, but we expect these to be short-term effects,” he said.

The Medicines Company wrapped the last of three phase 3 studies for inclisiran in September 2019. It is now under review by the FDA and the European Medicines Agency for the treatment of atherosclerotic cardiovascular disease, an an inherited disorder that causes high cholesterol, including in patients that have already maxed out the doses of other therapies.

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The company is turning to digital methods to manage patients and keep its trials going, but the “real issue” has been starting new studies and continuing enrollment of ongoing studies, like the one for inclisiran, Narasimhan said.

“We’re doing our best to mitigate that: we’ve been able to shift studies to China and Asia where there is the ability to enroll at a more normal pace,” he said.

China, where SARS-CoV-2, the virus behind the pandemic, originated late last year, initially saw its trials slow down, according to a report from Medidata, now owned by Dassault Systèmes. In March 2020, 68% fewer new patients started on clinical trials compared to the same month a year before, the report’s authors wrote, “but the silver lining was that March was 240% higher than February in terms of new patients added, which could be a leading indicator of China returning to normalcy.”

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The pandemic has disrupted clinical work for Novartis’ peers, including Vertex and Eli Lilly, which are both hitting pause on study enrollment and holding off on new trial starts. Pfizer announced at the end of March that it would do the same, except for studies that are enrolling people with life-threatening conditions who are running out of treatment options. Now, one month later, the Big Pharma has begun “to restart recruitment across the development portfolio, including new study starts, at all clinical trial sites that are currently operational” and where Pfizer and investigators are able to “monitor safety.”