Another COVID-19 casualty: ‘Major delays’ for gene therapy trials for rare diseases

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Credit: Batten Hope

While the ongoing COVID-19 pandemic won’t have much of an impact on cash available for new biotech startups, it has begun to cause delays in the development of gene therapies to treat a variety of rare diseases.

That’s the consensus of industry experts who spoke in a May 26 webinar hosted by the events organizer Terrapinn, producer of the annual World Orphan Drug Congress.

COVID-19 raises specific operational challenges to rare disease clinical trials that can force delays, [uniQure’s Sander] van Deventer said, such as slow enrollment, limited access to hospitals, and missing data.

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Particularly vulnerable are trials targeting patients with a higher-risk profile; these will require specific strategies to be assessed on a case-by-case basis.

“This has certainly been true for gene therapy clinical trials,” van Deventer said, without giving examples. “Transplant trials have been almost halted because of the pandemic. And I already know of some planned clinical trials that have run into major delays.”

Related article:  Viewpoint: Human challenge trials – volunteers intentionally infected with COVID-19 – are ‘uninformative, unnecessary and unethical’

In fact, [PTC Therapeutics’ Thomas] Bols said, the COVID-19 crisis is actually an opportunity for the biopharma industry, and especially for companies pursuing cell and gene therapies.

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“If there’s one thing that makes this crisis clear, it’s the importance of innovation. A lot of companies, small and big, are frantically working to come up with a vaccine or a therapy to counter COVID-19. This really underlines the need for innovation, and the role our industry is playing to come up with a solution.”

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