Vertex guns for virtual trials but hits pause, sees delays for 'some new study starts'

Vertex Pharma
(Vertex Pharma)

Vertex is keeping mum on exact details but, as with the rest of its biopharma peers, is seeing trial disruption due to the COVID-19 pandemic.

In an update Friday, Vertex said: “For ongoing studies, Vertex is working with clinical trial sites to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.

“Depending on the disease, stage of development and type of study, and to reduce the burden on the healthcare system at a time of critical need, Vertex will temporarily pause enrollment in certain studies and may delay some new study starts.”

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It’s not telling just what trials are affected, but it currently has a number of pipeline drugs in early- to midstage tests, from phase 2 cystic fibrosis (CF) hopeful VX-561, an altered form of its approved CF med Kalydeco, to combo treatment VX-121 plus Tezacaftor plus VX-561.

Outside of CF, Vertex is working on an NaV1.8 inhibitor in pain as well as early-stage efforts in sickle cell disease, kidney disease and other rare disorders. There are also ongoing postmarketing tests, aka phase 4 trials, for its approved CF meds.

Jeffrey Leiden, M.D., Ph.D., chairman, president and CEO of Vertex, said: “The COVID-19 pandemic is a rapidly evolving global health crisis that will require unprecedented utilization of health care resources that we expect will have an impact on our clinical trials.

“In order to ensure patient safety and the appropriate use of healthcare resources and to maintain study integrity, we have made proactive changes to some of our ongoing and planned clinical trials. Given the rapidly evolving pandemic, it is too early to precisely determine the long-term effects of the outbreak on trial timelines.”

It follows the likes of Pfizer, Eli Lilly, Intercept and others that have to had to pause trials, some of them potentially worth billions of dollars, amid COVID-19 and resulting lockdown policies enacted across the world.

The FDA has recently urged companies to go virtual if they can, as Vertex appears to be leaning toward, using telehealth and telemedicine tech.  

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