COVID-19 outbreak prompts Provention to pause diabetes trial

As the race toward a drug for COVID-19 heats up, some biopharma companies are feeling the heat from the outbreak. Provention Bio is one of them—the autoimmune disease player has hit the brakes on a phase 3 study for its diabetes treatment “out of an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors.”

Provention is developing PRV-031, also known as teplizumab, for the treatment and prevention of Type 1 diabetes. In the phase 3 Protect study, it had planned to test the treatment against placebo in about 300 patients with recently diagnosed disease. Now, those efforts are on hold with no clues yet as to when they’ll pick back up.

"Our decision to pause randomization of new patients into the PROTECT study follows COVID-19-related State of Emergency declarations in many countries where our study is taking place, including the United States," said Provention CEO Ashleigh Palmer, in a statement on Monday. Patients already receiving treatment will continue to do so, but no new patients will be assigned to treatment groups.

"Our decision was not based on any study-related COVID-19 infections or other safety events, but rather a preponderance of caution relating to the ongoing pandemic, and our concern for the well-being of recently diagnosed T1D pediatric patients and their caregivers," Palmer added. "The demands on medical institutions and their clinicians during this unprecedented global crisis were also a main consideration in this decision.”

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“We will continue to monitor the situation closely and will provide an updated timeline for the PROTECT study at a future date,” Palmer added.

As of Monday, the COVID-19 pandemic will not affect Provention’s other programs, the company said. That includes the rolling submission of teplizumab for the prevention or delay of Type 1 diabetes in people who are at risk of developing the disease. The company plans to file the Biologics License Application by the end of the year.

Provention’s delay comes as other companies, including BioNTech and tandem Eli Lilly and AbCellera usher COVID-19 vaccines and treatments toward the clinic. More companies may follow its lead, but so far, analysts figure it’s too early to say what impact the pandemic might have on non-COVID-19 clinical trials.

“Last week, over ~1,400 new trials were posted… This implies both that folks are showing up to work and (presumably) no decision by leadership to delay new trials,” wrote Bernstein analyst Ronny Gal on Monday.

From conversations with CEOs of biopharma companies running cancer studies, BTIG analysts concluded that “it’s truly too early to know the impact COVID-19 will have in the U.S., but ongoing trials and patients already started on treatment should be the least impacted.”

Editor's note: This story was updated to clarify that Provention paused the randomization portion of the study.