Recruitment for a type 1 diabetes trial involving young people has been paused amid the COVID-19 pandemic, it has been announced.
Biopharmaceutical company Provention Bio has been busy developing PRV-031, a type of antibody, which in the future is hoped will prevent and treat type 1 diabetes.
The plan was to test PRV-031, otherwise known as teplizumab, on 300 newly diagnosed young people. Researchers wanted to determine whether teplizumab slows the loss of beta cells and preserves cell function in children and teenagers aged between eight and 17. But the company has decided to halt recruiting more children and young people to the study “out of an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors at this critical juncture in the collective global efforts to combat the COVID-19 pandemic”.
Those who had already begun taking the drug as part of the study will be allowed to complete the treatment.
In a statement, Provention’s CEO Ashleigh Palmer said: “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.
“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 paediatric patients and their caregivers. The demands on medical institutions and their clinicians during this unprecedented global crisis were also a main consideration in this decision.”
None of the company’s other clinical and pre-clinical operations have been significantly impacted by the COVID-19 health crisis so far.
