The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to teplizumab (PRV-031; Provention Bio), an anti-CD3 monoclonal antibody, for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at risk of developing the disease. 

The designation was based on data from a recent phase 2 trial in individuals considered at risk for T1D (ie, relatives of patients with T1D; N=76). Participants were randomized to receive teplizumab or placebo for 14 consecutive days; oral glucose tolerance tests were used to assess for progression to clinical T1D every 6 months. Findings from the study showed that treatment with teplizumab resulted in delayed progression to clinical T1D in these high-risk individuals. 

“The groundbreaking data from the At Risk trial showed, for the first time, the potential to delay the onset of T1D in individuals who are almost certain to develop clinical disease,” said Ashleigh Palmer, CEO of Provention Bio. “We look forward to discussing next steps with the FDA and providing an update on the process in the coming months.”

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Teplizumab is also being evaluated in the phase 3 PROTECT study to determine whether the investigational agent can slow the loss of beta cells and preserve B cell function in children and adolescents who have been diagnosed with T1D in the previous 6 weeks.

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