Provention Bio, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to a novel therapy for the prevention or delay of clinical Type 1 diabetes in individuals at risk of developing the disease.
The novel therapy, PRV-031, also known as teplizumab, is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception and prevention of Type 1 diabetes (T1D).
The drug has been studied in multiple clinical studies involving more than 1,000 subjects with more than 800 patients. In previous studies of newly diagnosed patients, PRV-031 has consistently demonstrated the capability of preserving beta-cell function and reducing the need for exogenous insulin usage.
The FDA’s BTD program is designed to expedite the development and review of therapeutic candidates intended to treat serious or life-threatening diseases.
The FDA decision on BTD was based on clinical data from the “At-Risk” Study conducted by TrialNet, which showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of clinical T1D, as compared to placebo, by a median of at least 2 years in children and adults considered to be at high risk of developing clinical T1D.
“We are pleased that the FDA recognizes the transformative potential of PRV-031 in T1D, and we are committed to working with the Agency to bring this candidate to patients as quickly as possible,” stated Ashleigh Palmer, CEO of Provention Bio. “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. ”
With this designation in place, Palmer says the company plans to leverage the drug’s landmark data, as well as the robust safety database from prior teplizumab studies, to support a registration filing.
“We look forward to discussing next steps with the FDA and providing an update on the process in the coming months,” said Palmer.
- Provention Bio. (2019, August 5). Provention Bio Announces Breakthrough Therapy Designation for Teplizumab (PRV-031) for the Prevention or Delay of Clinical Type 1 Diabetes in At-Risk Individuals. PR Newswire. Retrieved from https://www.prnewswire.com/news-releases/provention-bio-announces-breakthrough-therapy-designation-for-teplizumab-prv-031-for-the-prevention-or-delay-of-clinical-type-1-diabetes-in-at-risk-individuals-300896064.html