Our most advanced product candidate is PRV-031 (teplizumab), an anti-CD3 monoclonal antibody which is being developed for the prevention, interception, or delay of type 1 diabetes (T1D). There has been no disease-modifying innovation for this life-impacting and life-threatening autoimmune disease since the development of insulin a century ago.
Provention acquired PRV-031 from MacroGenics in May 2018. This therapeutic candidate has been studied in more than 800 patients to date, and we are currently advancing PRV-031 forward in two indications:
Prevention or Delay of T1D in Individuals At-Risk of Developing Disease. Results from the At-Risk study, conducted by TrialNet and the NIH and published in the New England Journal of Medicine in June 2019, showed that a single course of PRV-031 delayed the onset of T1D, as compared to placebo, by a median of at least two years in children and adults at high risk of developing the disease. These groundbreaking results show that immunotherapy, specifically PRV-031, could be used to prevent or significantly delay the onset of clinical-stage TID in at-risk individuals, approximately 75% of whom progress to a T1D clinical diagnosis within five years.
Interception in Newly Diagnosed T1D. In prior studies of PRV-031 in newly diagnosed T1D patients, PRV-031 has consistently demonstrated the capability of preserving remaining beta cell function and reducing the need for exogenous insulin usage. We are currently enrolling patients aged 8-17 with recent onset T1D in a Phase 3 study (the PROTECT Study) to evaluate the therapeutic benefits of PRV-031.
Herold KC et al. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. NEJM. Published online June 9, 2019.
Kuhn C, Weiner HL. Therapeutic anti-CD3 monoclonal antibodies: from bench to bedside. Immunotherapy. 2016 Jul;8(8):889-906.
Hagopian W et al. Teplizumab preserves C-peptide in recent-onset type 1 diabetes: two-year results from the randomized, placebo-controlled Protégé trial. Diabetes. 2013;62(11):3901-3908.
Sherry N et al. Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomized, placebo-controlled trial. Lancet. 2011;378(9790):487-497.