Provention Bio Inc (NASDAQ:PRVB) soared Monday, a day after revealing that a single course of the company’s drug PRV-031 (teplizumab) delays the onset of Type 1 diabetes in high-risk individuals by at least two years.
The Oldwick, New Jersey, company presented encouraging data from its At-Risk study at the American Diabetes Association annual meeting.
Shares in Provention Bio more than doubled, to $11.28 per share, in pre-market trade.
The study enrolled 76 participants aged 8 to 49 who were at risk because they had two or more T1D autoantibodies and “abnormal glucose metabolism,” said the company. At least 72% of the participants were under 18. The subjects were randomized to receive either PRV-031 or a placebo.
Results from the study showed that a single 14-day course of PRV-031 "significantly delayed" the onset and diagnosis of clinical T1D, as compared to placebo, by a median of 2 years in children and adults considered to be at high risk, reported the company.
The median time to clinical diagnosis of T1D for placebo participants was just over 24 months. In comparison, the median time for PRV-031 treated participants to clinical diagnosis of T1D was just over 48 months.
"This groundbreaking study demonstrates that we can use immunotherapy, specifically PRV-031, to prevent or significantly delay the onset of clinical Type 1 diabetes by at least two years in individuals who will almost certainly progress to clinical disease," said Dr Eleanor Ramos, chief medical officer at Provention Bio.
Ramos said approximately 60% of subjects in the study did not develop T1D following only one course of PRV-031 therapy, “double the placebo group.”
“Teplizumab is the first immune modulator to show a delay in the clinical onset of type 1 diabetes," said Ramos.
Meanwhile, Dr Kevan Herold, Professor of Immunobiology and Medicine at Yale University, who is the lead author of the study, said the results have “real clinical meaning” for individuals at-risk of developing clinical type 1 diabetes such as “family members of patients.”
“Delaying the onset of clinical T1D may mean the disease burden could be postponed to a point at which patients are better able to manage their disease such as after infancy, elementary school, high school or even college,” pointed out Herold.
Contact Uttara Choudhury at [email protected]