Provention Bio PRVB Stock News

Provention Bio Inc (NASDAQ: PRVB) is rocketing in the market this morning, with gains of more than 360% early on. The gains come after the company issued data suggesting that it’s product under development has the ability to delay the onset of diabetes in high-risk patients. Here’s what’s happening:

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PRVB Announces Strong Clinical Data

In a press release issued early this morning, Provention Bio said that data suggest that its product under development has the ability to delay the onset of diabetes in high-risk patients. The results came from a National Institutes of Health-sponsored “At-Risk” Study.

Results of the study were published in The New England Journal of Medicine and presented at the Scientific Sessions of the 79th Annual American Diabetes Association meeting.

Type 1 Diabetes TrialNet, a collaboration that is focused on the prevention or delay of type 1 diabetes, led the charge on the study. During the study, investigators evaluated PRV-301, a key candidate at PRVB, for the prevention or delay of type 1 diabetes in relatives of diabetics at high-risk of developing the condition.

The 76 patients enrolled in the study were considered to be high-risk for type 1 diabetes. This is because these patients had two or more T1D autoantibodies and abnormal glucose metabolism. 72% of these patients were youth, ages 8 to 17.

According to the study results, a single 14-day course of PRV-031 led to a significant delay in the onset and diagnoses of type-1 diabetes, when compared to placebo. In fact, the median delay achieved in the study came in at 2 years in children and adults alike.

The PRVB said that the median time for placebo participants to reach clinical diagnosis of T1D came in at just over 24 months. However, the median time for PRV-031-treated patients to clinical diagnosis was just over 48 months, suggesting that the treatment led to a 2 year delay in the onset of diabetes.

However, the data is even better when you look at the percentage of patients that developed clinical diabetes. In the placebo group, 72% of patients developed diabetes while only 43% of patients treated with PRV-031 developed the condition.

Moreover, the company said that the treatment proved to be safe and well tolerated across the patient population.

Management Commentary

This groundbreaking study demonstrates that we can use immunotherapy, specifically PRV-031 (teplizumab), 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. More importantly, 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. – Dr. Eleanor Ramos, Provention’s Chief Medical Officer and Chief Operating Officer.

This Is Huge News

Diabetes is becoming an epidemic in the United States and around the world. As a result, billions of dollars are being invested into finding better ways to prevent and treat the condition. To date, PRV-031 is the only treatment that has shown clinical data suggesting the ability to delay the onset of type 1 diabetes.

Considering this, the data could open a door to a massive stream of revenue for the company. With the strong data, that was the result of multiple partnerships and produced by highly decorated clinical professionals, Provention Bio may soon have the only diabetes vaccine on the market relatively soon.

Keep in mind, about 100 million Americans suffer from diabetes, and the pool of high0risk patients is even larger. Should PRV-031 be approved by the FDA, the drug could quickly become a blockbuster, returning incredible value for investors.

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The Takeaway

The takeaway here is a relatively simple on. PRVB has an asset that, if approved, has the ability to greatly increase revenue while improving the quality of life for patients at high risk of developing clinical diabetes. With the strong data in mind, chances are good that the company will achieve approval for the drug, giving those that get in early the opportunity to see incredible long-run gains!

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