Provention Bio is a small biotech company targeting several autoimmune diseases. It has two drug candidates which target T1D: teplizumab (PRV-031) and a coxsackievirus B vaccine (PRV-101). This blog is a quick update on both of them.
I've blogged many time before and you can read them here (which includes more details than are included in this blog posting):
Clinical trials done to date suggest that Teplizumab will delay the onset of T1D (the first symptoms) by about 3 years. For example, if someone has 3 autoantibodies, they have a 35% chance of having symptoms of T1D within 5 years. However, treatment with Teplizumab will change their chances to 35% but only after 8 years.
Provention has submitted this drug for FDA approval to delay the onset of T1D when used after 2 autoantibodies have been detected, but before symptoms of T1D are detected. This is the first drug to be considered for marketing approval which would change the course of T1D (insulin treats the symptoms but it does not change the underlying disease).
The approval paperwork was submitted in Nov 2020. In April 2021, the FDA identified a serious issue involving manufacturing changes impacting drug testing. After much discussion between Provention Bio and the FDA, Provention submitted more data in Feb 2022 to address this issue. The hope was that the FDA would approve it by Aug 2022. However, in June 2022 the FDA announced that the decision would be made on 17 Nov 2022. This was strictly a delay by the FDA; no additional data needs to be submitted. In Oct 2022 there would be an announcement about required labeling and post-marketing studies (if required).
So the recent change is that we will now hear the decision on approval in Nov 2022 (with a strong hint in Oct 2022) instead of in Aug 2022 as we had previously hoped. From my point of view, this is a pretty small change. There is no point in guessing if the FDA will approve it or not; in just 4 months we will know for sure.
Coxsackievirus B Vaccine Candidate (PRV-101)
Background: There is a theory that part of the trigger which causes the onset of T1D is infection by a virus. Over the years, several common viruses have been investigated as possible triggers. I've previously blogged on Polio family viruses and Rotaviruses as possible triggers for T1D. Coxsackie B viruses are another family of viruses which might be a trigger. If Coxsackie B viruses trigger T1D, then preventing infection might prevent (or delay) T1D, and we know that vaccines prevent infection. So if this theory is correct, then a Coxsackie B vaccine could prevent or delay T1D.
Provention Bio is testing a Coxsackie B vaccine in the hopes that it will prevent or delay T1D, and in March 2022 they announced the results of their phase-I study. The two key findings were:
- There were no major adverse effects (ie. no bad side effects).
- Six months after treatment, between 90% and 100% of the people who received a high dose of vaccine had strong immunity to Coxsackie B viruses.
This is the official word on the future of this research: "The Company is currently exploring partnership opportunities to further the clinical development of PRV-101." My translation of this sentence is (very roughly) "The results were good, but we don't have enough money to run a phase-II trial for a vaccine, so we need to partner with someone who does."