Provention Bio Reports Positive Results From Study Of Coxsackievirus B Vaccine Candidate PRV-101

(RTTNews) - Provention Bio Inc. (PRVB) announced positive interim results from PROVENT, a first-in-human study of PRV-101, a polyvalent inactivated coxsackievirus B vaccine candidate targeting all five key CVB strains associated with type 1 diabetes autoimmunity.

In Tuesday pre-market trade, PRVB was trading at $6.50 up $0.26 or 4.17%.

Provention is developing PRV-101 for the prevention of acute coxsackievirus B or CVB infection and the potential delay or prevention of type 1 diabetes or T1D and celiac disease.

In this interim analysis, PRV-101 met the primary endpoint demonstrating that it was well tolerated in this study, with no treatment-emergent Serious Adverse Events.

PRV-101 also met the secondary efficacy endpoint as it induced high titers of viral-neutralizing antibodies against all CVB serotypes included in the vaccine in a dose- dependent fashion.

PRV-101, licensed from Vactech Oy, is designed to prevent acute CVB infections and, in individuals at increased risk due to genetic susceptibility, to prevent CVB-triggered autoimmune damage to pancreatic beta cells that often progresses to T1D and damage to intestinal cells that may lead to celiac disease.

PROVENT is a Phase 1 placebo-controlled, double-blind, randomized first-in-human study being conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland.

The interim analysis was conducted after all trial participants completed 4 weeks of follow-up after the 3rd dose (Week 12) to assess vaccine response and safety. An additional 6-month safety follow up will be conducted and final trial results are expected in the first half of 2022.