- Provention Bio Inc PRVB has announced interim results from the PROVENT Phase 1 trial of PRV-101.
- PRV-101 is a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate targeting all five key CVB strains associated with type 1 diabetes (T1D) autoimmunity.
- Provention is developing PRV-101 to prevent acute CVB infection and the potential delay or prevention of T1D and celiac disease.
- In this interim analysis, PRV-101 met the primary endpoint demonstrating that it was well tolerated, 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.
- The interim analysis was conducted after all trial participants completed four 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 1H of 2022.
- Price Action: PRVB shares are down 0.08% at $6.24 during the market session on the last check Tuesday.
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