The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for a vaccine candidate for respiratory syncytial virus (RSV).
Bavarian Nordic’s MVA-BN RSV was granted the designation, which is designed to expedite the development and regulatory review of medicines to treat a serious condition, based on preliminary clinical evidence indicating that the vaccine candidate may demonstrate substantial improvement over available therapies.
Open Orphan subsidiary hVivo, conducted a Phase 2, double-blinded, placebo controlled human challenge trial to assess the vaccine candidate. That study provided a significant portion of this preliminary evidence.
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).