Open Orphan plc (LON:ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, noted today the announcement dated 14 February 2022 from Bavarian Nordic A/S (OMX: BAVA), reporting that the US Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for Bavarian Nordic’s respiratory syncytial virus (“RSV”) vaccine candidate, MVA-BN® RSV. hVIVO, a subsidiary of Open Orphan, successfully conducted a Phase 2, double-blinded, placebo controlled human challenge trial to assess MVA-BN® RSV using its RSV Human Challenge Study Model.
A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition. The designation has been granted upon the assessment of preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint. A significant portion of this preliminary evidence was the successful challenge study conducted by hVIVO. The designation provides an option to work more closely with FDA for the development and review of MVA-BN RSV.
The challenge study conducted by hVIVO to assess MVA-BN® RSV demonstrated a significant reduction in viral load in vaccinated subjects versus placebo, thus meeting the primary endpoint of the study. At the same time, vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.
RSV is a contagious, common respiratory virus that usually causes mild, cold-like symptoms and affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of infectious and respiratory disease areas, including various strains of influenza, RSV, HRV, COVID-19, asthma and malaria, etc.
Cathal Friel, Executive Chairman, Open Orphan plc, said: “We are pleased to see Bavarian Nordic achieve Breakthrough Therapy Designation for its RSV vaccine candidate, MVA-BN® RSV. hVIVO successfully conducted a human challenge trial on behalf of Bavarian Nordic in 2021, where the candidate showed a significant reduction in clinical symptoms associated with RSV.
“The data from this human challenge trial was part of the body of evidence provided by Bavarian Nordic to the FDA in order to secure its Breakthrough Therapy Designation, which could ultimately result in an expedited regulatory review of MVA-BN® RSV. This highlights a major benefit of human challenge trials, in that they enable drug developers to obtain Phase 2/2a efficacy data for their vaccine and antivirals candidates in a fast, cost-effective manner ahead of larger scale studies. This data can then strengthen submissions for important regulatory programmes such as the Breakthrough Therapy Designation.”
