Open Orphan (ORPH ) has acknowledged a US FDA ‘Breakthrough Therapy Designation’ that was granted to the biotechnology company Bavarian Nordic earlier this month for Bavarian Nordic’s respiratory syncytial virus (“RSV”) vaccine candidate known as MVA-BN® RSV.
A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
A significant portion of this preliminary evidence was a challenge study conducted by hVIVO.
Last year, hVIVO, a subsidiary of the specialist contract research organisation (CRO), 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.
The breakthrough therapy designation awarded provides an option to work more closely with the US FDA for the development and review of Bavarian Nordic’s MVA-BN RSV candidate.
hVIVO’s study 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. Overall, the MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections, it highlighted.
No vaccine-related serious adverse events were observed with the vaccine well tolerated and consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.
RSV is a contagious, common respiratory virus that can cause 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 considered a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults.
Cathal Friel, Executive Chairman, 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.”
He said: “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.
Friel said the data to date has highlighted a major benefit of human challenge trials, in that they have enabled 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.”
He added that this important data can be used to strengthen future submissions for important regulatory programmes such as the US FDA’s Breakthrough Therapy Designation.
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