Open Orphan PLC (AIM:ORPH, OTC:OPORF) hailed the progress of drug developer Bavarian Nordic, which was granted a US Food & Drug Administration breakthrough therapy designation that will effectively fast-track its respiratory syncytial virus (RSV) vaccine candidate.
The London listed research group said its hVIVO subsidiary carried out the phase II human challenge study on Bavarian Nordic’s treatment, MVA-BN 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,” said Open Orphan chairman, Cathal Friel.
“This highlights a major benefit of human challenge trials, in that they enable drug developers to obtain phase II/IIa 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."