hVIVO PLC said it worked on a flu drug that has been granted Fast Track and Breakthrough Therapy designations by the US Food and Drug Administration (FDA).
The specialist contract research group said it carried out the phase IIa human challenge study to assess the potential efficacy of SAB Biotherapeutics' (NASDAQ:SABS) investigational therapeutic for seasonal influenza, SAB-176.
The FDA designations 'expedite' the development and review of medicines for serious or life-threatening conditions.
Data from the successful hVIVO-conducted evaluation contributed "significantly" to achieving the designations, the company told investors. SAB-176 is an immunotherapy that neutralises Type A and Type B influenza viruses.
Alex Mann, senior director of clinical science at hVIVO, said: "The broad-spectrum efficacy of SAB-176 was demonstrated in our phase IIa human challenge study against an influenza strain not specifically targeted in the manufacturing of the therapeutic.
"The clinical efficacy data formed an integral part of the package enabling the FDA's decision and underlines the value of rapid efficacy data achievable only through human challenge trials."
He added: "Validation of a candidate's clinical potential and the expedited review process can be a key inflexion point for the asset and company value, particularly for biotechnology clients like SAB Biotherapeutics (NASDAQ:SABS). I look forward to monitoring SAB-176's progress as it advances through later-stage clinical development."