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Data from PrEP Biopharm's Ph. IIa clinical studies
Data from PrEP Biopharm's Ph. IIa clinical studies.
About this update from Hvivo Plc
[{"type":"text","content":"\n \nRNS Number : 3988W hVIVO plc 09 February 2017 \n\nFor immediate release 7.00am: 9 February 2017\n \nHVIVO PLC\n(\"hVIVO\" or the \"Company\")\n \nhVIVO announces data from two Phase IIa clinical studies to further profile\nPrEP Biopharm's PrEP-001 as a potential prophylactic against the common cold\n \nhVIVO plc (AIM: HVO), a specialty biopharma company with discovery and clinical testing capabilities, announces data from two exploratory Phase IIa studies of PrEP Biopharm's PrEP-001 as a prophylactic against the human rhinovirus 16 (HRV-16), a pathogen associated with the common cold. hVIVO holds a significant equity stake in PrEP Biopharm Limited, a UK biotech company developing drugs to treat respiratory infectious disease. PrEP-001 is a novel, nasally administered, broad-spectrum agent designed to leverage the body's innate immune system to prevent respiratory tract viral infections. Following the previously reported positive proof of concept studies in healthy volunteers challenged with influenza (2016)1 and HRV-16 (2014), these additional Phase IIa studies were designed to further profile PrEP-001 in a specific patient population, namely people with asthma, and to explore optimal dosing schedules. \n \nHighlights\n \nStudy PrEP-CS-002\n· Double-blind, randomised, placebo controlled study, conducted in 40 patients with mild-moderate controlled asthma challenged with HRV-16\n· The primary endpoint was a patient assessed Total Symptom Score (TSS)2, and a statistically significant difference compared to placebo was not met in the intent to treat (ITT) population\n· However, there was a statistically higher number of patients who had no symptoms (zero TSS) in the active group (5/19, 26.3%) compared to the placebo group (0/20, 0%) (Fisher Exact Test, p=0.002), suggesting a strong responder subgroup was present3\n· In addition, analysis of a modified ITT, which excluded two significant outliers, showed that the TSS peak was significantly lower in the active compared to the placebo group (p=0.031)\n· Further analysis of this subset of responders to fully characterise the observed results will be undertaken to determine next steps \n·&nbs...