9th Feb 2017 09:41
LONDON (Alliance News) - Specialty biopharmaceuticals firm hVIVO PLC on Thursday said two phase IIa clinical studies failed to meet their primary endpoints, and now plans to undertake work to further characterise the results of the studies.
The studies were of PrEP-001, in development as a a prophylactic against the human rhinovirus 16 by hVIVO joint venture PrEP Biopharm, in which hVIVO holds a significant stake.
The first study, PrEP-CS-002, failed to show a statistically significant difference compared to a placebo on the basis of patient assessed total symptom score in 40 patients with mild-moderate controlled asthma.
However, hVIVO said there was a statistically higher number of patients who had no symptoms compared to the placebo group, which suggested there was a strong responder sub-group present.
Meanwhile the second study, PrEP-CS-003, also failed to meet a primary endpoint in patient assessed total symptom score. This study was exploring the impact of two potential dosing schedules, and there was no statistically significant difference between the two dosing schedules and placebo.
"While PrEP-CS-002 and PrEP-CS-003 did not meet their primary endpoints, these exploratory studies provide valuable insights for PrEP-001 and build on the profile of the drug following the previously reported positive proof of concept trials in flu and the common cold," said Chief Executive Officer Kym Denny in a statement.
"We are encouraged by signs of a potential treatment effect in the asthma responder subgroup for this complex respiratory disease where multiple phenotypes are recognised but not fully understood. PrEP Biopharm will now undertake further clinical characterisation of the results to inform the company's future development of PrEP-001. I look forward to updating the market on future plans later in the year," Denny said.
Shares in hVIVO were down 14% at 200.00 pence Thursday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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