US-based Biota Pharmaceuticals has started dosing patients in its Phase IIb SPIRITUS trial of vapendavir to treat patients with human rhinovirus (HRV).
Over the next 12 months, around 150 laboratory-confirmed (HRV) infected patients with moderate-to-severe asthma will be enrolled in the trial from the US and multiple European countries.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The company intends to report top-line data from the multi-centre, randomised, double-blind, placebo-controlled, dose-ranging Phase IIb trial in mid-2016.
Allergist-immunologist and principal investigator of the SPIRITUS trial Dr Jonathan Matz said: "There are no antivirals currently approved for the treatment of HRV infection, which is a major cause of disease exacerbation among patients with asthma and COPD.
"Therefore, the initiation of this important trial of vapendavir in moderate-to-severe asthmatics is truly exciting, and based on the positive outcome from the Phase II study in mild asthmatics, I am looking forward to the data from this trial next year."
Primary endpoint of the trial is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score, while the secondary endpoints are focused on safety, tolerability and lung function assessments.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataBiota vice-president of Clinical Development Anna Novotney-Barry said: "The commencement of dosing in our SPIRITUS trial represents a significant achievement in our ongoing effort to further define the efficacy and safety profile of vapendavir in patient populations with respiratory disease, whose disease control is at risk due to viral respiratory infection."
The lung function evaluations include forced expiratory volume in one second (FEV1), incidence of asthma exacerbations, assessments of the severity and duration of cold symptoms measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) and virological assessments such as changes in viral load.
