Biota Pharmaceuticals announced that it has commenced dosing of patients in its phase 2b SPIRITUS trial of vapendavir. The goal of the study is to enroll approximately 150 laboratory-confirmed human rhinovirus (HRV) infected patients with moderate-to-severe asthma from the United States and multiple European countries over the next 12 months and to report top-line data in mid-2016.
"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 2 study in mild asthmatics, I am looking forward to the data from this trial next year," stated Dr. Jonathan Matz, allergist-immunologist and Principal Investigator of the SPIRITUS trial.
"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," commented Anna Novotney-Barry, vice president of Clinical Development at Biota.
The primary endpoint of this multi-centre, randomised, double-blind, placebo-controlled dose-ranging study is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score. The secondary endpoints are focussed on safety and tolerability, lung function assessments such as 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.
While several different viruses are known to cause upper respiratory tract infections, it is estimated that HRV causes more than 50 per cent of all cases. Although such infections can be self-limiting colds in healthy subjects, patients with chronic lung diseases such as asthma and chronic obstructive pulmonary disease (COPD) are especially vulnerable to viral upper respiratory infections, and HRV infections have been closely associated with acute exacerbations of asthma, emphysema and COPD in susceptible individuals. Level of disease control is predictive for future adverse pulmonary risk and significant healthcare costs are associated with asthma and COPD exacerbations.