Date: 2015-03-03
Type of information: Treatment of the first patient
phase: 2b
Announcement: treatment of the first patient
Company: Biota Pharmaceuticals (USA - GA)
Product: vapendavir
Action
mechanism: capsid inhibitor. Vapendavir is a small molecule inhibitor (capsid binder) that has antiviral activity against a variety of diverse enteroviruses (such as EV-71 and poliovirus). Its mechanism of action effectively stops infection by interfering with early steps in the infectious cycle.
Disease: rhinovirus (HRV) infection in patients with moderate-to-severe asthma
Therapeutic area: Infectious diseases - Respiratory diseases
Country: USA, South Africa, Germany, Romania, India and the Ukraine
Trial
details: This multicenter trial is to be conducted at approximately 60 sites among 6−8 northern hemisphere countries in North America and Central Europe. Sufficient patients will be randomized in order to recruit 150 subjects who are laboratory confirmed for human rhinovirus (HRV) infection. Depending on HRV PCR positivity rates, it is expected that randomization of 250-480 subjects will be required to achieve this number of subjects with HRV infection. Appropriate asthma subjects will be screened up to 120 days prior to presentation at the study site with symptoms of presumed HRV infection for potential study inclusion on Study Day 1. The study drug treatment period has a duration of 7 days, beginning on Study Day 1. Follow-up study visits to the clinic occur on Study Days 3, 5, 7, 14, 21, and 28 with a telephonic final safety follow-up visit conducted on Study Day 35. Thus, depending on the duration of the screening period, a subject\'s duration of participation can be estimated to last from approximately 37 days up to 155 days. The primary endpoint of this study is the change from baseline to study day 14 measured by an asthma control questionnaire (ACQ)-6 total score. The secondary endpoints are focused 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. (NCT02367313)
Latest
news: * On March 3, 2015, 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.
