Biota Commences Dosing in Vapendavir SPIRITUS Phase 2b Trial
"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.
"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
The primary endpoint of this multi-center, randomized, 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 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
About Human Rhinovirus (HRV) and Respiratory Disease
While several different viruses are known to cause upper respiratory tract infections, it is estimated that HRV causes more than 50% 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.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve known and unknown risks and uncertainties concerning Biota's business, operations and financial performance. Any statements that are not of historical facts may be deemed to be forward-looking statements, including; enrollment of 150 laboratory-confirmed HRV infected asthma patients; the time frame in which the Company may fully enroll the Phase 2 SPIRITUS clinical trial of vapendavir; the timing of top-line data from the SPIRITUS trial, and other cautionary statements contained elsewhere in this press release and in the Company's Annual Report on Form 10-K for the year ended
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Joseph M. Patti, PhD President and Chief Executive Officer of Biota (678) 221-3352 firstname.lastname@example.org Sarah McCabeStern Investor Relations, Inc. (267) 909-9237 email@example.com
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