ATLANTA, March 3, 2015 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) announced today 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-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 Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) and virological assessments such as changes in viral load.
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.
About Biota Pharmaceuticals, Inc.
Biota Pharmaceuticals, Inc. is a company focused on the discovery and development of products to treat serious viral respiratory infectious diseases. The Company currently has two late-stage product candidates: (i) laninamivir octanoate, which is being developed as a one-time, inhaled treatment for influenza A and B infections; and (ii) vapendavir, a potent, broad spectrum capsid inhibitor of enteroviruses in development for the treatment of human rhinovirus infected patients with underlying respiratory illnesses, such as moderate-to-severe asthma and chronic obstructive pulmonary disease (COPD). The Company is also conducting IND-enabling studies with BTA-C585, an orally bioavailable F protein inhibitor, in development for the treatment of respiratory syncytial virus infections. For additional information about the Company, please visit www.biotapharma.com.
Safe Harbor Statement
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 June 30, 2014, as filed with the U.S. Securities and Exchange Commission on September 30, 2014, and the Company's Quarterly Reports on Form 10-Q for the quarter ended September 30, 2014 and December 31, 2014, as filed with the U.S. Securities and Exchange Commission on November 7, 2014 and February 6, 2015.
There may be events in the future that the Company is unable to predict, or over which it has no control, and the Company's business, financial condition, results of operations and prospects may change in the future. The Company may not update these forward-looking statements more frequently than quarterly unless it has an obligation under U.S. Federal securities laws to do so.
Biota is a registered trademark of Biota Pharmaceuticals, Inc.
Source:Biota Pharmaceuticals, Inc.