Savara Receives $5 Million Award From Cystic Fibrosis Foundation Therapeutics, Inc. for the Development of AeroVanc
"We are delighted to have the
"Cystic fibrosis has been a primary focus of my research interests for many years. Inhaled antibiotics have become the standard of care to treat Pseudomonas aeruginosa lung infection and we are now on the verge of demonstrating that a similar approach should be used for MRSA. AeroVanc has shown potential as a novel treatment for MRSA lung infection, a growing problem not currently addressed by any other available inhaled antibiotics," stated Patrick Flume, M.D., Director, Adult Cystic Fibrosis Center and Professor of Medicine and Pediatrics at the
About the AVAIL Study
The AVAIL study will enroll approximately 200 subjects at more than 80 clinical study sites across
The primary efficacy endpoint in the AVAIL study is the mean absolute change from baseline in FEV1 percent predicted (Forced Expiratory Volume measured during the first second of exhalation). The primary efficacy analysis will be based on patients between 6 - 21 years of age. Secondary efficacy endpoints include: (i) time to use of another antibiotic medication (oral, IV, and/or inhaled) for pulmonary infection, (ii) the number of successful FEV1-response cycles a subject achieves over Period 1, (iii) relative change from baseline in FEV1 percent predicted, (iv) change from baseline Cystic Fibrosis Questionnaire-Revised score, and (v) change from baseline in Cystic Fibrosis Respiratory Symptom Diary-Chronic Respiratory Symptom Score.
AeroVanc (vancomycin hydrochloride inhalation powder) is the first inhaled antibiotic being developed for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals living with cystic fibrosis (CF). In a randomized, double-blind, placebo-controlled Phase II study in CF patients with persistent MRSA infection, AeroVanc reduced MRSA density in sputum, and showed encouraging trends of improvement in lung function, and respiratory symptoms, as well as prolongation of the time to use of other antibiotics, with best responses in subjects under 21 years of age.
AeroVanc has been granted Orphan Drug Designation and Qualified Infectious Disease Product, or QIDP, status for the treatment of persistent MRSA lung infection in CF patients in
Forward Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements relating to funds being available to support the continued development of AeroVanc, funds can be used to support the Company's ongoing Phase III pivotal AVAIL study of AeroVanc, planned enrollment and structure of the AVAIL study,
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