AUSTIN, Texas--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today provided an update on the impact COVID-19 has had on two of the Company’s clinical studies in cystic fibrosis (CF). Due to the COVID-19 pandemic, and out of an abundance of caution for people living with CF and clinical study staff, enrollment has been terminated in the Phase 3 AVAIL and the Phase 2a ENCORE studies. With patient safety at the forefront of the decision, and in accordance with guidelines established by the U.S. Food and Drug Administration (FDA), efforts will be made to allow enrolled patients to continue with study treatments and site visit protocols, where possible.
The AVAIL study is evaluating AeroVanc (vancomycin hydrochloride inhalation powder) in people living with CF who have methicillin-resistant Staphylococcus aureus (MRSA) lung infection. Total target enrollment was 200 patients. Enrollment in the adult population is complete, with 55 patients out of a target of 50 enrolled. In the primary analysis population (younger patients between 6-21 years of age) a total of 133 patients out of a target of 150 are enrolled. On March 12, 2020, the Company announced it would continue enrollment of the primary analysis population until Q2 2020. In light of the current pandemic, the Company stopped enrollment earlier than anticipated. Top line results are still expected in early 2021.
The ENCORE study is evaluating Molgradex (inhaled human granulocyte-macrophage colony-stimulating factor, or GM-CSF) in nontuberculous mycobacterial (NTM) lung infection in people living with CF. Total target enrollment was approximately 30 patients and 14 patients are currently enrolled. Due to the exploratory nature of this study, data from the enrolled patients are expected to provide valuable information on the safety, and potential efficacy, of Molgradex in this patient population.
The Company has not experienced disruptions to the planning of a second Phase 3 study of Molgradex for aPAP and continues conversations with the FDA regarding study design and endpoints. Additionally, while the Company has not had any supply chain or manufacturing disruptions due to the current COVID-19 pandemic, the situation is being monitored regularly. With a continued and prolonged health crisis, an interruption could occur.
“COVID-19 has profoundly affected the healthcare sector, including clinical studies,” said Rob Neville, Chief Executive Officer, Savara. “The health and safety of our patients, and the communities in which we operate, are our highest concern. To mitigate any additional risk to people living with CF, who face an increased risk of serious complications from COVID-19, we are halting enrollment in the AVAIL and ENCORE studies. For patients continuing in the studies, we are following guidance from governing bodies regarding clinical study conduct and we remain in close contact with our sites and investigators to monitor this evolving situation.”
Savara is an orphan lung disease company. Savara’s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara’s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara’s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).
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 that efforts will be made to allow enrolled patients to continue with study treatments and site visit protocols where possible; that topline results in the AVAIL study are expected in early 2021; statements regarding the expectations for the data from the ENCORE study; that Savara continues conversations with the FDA regarding study design and endpoints for a second Phase 3 study of Molgradex for aPAP; that an interruption in the Company’s supply chain or manufacturing could occur with a continued and prolonged health crisis; that we are following guidance from governing bodies regarding clinical study conduct; and that we remain in close contact with sites and investigators to monitor the evolving situation. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the outcome of our ongoing and planned clinical trials for our product candidates, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to successfully develop our product candidates, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex and AeroVanc that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional equity capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.