Covis Pharma said that it has initiated a Phase 3 of Alvesco ciclesonide MDI for the treatment of COVID-19 in US patients aged 12 and older who have not been hospitalized, with preliminary results expected in late-August/early-September 2020. According to Covis, studies of Alvesco for COVID-19 are already underway in Australia, Japan, South Korea, Sweden, and the UK.
Alvesco has been approved by the FDA for the treatment of asthma since 2008. Covis acquired US rights to the Alvesco inhaler, along with Omnaris and Zetonna nasal sprays, from Sunovion in 2017. In 2018, the company acquired non-US rights to Alvesco and the two nasal sprays from AstraZeneca.
The Phase 3 study is expected to enroll 400 patients who will receive 320 mcg of Alvesco twice daily plus standard care or placebo plus standard care. The primary endpoint is percentage of patients either admitted to the hospital or deceased by day 30.
Medical College of Georgia Clinical Professor of Pediatrics Michael Blaiss said, “There is promising scientific evidence that Alvesco, an inhaled glucocorticoid, may both reduce COVID-19 symptoms and suppress viral replication. Evaluating Alvesco in this Phase 3 clinical trial is an important step towards determining its efficacy in treating individuals who have tested positive for the virus, and we are hopeful that it will become an important tool in the world’s response to this public health emergency.”
Covis Executive VP of Regulatory and Scientific Affairs Aziza Johnson added, “Early scientific data suggest that the use of Alvesco may reduce symptoms in individuals with the novel coronavirus, potentially decreasing viral replication and therefore viral load. Given the urgent need for treatment options, we are working with expediency to assess the efficacy of Alvesco against COVID-19 and believe this study will provide us with important data around the drug’s ability to reduce duration of clinical symptoms, as well as the severity of the disease.”
CEO Michael Porter commented, “We are committed to rapidly evaluating Alvesco as a potential treatment for this serious global health threat. Having received approval from the FDA for our study design and protocol, we are pleased to initiate this Phase 3 study. Should Alvesco show positive results in the study’s primary endpoint for reduction of patients with a hospital admission or mortality by day 30, we intend to file for approval of our drug in the U.S. for the treatment of COVID-19.”
Read the Covis Pharma press release.
