Covis Pharma B.V. Initiates Phase 3 Clinical Trial of Alvesco (Ciclesonide) Inhaler for the Treatment of COVID-19

U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) filing to study the use of Alvesco in COVID-19

Study will evaluate the Safety and Efficacy of Alvesco in the Treatment of Non-hospitalized COVID-19 Patients Aged 12 and Above

LUXEMBOURG and ZUG, Switzerland, May 19, 2020 /PRNewswire/ -- Covis Pharma B.V. today announced the initiation of a Phase 3 clinical study to assess the safety and efficacy of its asthma drug Alvesco (ciclesonide) in non-hospitalized patients 12 years of age and older with symptomatic COVID-19. Patient recruitment for the multicenter, randomized, double-blind, placebo-controlled study of Alvesco is underway. The study is being initiated after FDA approval of the company's IND filing for Alvesco for the treatment of COVID-19.

"There is promising scientific evidence that Alvesco, an inhaled glucocorticoid, may both reduce COVID-19 symptoms and suppress viral replication," said Michael Blaiss, M.D., Clinical Professor of Pediatrics, Medical College of Georgia at Augusta University in Augusta, Georgia. "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."

"We are committed to rapidly evaluating Alvesco as a potential treatment for this serious global health threat," said Michael Porter, CEO of Covis. "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."

Alvesco is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. It is currently under evaluation in clinical trials for the treatment of COVID-19 in countries such as Australia, Japan, South Korea, Sweden, the UK, and now the U.S. Covis is working with key stakeholders to make the appropriate supply of Alvesco available for these clinical investigations by supporting research efforts and donating Alvesco inhalers.

"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," said Aziza Johnson, Executive Vice President of Regulatory and Scientific Affairs at Covis. "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."

The Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of Alvesco, a metered-dose inhaler, in non-hospitalized individuals with COVID-19 aged 12 and above. The study will enroll 400 patients at multiple clinical trial sites across the United States. Patients will be randomized in a 1:1 ratio to receive treatment with 320 µg of an Alvesco metered-dose inhaler twice daily plus standard supportive care, or to receive placebo plus standard supportive care. The primary efficacy endpoint is the percentage of patients with a hospital admission or death by day 30. Early results of the Phase 3 clinical study are expected to be released in late-August/early-September 2020.

There are currently no antiviral drugs approved by the FDA for COVID-19 with the exception of, Gilead's Antiviral Remdesivir has received FDA Emergency Use Authorization for the treatment of COVID-19. According to the website of the Centers for Disease Control and Prevention (CDC), clinical management of COVID-19 includes prompt implementation of recommended infection prevention and control measures in healthcare settings and supportive management of complications. See CDC Clinical Guidance for COVID-19 for more information. The World Health Organization (WHO) advises that people of all ages can be infected by the new coronavirus (2019-nCoV). Older people, and people with pre-existing medical conditions (such as asthma, diabetes, heart disease) appear to be more vulnerable to becoming severely ill with the virus. WHO recommends people of all ages to take steps to protect themselves from the virus, for example by following good hand and respiratory hygiene.

About Alvesco
Alvesco (ciclesonide) Inhalation Aerosol is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. Alvesco Inhalation Aerosol is an inhaled glucocorticoid with a small particle size (1-2 μm) enabling it to reach areas of chronic inflammation in both the large and small airways. Alvesco is not indicated for the relief of acute bronchospasm. Alvesco is not indicated for children under 12 years of age in the U.S. or under the age of 6 in Canada. See full prescribing information at Alvesco.us.

About Covis Pharma 
Covis Pharma is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com. 

Disclaimer: Michael Blaiss, M.D. Clinical Professor of Pediatrics, Medical College of Georgia at Augusta University, in Augusta, Georgia, quoted in this release is a paid consultant of Covis Pharma B.V.