Covis Pharma’s Alvesco (ciclesonide) Inhaler Enters Phase III COVID-19 Trials

“Alvesco may both reduce COVID-19 symptoms and suppress viral replication.”

Covis Pharma’s inhaled glucocorticoid, Alvesco (ciclesonide), has entered a US multicentre, randomised, double-blind, placebo-controlled Phase III safety and efficacy trial in 400 non-hospitalised patients 12 years of age and older with symptomatic COVID-19. The product is delivered twice daily via a pMDI.

Michael Blaiss, MD, Clinical Professor of Paediatrics at the Medical College of Georgia at Augusta University (GA, US) said there was “promising scientific evidence that Alvesco … may both reduce COVID-19 symptoms and suppress viral replication”.

Covis CEO Michael Porter said: “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 US for the treatment of COVID-19.”

PRESS RELEASE

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 US and over six years of age in Canada. It is currently under evaluation in clinical trials for the treatment of COVID-19 in countries such as AustraliaJapanSouth KoreaSweden, the UK, and now the US 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 III study is a multicentre, randomised, double-blind, placebo-controlled study of Alvesco, a metered-dose inhaler, in non-hospitalised individuals with COVID-19 aged 12 and above. The study will enrol 400 patients at multiple clinical trial sites across the United States. Patients will be randomised 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 III 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 which has received FDA Emergency Use Authorisation for the treatment of COVID-19. According to the website of the US 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 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.

Source: OINDP.

Link to Press Release.

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