Candidate: Alvesco (ciclesonide) Inhalation Aerosol
Type: 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 indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents ages 12 years+ in the U.S. and over 6 years of age in Canada.
Status: Covis said May 19 it has launched a Phase III trial assessing the company’s Alvesco as a potential treatment for non-hospitalized patients 12 years of age and older with symptomatic COVID-19, following IND approval from the FDA. Patient recruitment is underway in the multicenter, randomized, double-blind, placebo-controlled study, which is designed to enroll 400 patients at multiple clinical trial sites across the U.S.
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 III study are expected to be released in late August or early September, Covis said.
Covis said the company acted to evaluate Alvesco after the drug was used to treat three patients on the Diamond Princess cruise ship all of whom had positive outcomes. Since then, Covis has seen promising early results in another trial currently ongoing in Sweden—prompting the company to test the drug in the U.S. Alvesco is currently under evaluation in clinical trials for the treatment of COVID-19 in Australia, Japan, South Korea, Sweden, the U.K., as well as the U.S.
Ownership of Covis changed hands earlier in 2020, after funds managed by affiliates of Apollo Global Management acquired Covis from an affiliate of Cerberus Capital Management for an undisclosed sum.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: