BetterLife Pharma subsidiary Altum Pharmaceuticals and Pontificia Universidad Católica de Chile have initiated the Phase II segment of the Phase I/II IN2COVID clinical trial of the inhaled product, AP-003, to treat Covid-19.
AP-003 is an antiviral recombinant human interferon alpha-2b (rhIFN-a2b) therapy.
The Phase II trial was launched on concluding the Phase I segment, which enrolled 18 healthy participants.
Trial findings showed that AP-003 had a beneficial safety and tolerability profile without any serious side effects reported.
The randomised, double-blind, placebo-controlled Phase I/II trial is designed to assess the safety and efficacy of twice-daily inhaled doses of AP-003 for ten days.
Phase II portion will enrol a total of 150 adult patients with mild or moderate Covid-19. These subjects will be randomised into a 1:1 ratio to receive either nebulised AP-003 or a placebo two times a day for ten days.
BetterLife CEO Dr Ahmad Doroudian said: “Since interferon alpha-2b is a broad-acting antiviral agent, we believe BetterLife’s AP-003 will potentially be a very effective treatment against SARS-CoV-2 and variants of concern such as the newly emerging Omicron strain.
“Previous results from our in vitro studies have also shown BetterLife’s rhIFN⍺-2b to have potent activity against the Wuhan reference strain, Alpha (B.1.1.7, UK), the Beta (B.1.351, South Africa) and the Delta SARS-CoV-2 variant (B.1.617.2, India outbreak).”
According to in vitro data, AP-003 demonstrated anti-viral activity against the Delta variant of the SARS-CoV-2 virus, offering up to 97% protection in virus-infected human cells.
The product previously showed activity against the Wuhan strain, as well as the Alpha and Beta variants.
In July 2021, the Institute of Public Health of Chile granted approval to commence the IN2COVID study of AP-003 for Covid-19 in Chile.