BetterLife Pharma is set to commence Phase I/II IN2COVID trial of its inhaled drug candidate, AP-003, for treating Covid-19 patients in Chile.
Altum Pharmaceuticals, a BetterLife subsidiary, and Pontificia Universidad Católica de Chile received approval from the Chilean regulatory authority, Institute of Public Health of Chile (Instituto de Salud Publica de Chile), to perform the trial.
AP-003 is an anti-viral, recombinant human interferon alpha-2b (rhIFN-a2b) product.
The rhIFN⍺2b is a Type I interferon that occurs naturally and is a vital protein for the first line of anti-viral defence of the body.
Scheduled to begin next month, the randomised placebo-controlled IN2COVID trial will analyse AP-003 in two portions.
The Phase I portion will enrol healthy subjects while the Phase II part will enrol patients with early-stage Covid-19 within five days of disease diagnosis.
Subjects in the treatment arms will be given a twice-daily dose of AP-003 through a nebuliser for ten days.
IN2COVID principal investigator Dr Arturo Borzutzky said: “There are several reasons why there is a need for an effective, easy to administer, non-invasive treatment such as AP-003 for Covid-19.
“AP-003, being a Type I interferon, is a broad-acting anti-viral agent and therefore potentially could be effective in all these scenarios.”
In a preclinical trial, AP-003 demonstrated potent and comparable anti-viral activity against the Wuhan reference strain of SARS-CoV-2, as well as Alpha and Beta variants.
The company noted that additional trials are underway to confirm these data and analyse AP-003’s activity against Gamma, Delta and Lambda variants.
Apart from AP-003, BetterLife is currently focusing on developing and marketing TD-0148A and TD-010 for the treatment of neurological disorders, including depression, cluster headaches and anxiety.
A non-hallucinogenic and non-controlled psychedelic candidate, TD-0148A can be self-administered.
TD-010 is being developed to treat anxiety and does not have the addictive potential linked to benzodiazepines, the company said.