BetterLife Pharma Inc (CSE:BETR, OTCQB:BETRF) said its wholly owned subsidiary Altum Pharmaceuticals Inc along with Pontificia Universidad Católica de Chile have enrolled the first patient in the Phase 1 portion of the Phase 1-2 randomized placebo-controlled (IN2COVID) trial in COVID-19 patients.
The trial is testing BetterLife’s proprietary inhaled interferon alpha-2b product, AP-003.
The IN2COVID trial consists of a randomized placebo Phase 1 portion in healthy subjects followed by a randomized placebo-controlled Phase 2 portion in early stage COVID-19 patients (less than 5 days of diagnosis).
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The IFN-α2b treatment arms will receive BetterLife’s proprietary inhaled IFN-α2b product, AP-003, administered via nebulizer, twice daily for 10 days.
"We are excited to be able to initiate this trial of AP-003 in COVID-19 patients in collaboration with the Escuela de Medicina (School of Medicine) at the Pontificia Universidad Católica de Chile,” said BetterLife CEO Dr. Ahmad Doroudian in a statement. “The team, as well as the trial center, are the leaders in Chile in conducting COVID-19 trials.”
Dr. Arturo Borzutzky, study director of the IN2COVID trial and head of Pediatric Immunology, Allergy and Rheumatology at the School of Medicine of Pontificia Universidad Católica de Chile, added: “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. These reasons include: emergence of SARS-CoV-2 variants, not knowing the duration of protection afforded by the current vaccines and the reality of breakthrough infections in vaccinated individuals.”
Dr. Eleanor Fish, one of the principal investigators of the trial, said AP-003 may be effective in all the scenarios described by Dr. Borzutzky.
BetterLife noticed that Dr. Fish, a professor in the Department of Immunology, University of Toronto, is the principal author of the exploratory trial published in 2020 in Frontiers of Immunology titled "Interferon-α2b Treatment for COVID-19", which examined the outcome of treating a cohort of 77 individuals with confirmed COVID-19 admitted to Union Hospital, Wuhan, China, with inhaled interferon-α2b.
The study revealed the therapeutic benefits of Interferon-α2b treatment in patients with early COVID-19. The company said the authors concluded that a randomized clinical trial was warranted in moderate cases of COVID-19 and "treatment with IFN-α2β may benefit public health measures aimed at slowing the tide of this pandemic, in that this exploratory study demonstrated that duration of viral shedding was shortened, and lung abnormalities and systemic inflammation were significantly reduced."
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