BetterLife Pharma Inc (CSE:BETR, OTCQB:BETRF) announced that its wholly-owned subsidiary, Altum Pharmaceuticals Inc, and Pontificia Universidad Católica de Chile have obtained approval to conduct their planned randomized placebo-controlled trial (IN2COVID) on coronavirus (COVID-19) patients.
The trial, which was approved by Instituto de Salud Publica de Chile, is set to start in early August. It will test BetterLife’s proprietary inhaled interferon alpha-2b (IFN-a2b) product, AP-003.
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The IN2COVID trial will have a randomized placebo Phase 1 portion in healthy subjects followed by a randomized placebo-controlled Phase 2 portion in early-stage COVID-19 patients. The IFN-a2b treatment arms will receive AP-003, administered via nebulizer, twice daily for 10 days.
"We are excited to initiate this trial of AP-003 in COVID-19 patients in collaboration with the Escuela de Medicina (school of medicine) at Pontificia Universidad Católica de Chile,” CEO Dr Ahmad Doroudian said in a statement.
“The team, as well as the trial center, are the leaders in Chile in conducting COVID-19 trials,” he added.
According to Dr Arturo Borzutzky, the principal investigator of the IN2COVID trial, 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: the time it will take to vaccinate the whole population; not knowing the duration of protection afforded by the current vaccines; the emergence of SARS-CoV-2 variants; and the emergence of possible new coronavirus pandemics in the future.
“AP-003, being a Type I interferon, is a broad-acting anti-viral agent, and therefore potentially could be effective in all these scenarios,” Borzutzky added.
BetterLife Pharma Inc (CSE:BETR, OTCQB:BETRF). is an emerging biotechnology company primarily focused on developing and commercializing two compounds, TD-0148A and TD-010, to treat neurological disorders such as depression, cluster headaches and anxiety.
The company also owns a drug candidate for the treatment of viral infections such as COVID-19 and is in the process of seeking strategic alternatives for further development.
Contact the author at stephen.gunnion@proactiveinvestors.com