BetterLife Pharma says subsidary Altum Pharmaceuticals to conduct coronavirus trial in Chile using its AP-003

BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRF) (FRA:NPAU) has announced that its wholly-owned subsidiary Altum Pharmaceuticals has entered into a Letter of Intent with Pontificia Universidad Católica de Chile to conduct a randomized, placebo-controlled trial in COVID-19 patients testing Altum’s proprietary inhaled interferon alpha-2b product AP-003.  The IN2COVID trial is projected to start in the second quarter of this year and be completed by the end of the 3Q, the company said in a statement Thursday.  Interferon alpha-2b (IFN-a2b), a Type I interferon, is a naturally occurring protein integral to the body’s first line of anti-viral defenses. BetterLife said there is evidence that coronaviruses, such as SARS-CoV-2, have mechanisms that suppress IFN-a2b production, allowing the virus to evade the innate immune system.   READ: BetterLife Pharma announces tie-up with Carleton University to study TD-0148A as treatment for depression The company also noted that multiple clinical analyses show a significant link between deficiency in Type 1 interferon and the development of severe COVID-19 disease. There is also accumulating evidence from preclinical studies that coronavirus replication is blocked by the addition of exogenous INF-a2b.  For example, an exploratory study in Wuhan, China in COVID-19 patients, showed that patients treated with inhaled IFN-a2b had a more rapid rate of viral clearance than patients in the comparator arm, who did not receive inhaled IFN-a2b. BetterLife said the goal of the IN2COVID trial is to confirm the benefit of inhaled IFN-a2b in early-stage COVID-19 patients.  The IN2COVID trial protocol 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 (<5 days of diagnosis of COVID-19). The IFN-a2b treatment arms will receive Altum’s AP-003, administered via nebulizer, twice daily for 10 days. "We are excited to be collaborating with the School of Medicine at Pontificia Universidad Católica de Chile to conduct this trial in COVID-19 patients,” said BetterLife CEO Dr Ahmad Doroudian. “The team, as well as the trial center, are the leaders in Chile in conducting COVID-19 trials.” BetterLife said the IN2COVID study will be conducted by a multidisciplinary team of investigators lead by Dr. Arturo Borzutzky, director of the Translational Allergy and Immunology Laboratory, Department of Infectious Diseases and Pediatric Immunology of the School of Medicine at Pontificia. Dr Borzutzky 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: the time it will take to vaccinate the whole population; not knowing the duration of protection afforded by the current vaccines; emergence of SARS-CoV-2 variants; and emergence of possible totally 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.” Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham