BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRF) has engaged the clinical research organization (CRO) Pharmaceutical Solutions Ltd to manage its clinical trial of AP-003 as a treatment for mild-to-moderate coronavirus (COVID-19) cases at research sites across Australia.
The clinical trial, expected to launch later this year, will test AP-003, BetterLife’s inhaled recombinant human alpha 2b interferon drug, against a placebo. The trial, which the company claims is the first of its kind in Australia, is expected to recruit 150 patients.
Interferons are a natural part of the body’s innate immune system that are induced by viral infection, the company said, providing the body’s first line of defense. Interferon production is inhibited by the virus responsible for COVID-19, the company explained, but AP-003 is designed to bypass the COVID-19-induced interferon production blockade.
BetterLife believes that AP-003 could lessen the severity and duration of COVID-19 and decrease the need for hospital admissions.
“BetterLife’s treatment offers real promise to people who have a mild to moderate case of COVID-19,” Pharmaceutical Solutions managing director, Jacquie Palmer said in a statement. “It is exciting to bring this novel trial to Australia and to see the region help in the global fight against COVID-19.”
The randomized, double-blind, placebo-controlled trial will take place across several research sites in Australia, the company said.
“The Pacific region is an attractive clinical research environment which benefits from a world-class healthcare system that is not overburdened by COVID-19,” Palmer added. “The region has an engaged patient population and benefits from accelerated ethics and regulatory processes.”
BetterLife and Pharmaceutical Solutions will conduct the trial virtually to reduce the exposure of the investigative sites to COVID and allow the participants to remain at home, the company said. To make it work, the trial will rely on video consultations, questionnaires and mobile app technology.
‘’We are pleased to have Pharmaceutical Solutions as part of our team to support us in our clinical strategy for IFN-α2b as a therapeutic for COVID-19,” BetterLife CEO Ahmad Doroudian said. “We have assembled an exemplary team of scientific, clinical and regulatory experts, and now with Pharmaceutical Solutions as our Australian CRO we can quickly move forward with our trial.’’
The lead clinician in the study, Professor Stephen Hall, from Emeritus Research in Victoria, pointed to the prior success interferons have had in treating the virus.
“We are thrilled to have Betterlife’s AP-003 available to us to test in clinical trials in Australia to tackle mild to moderate presentations of COVID-19,” Hall said. “An exploratory trial from hard-hit Wuhan has demonstrated a significant reduction of the viral load using a interferon alpha-2b. Interferon-based therapies are now also undergoing clinical trials in Britain, Germany and the US.”