The company noted that despite the volume of coronavirus cases, including more than 8 million in the US, just 60,000 have been involved in any sort of therapeutic trial that is not vaccine-related, as estimated by the medical intelligence publication Evaluate.
BetterLife’s goal for trials of its drug AP-003 is to use technology to make life easier and simpler for patients. The company’s trials have been designed to promote study participation and streamline data collection by allowing patients with mild-to-moderate COVID-19 to self-identify for potential trial enrollment following COVID-19 testing.
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Trial consent will be obtained virtually and the trial will be conducted via telemedicine from the participant’s home, the company said. This allows the symptomatic participant to remain in their home but to have daily contact with medical personnel.
The use of telemedicine also decreases the risk of coronavirus exposure to study personnel. All data collection will be electronic, allowing for rapid review.
‘’Many shareholders have inquired as to our progress in this regard, and we are pleased to announce that we have made significant strides in advancing these trials in Australia,” CEO Ahmad Doroudian said in a statement. “Using new and innovative technology will allow us to be in the vanguard of clinical study design, to easily meet our enrolment goals, and to expedite any potential FDA approval and commercialization of AP-003 for the treatment of COVID-19.”
BetterLife’s clinical trial will test AP-003, an 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.
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