New York, June 30, 2020 — BetterLife Pharma (BETRD) (BETR.CN) (NPAT.F), an emerging clinical stage pharmaceutical development company, believe that a coronavirus inhaler therapeutic may hold the key to helping patients fight off symptoms of coronavirus as soon as symptoms start. In a trial planned for later this summer, the company intends to begin a 150 patient Phase II study to test such a nebuliser (a device to turn the treatment into a fine mist), treating patients with pre-existing conditions early after COVID-19 infection.
BetterLife hope that their inhalation device – an experimental delivery system already used during the Wuhan crisis – along with its patent pending interferon alpha2b drug AP-003 will help patients by bolstering their own immune systems, to prevent them progressing to more severe stages of the disease and help avoid potential damage to their lungs, and then eventually heart, kidneys and the brain – the leading cause of death amongst COVID-19 patients.
Interferon beta is already used as an injection to boost the immune response of people with multiple sclerosis. But if the drug is inhaled via a handheld nebuliser, IFNa2b can be delivered directly to the lungs where it can help fight COVID-19 at the source.
In BetterLife’s planned trial, which is being designed with FDA guidance, patients will be treated within 5 days of being assessed and tested and before they develop dyspnea (when patients develop breathing problems and are rushed to hospital). The premise being put forward by the company is that an intervention with AP-003 within 7 days of exposure will inhibit the viral proliferation and allow the immune system to respond and prevent organ damage, thereby preserving life.
At the moment there is no approved treatment for COVID-19 and anyone who shows symptoms or tests positive for the virus is told to self-isolate until the symptoms become serious. The closest to a treatment and with relatively positive results is Gilead’s remdesivir.
This antiviral drug was been widely considered a front-runner in the rush to find viable treatments for a disease that has sickened more than ten million people worldwide and killed over 500,000, according to data aggregated by Johns Hopkins University. It is the first new drug to get emergency use authorization from the US FDA but hope for this being a viable therapeutic experienced a sharp correction on June 1 when the results of the remdesivir Phase III trial showed only modest improvement amongst patients receiving the experimental drug. The FDA in March authorized chloroquine and hydroxychloroquine to be repurposed for some COVID-19 patients though this has proven to be unsuccessful and at times lethal.
The company hopes that an inhaler delivering AP-003 directly to a patient’s lungs could make a difference by not only treating those who are seriously ill in hospital, but by eventually also being used as a coronavirus prophylaxis/prevention, allowing sufferers and those at high risk the ability to treat themselves at home before even becoming ill.
A number of recent studies have investigated the use of interferon alpha 2b (IFNa2b) on patients with cases of COVID-19 and found that the drug significantly accelerated clearance of the virus from the airways of patients. Dr. Eleanor Fish, a researcher with Toronto’s University Health Network and the senior author on one of the interferon studies commented that “awareness of interferon as a potential COVID-19 treatment has been slow to build and should be prioritized for larger-scale clinical trials.”
Dr. Fish is now on the Advisory Board of BetterLife Pharma and is advising on the upcoming trials.
AP-003 will contain BetterLife’s patent-pending and purer composition of IFNa2b, which our bodies produce when we get a viral infection.
In a recent release, BetterLife CEO Ahmad Doroudian said: “We are encouraged by the results of recent studies on the use of interferon for COVID-19 which further support the approach being taken by BetterLife.”
Disclosure: BetterLife Pharma is a client of BDA International.
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