Canada-Korea human trials planned for COVID-19 patients

A Vancouver-based pharmaceutical development company is awaiting final approval to conduct human trials in South Korea for its repurposed drug NP-120 (Ifenprodil) that is showing promise to improve the lung functions of COVID-19 infected patients.

Algernon Pharmaceuticals Inc. believes that Ifenprodil, a neurological drug approved for treatment of vertigo and dizziness in Japan and South Korea, could reduce both the severity and duration of a COVID-19 infection, potentially limiting the progression of patients to ventilation and intubation.

Algernon has also received positive feedback from the U.S. Food and Drug Administration (FDA) on conducting a phase 2 trial as well as for its plans to reformulate its repurposed drug Ifenprodil, into a new intravenous product, best suited for hospital and ICU use.

Research around the world suggests that once coronavirus patients are placed on a ventilator, they will probably need to stay on it for weeks. And the longer patients remain on a breathing machine, the more likely they are to die or sustain lasting lung damage.

A report from London’s Intensive Care National Audit & Research Centre found that 67% of reported COVID-19 patients from England, Wales, and Northern Ireland receiving “advanced respiratory support” died. A study in a smaller patient group in China found that only 14% survived after going on a ventilator.

Another study, published March 30 in the New England Journal of Medicine, saw a mortality rate of 50 percent in patients who spent an average of 10 days on a ventilator.

Critical-care doctors are also reporting that those who make it out of the ICU after a long stint on a ventilator are more at risk to develop Idiopathic Pulmonary Fibrosis (IPF), a condition where lung tissue hardens, and the organ does not function properly.

“Algernon’s investigations of Ifenprodil for IPF have been very encouraging,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals.

“As a result of our research and some additional independent studies, Algernon has decided to expand its Ifenprodil clinical program to include potential treatments for acute lung disease and COVID-19.

“At Algernon, we focus on finding new uses for well known, proven and safe medicines…our scientists search out connections between safe and proven drugs already in use to be repurposed for new diseases they could treat,” said Moreau.

Ifenprodil, is a generic neurological drug, originally developed in the 1970’s by global health giant, Sanofi, and approved for use in South Korea and Japan.

In a recent animal study for H5N1 - the world’s most lethal flu - Ifenprodil reduced mortality by 40% and reduced acute lung injury and inflammation in lung tissue. H5N1 has a mortality rate of greater than 50%.

“If Ifenprodil performs this way in an animal study for H5N1 with, we should see a similar result in humans that have COVOD-19,” said Moreau.

Algernon’s 40-patient trial in South Korea is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia. The company is working with contract research organization, Novotech, which has been instrumental in the success of over a thousand clinical trials for biotechnology companies.

“There is a sound basis for thinking that Ifenprodil may be effective in patients with severe pneumonia caused by COVID-19 as there have been some promising results in animal studies involving H5N1 influenza,” said John Moller, chief executive officer of Novotech.

In South Korea, the human trials testing protocol planned involves treating 20 patients with severe pneumonia caused by COVID-19 with Ifenprodil, as well as standard treatments for up to four weeks. The outcomes and safety profile for this group of patients will then be compared to 20 patients who received only the standard treatments.

“While this is a relatively small study, the hope is that signals of efficacy can quickly be evaluated,” said Moller.

There are a number of approaches that are currently being looked at to combat COVID-19 including vaccines, anti-viral agents, and drugs that treat the complications of COVID-19 such as pneumonia, acute respiratory distress syndrome (ARDS) and septic shock.

While the longer term “silver bullet” to COVID-19 is likely to be a vaccine, this is probably some way off.

“Until that time, a combination of new and known antiviral agents, as well as drugs that treat COVID-19 complications, will hopefully reduce the number of severe cases, reduce ICU admissions, reduce mortality, and free up capacity across the health system,” added Moller.

New research on older drugs have shown promising clinical efficacy in treating the novel coronavirus and some are already being included in treatment plans.

Some of the repurposed and repositioned drugs include a combination of two HIV drugs, lopinavir and ritonavir; the antimalaria drug chloroquine and favipiravir, which is used to treat influenza in Japan.

Another antiviral compound, Remdesivir is undergoing clinical trials in China, the United States, and the United Kingdom as a potential treatment for COVID-19.

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