BC firm to start COVID-19 human trials in S.Korea

By Mata Press Service

 

As it becomes increasingly clear that even when the COVID-19 pandemic is over, it may not really be over, researchers at a Vancouver-based pharmaceutical development company are not waiting for answers. They are working to find it.

“The sobering truth about the COVID-19 virus is not if you will survive it. It is how healthy your lungs will be after you recover,” notes Christopher J. Moreau, CEO of Vancouver-based Algernon Pharmaceuticals Inc. His company has just been approved to conduct human trials in South Korea on its re-purposed drug, NP-120 (Ifenprodil) that shows promise to protect the lungs from the COVID-19 virus.

Algernon has also received a ‘No Objection Letter from Health Canada’ to proceed with a multinational clinical trial to determine if Ifenprodil can reduce the number of COVID-19 diagnosed patients from progressing to mechanical ventilation with intubation and death.

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.

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 Pulmonary Fibrosis (PF), a condition where lung tissue hardens, and the organ does not function properly.

“This first human trial in South Korea of Ifenprodil in COVID-19 patients is a major step forward with Algernon’s new acute lung injury clinical research program,” 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 per cent and reduced acute lung injury and inflammation in lung tissue. H5N1 has a mortality rate of greater than 50 per cent.

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

“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, a contract research organization, which has been instrumental in the success of over a thousand clinical trials for biotechnology companies.

This month, in South Korea, Algernon will begin its 40-patient, four-week trial, designed to test the re-purposed drug NP-120 (Ifenprodil) in COVID-19 infected patients with severe pneumonia.

The Lead Principal Investigator in South Korea is Dr. Dong Sik Jung, also a professor in the Division of Infectious Disease of Dong-A University Hospital, Busan. Enrollment of the first Korean patients in the Phase 2 clinical trial is expected to begin on May 8.

In Canada the stage is set for Algernon to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial. The same study protocol is being prepared for submission to the U.S. FDA and Australian regulatory authorities.

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