VANCOUVER: Algernon Pharmaceuticals Inc., a clinical stage pharmaceutical development company, has received ethics approval from a central institutional review board for U.S. study sites for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for COVID-19.

Ifenprodil is an NMDA receptor antagonist specifically targeting the NMDA-type subunit 2B. The Company has also signed agreements with two research sites in Australia and one in Romania. Ethics approval for the study has been submitted in Australia and will be submitted for Romania and the Philippines shortly.

The Company is advancing on its multinational Phase 2b/3 human trial for COVID-19 entitled, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the treatment of hospitalized patients with confirmed COVID-19 Disease.”

Company announced on March 06, 2020 that it was going to explore Ifenprodil as a possible treatment for COVID-19 when it discovered an independent research study that showed the drug was active in an animal model for H5N1, the world’s most lethal avian flu, with an approximately 60% mortality rate in humans. In the study, Ifenprodil reduced mortality by 40% and reduced acute lung injury and inflammation in the lung tissue.

Coupled with the Company’s own animal data showing Ifenprodil’s reduction of lung fibrosis in two separate studies, the Company is investigating Ifenprodil to determine if it can reduce the severity and duration of a COVID infection.

Based on additional feedback from the U.S. FDA, the Company is planning to increase the size of the Phase 2b part of the study from 100 to 150 patients by adding a second treatment arm where patients receive a higher dose of Ifenprodil.

The trial will begin as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 study. The Phase 2b data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.

Patients will be randomized in a 1:1:1 manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg tablet three-times daily), or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily).

The primary endpoint will be the change in a patient’s clinical score using the World Health Organization’s ordinal scale. In addition, over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.

The Company has received regulatory clearance from the U.S. FDA and Health Canada. In an effort to ensure the timely enrolment of the 150 COVID confirmed hospitalized patients in as short a time period as possible, the Company requested Novotech, its CRO partner, to identify two additional countries to add to the multinational study.

As a result, Novotech has been conducting a feasibility study in the Philippines and Romania, where they have established relationships with researchers and institutions, and where there are still a significant number of confirmed COVID cases.

There will be no pre-set number of patients assigned per site, and the goal is to reach the enrollment number of 150 patients as soon as possible across all sites and all countries.

Algernon is working with five study sites in the U.S. and has completed all site selection visits and is working to finalize all contract negotiations. The Company has also received approval from a central institutional review board that applies to all sites. The states where the institutions are located include Florida, Illinois, Missouri and Ohio.

The Company is also in discussions with a short list of sites in Canada, however, there has been a significant decline in confirmed hospitalized cases in the country.