Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) (FRA:AGW) said Monday that it plans to conduct an interim data review of its multinational Phase 2b/3 human trial of its lead drug NP-120 (Ifenprodil) as a potential treatment for coronavirus (COVID-19) sufferers.
In a statement, the Vancouver clinical-stage pharma company said it will look at the primary endpoint of the World Health Organization (WHO) ordinal score and also secondary endpoints, including the number of days that patients were in the intensive care unit and the hospital, as well as the number of days patients were on mechanical ventilation, and oxygen.
The data, from 75 patients on day 15 of the study, will be presented in a descriptive statistics format and Algernon is projecting the data readout will be in the first week of December 2020.
Algernon said it decided to conduct an enhanced interim data readout because of the surge in serious cases as a result of the second wave of the pandemic, the number of safety issues with vaccine and antibody trials, and the firm’s belief that Ifenprodil has the potential to reduce the severity of a COVID-19 infection.
“With the quickly increasing global threat from COVID-19, we believe we have an obligation to find out now how our COVID-19 trial is trending,” said Algernon Pharmaceuticals CEO Christopher J. Moreau.
“If Ifenprodil has been performing well in the study, this early look at the data may allow us to accelerate our COVID-19 program accordingly,” he added.
Phase 2b/3 study protocol
The company’s multinational Phase 2b/3 trial has begun as a Phase 2b study with 150 patients. With positive data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.
Patients are being randomized in a one-to-one 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) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.
The company noted that 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.”
Algernon believes that Ifenprodil could reduce the infiltration of neutrophils and T-cells into the lungs, where they can release glutamate and cytokines. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function, and ultimately death, in COVID-19 patients.
Algernon is also steadily advancing its lead drug NP-120 (Ifenprodil) as a possible treatment for idiopathic pulmonary fibrosis, acute lung injury, and chronic cough.
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