Algernon Pharmaceuticals Inc (CSE:AGN) (FRA:AGW) (OTCQB:AGNPF) announced Monday that it has now enrolled 154 patients in its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.
Due to attrition, which is a common occurrence in clinical trials, the company said it has decided to increase the total number of patients in the study to 168 to compensate. As a result, the company will be adding an additional 14 patients before it announces that enrollment in the study has closed.
“We are almost there in terms of completing patient enrollment,” said CEO Christopher Moreau in a statement. “Sometimes when a study has a group that does not receive the treatment drug, you see a higher percentage of patients dropping out, than is typically seen. By adding approximately 12% to the original target total of 150 patients, we should be able to ensure we achieve the proper study size to power our data calculations.”
Algernon noted that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 disease (or the SARS-2 coronavirus) at this time.
The company’s multinational Phase 2b/3 human trial for COVID-19 is 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."
The trial has begun 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 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.
Algernon said the 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 milligrams (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.
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 believes Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19-infected patients.
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