Algernon Pharmaceuticals Inc (CSE:AGN) (FRA:AGW) (OTCQB:AGNPF) announced Monday that its 168th and final patient has been enrolled in its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.
In addition, the company recently announced that it would be providing interim data from 75 patients from day 15 of their participation in the study in the first week of December.
But since the treatment period after enrollment is two weeks, with a two-week follow-up thereafter, the interim data readout date has now been moved to the third week of December to ensure that the patients who recently enrolled can complete their treatment regimen before data is presented, Algernon said in a statement.
“I want to thank the entire AGN team, including all of our clinical trial investigators and their staff, for helping us reach the goal of 100% patient enrollment,” said CEO Christopher Moreau. “Our next big step is to see how the preliminary data is trending and we remain hopeful it will show that Ifenprodil is reducing both the severity and duration of a COVID-19 infection. Even with the recent success of certain vaccines in clinical trials, medical doctors need to have effective therapeutic treatment options as well.”
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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