Algernon Pharmaceuticals has obtained US Food and Drug Administration (FDA) clearance for a Phase IIb/III clinical trial of its NP-120 (Ifenprodil) as a potential treatment for Covid-19.
Ifenprodil is an antagonist of N-methyl-D-aspartate (NMDA) receptor. The drug is designed to selectively act on the NMDA-type subunit 2B (Glu2NB) and prevent glutamate signalling.
It is believed to be capable of mitigating the infiltration of neutrophils and T-cells into the lungs, where they can produce glutamate and cytokines, respectively. Cytokines can result in cytokine storm related to the loss of lung function and death reported in Covid-19 patients.
The multi-national, randomised, open-label Phase IIb/II trial will assess the safety and efficacy of the drug to treat hospitalised patients with confirmed Covid-19.
After obtaining local ethics approvals, the study will be started as a Phase IIb study in a total of 100 patients. If positive preliminary results are obtained, the study will advance directly from a Phase IIb into a Phase III trial.
The study results will help determine the number of patients required to demonstrate statistical significance in the Phase III trial.
Participants will be given an existing standard of care or standard of care plus a 20mg Ifenprodil dose three times a day for two weeks. Various measures will be monitored, including mortality, blood oxygen levels, time in intensive care, and time to mechanical ventilation.
Algernon Pharmaceuticals CEO Christopher Moreau said: “We very much appreciated the timely responses that we have received from the US FDA since we first began working with the agency on our Covid-19 clinical trial programme.
“We have already begun the background work to start the Phase II trial in the US and other countries as soon as possible and we will update the market shortly on our planned timelines.”
For the Phase IIb/II trial, the company has already secured clearance in Canada and also filed for ethics approval in Australia.