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Canada-based Algernon Pharmaceuticals has obtained ethics approval from a central institutional review board for study sites in the US to conduct its Phase IIb/III clinical trial of Ifenprodil (NP-120) to treat Covid-19.
Ifenprodil is an antagonist of the N-methyl-D-aspartate (NMDA) receptor and is designed to selectively act on the NMDA-type subunit 2B (Glu2NB) to prevent glutamate signalling.
The multinational, randomised, open-label trial will assess the safety and efficacy of the drug for treating hospitalised patients suffering from Covid-19.
Algernon secured US Food and Drug Administration (FDA) clearance for the trial earlier this month. Based on the regulator’s feedback, the Phase IIb part’s size will be potentially increased from 100 to 150 patients by adding a second treatment group.
Participants in the second arm will be administered with a higher dose of Ifenprodil.
The trial will be initially conducted as a Phase IIb study in a total of 150 patients. If positive preliminary results are obtained, the trial will advance into a Phase III study.
Data from the Phase IIb part will be used to decide the number of expected patients required to achieve statistical significance in the Phase III study.
Participants will receive existing standard of care, standard of care plus Ifenprodil 60mg, or standard of care plus a 120mg dose of the drug.
The primary endpoint of the study will be the change in a patient’s clinical score, while secondary endpoints include mortality, blood oxygen levels, duration in intensive care, and time to mechanical ventilation.
Algernon has already received clearance from Health Canada to perform the trial, and its partner Novotech is conducting a feasibility study in the Philippines and Romania.
The company is working with five sites in the US and also entered agreements with two sites in Australia and one in Romania.
Algernon Pharmaceuticals CEO Christopher Moreau said: “We continue to get closer to dosing our first patient in our Phase IIb/III human trial investigating Ifenprodil for Covid.
“There is a tremendous amount of work involved and many moving parts to getting a multinational clinical trial underway once regulatory approvals are received and we will continue to update the market as we progress.”
Enrolment of the first trial participant is expected before the end of next month.