The Data and Safety Monitoring Board (DSMB) has recommended Algernon Pharmaceuticals to continue its Phase IIb/III clinical trial of Ifenprodil (NP-120) to treat Covid-19 patients.
This recommendation is said to indicate the lack of significant safety concerns in the study groups receiving treatment with the drug candidate.
Ifenprodil is an antagonist of the N-methyl-D-aspartate (NMDA) receptor. It is designed to selectively target the NMDA-type subunit 2B (Glu2NB) and prevent glutamate signalling.
The NMDA receptor is present on several tissues, such as lung cells, T-cells and neutrophils.
The drug candidate is expected to mitigate the infiltration of neutrophils and T-cells into the lungs where they may produce glutamate and cytokines, respectively.
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By GlobalDataCytokines can lead to cytokine storm, which causes the loss of lung function and ultimately death, as reported in Covid-19 patients.
Algernon Pharmaceuticals CEO Christopher Moreau said: “We are very pleased with the unanimous decision of the DSMB to carry on with the study. It confirms what we had previously identified regarding Ifenprodil’s long standing safety history.”
The multinational, randomised, open label Phase IIb/III trial is assessing the safety and efficacy of Ifenprodil as a potential treatment in hospitalised Covid-19 patients.
For the Phase IIb part, a total of 150 patients have been enrolled. Positive preliminary data will advance the study into a Phase III trial.
The Phase IIb results will help decide the number of participants required to achieve statistical significance in the Phase III part.
Participants are given an existing standard of care, or standard of care plus a Ifenprodil 20mg tablet three-times daily, or standard of care plus two Ifenprodil 20mg tablets three-times daily for two weeks.
Investigators will track any improvement in various secondary endpoints, including mortality, blood oxygen levels, duration in intensive care, and time to mechanical ventilation.
