Algernon Pharmaceuticals has completed the submission of an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to assess the Ifenprodil in the phase 2b/3 clinical study to treat Covid-19 patients.
The IND has been submitted for a multinational phase 2b/3 study to assess re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with Covid-19.
Ifenprodil, an N-methyl-D-aspartate (NMDA) receptor antagonist, is designed to target the NMDA-type subunit 2B (Glu2NB). It helps to prevent glutamate signalling.
Algernon has already secured clearance in Canada for the multinational phase 2b/3 Covid-19 clinical study. It has also filed for ethics approval in Australia.
Upon receiving local ethics approvals, the trial will start as a phase 2b study with an aggregate of 100 patients. Based on positive preliminary data, the trial will be advanced from a phase 2b into a phase 3 trial.
The company will randomise patients in a one-to-one manner and will either treat using an existing standard of care or standard of care combined with a 20mg dose of Ifenprodil taken three times a day for two weeks.
Algernon Pharmaceuticals CEO Christopher Moreau said: “We have already started communicating with a number of U.S. based research institutions in advance, to make sure that we can move quickly with the U.S. part of the clinical trial, if approved.
“We have identified strong interest to participate in the study and we look forward to starting the trial as soon as possible.”
Recently, Octapharma USA has secured approval from the FDA for its IND application to begin a phase three clinical trial to assess the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in Covid-19 patients with severe disease progression.
Octagam 10% is an immune globulin intravenous (human) liquid preparation designated to treat chronic immune thrombocytopenic purpura (ITP) in adults.