Clinical stage pharmaceutical development firm Algernon Pharmaceuticals is seeking ethics approval in Australia for its planned multinational Phase IIb/III study of its re-purposed drug Ifenprodil (NP-120) to treat coronavirus (Covid-19) patients.
Furthermore, the pharma group wants to conduct multinational Phase IIb/III clinical study for the drug in Canada and the US.
Ifenprodil is an N-methyl-D-aspartate (NDMA) glutamate receptor antagonist that specifically targets NMDA-type subunit 2B (Glu2NB).
The drug exhibits agonist activity for the Sigma-1 receptor, a chaperone protein up-regulated during endoplasmic reticulum stress.
Upon receiving all ethics approvals, the trial will begin as a Phase IIb study comprising 100 patients.
After receiving positive preliminary data, the study will move directly from Phase IIb to Phase III.
For the Phase IIb/III trial, patients will be randomised in a one-to-one manner.
Algernon noted that they will either be treated using an existing standard of care, or standard of care plus a 20mg dose of Ifenprodil taken thrice a day for a period of two weeks.
Algernon Pharmaceuticals CEO Christopher Moreau said: “Thanks to the hard work of our CRO partner Novotech, this ethics submission is yet another important step in the company’s Covid-19 clinical development programme.
“The Algernon team is working hard to finalise the US FDA IND application and will be updating the market on its progress shortly.”
The company also cautioned that it is not making any express or implied claims that Ifenprodil is an effective treatment for acute lung injury (ALI), the Covid-19 virus, or any other medical condition.
In March this year, Algernon retained Novotech, an Asia-Pacific clinical research organisation (CRO), for a planned Phase II clinical trial of Ifenprodil.