Algernon gets FDA nod for human study of Ifenprodil for COVID-19
Algernon has received the FDA’s approval for the commencement of a Phase 2 and 3 human study of it’s repurposed drug Ifenprodil, for the treatment of COVID-19.
Algernon Pharmaceuticals, a Canadian clinical stage pharmaceutical development company, has confirmed that it obtained approval from the U.S. FDA, on the 3th of June 2020 for the recently filed experimental New Drug (IND) application for a scheduled multi-national Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil) as a prospective treatment option for COVID-19 patients.
Repurposing Ifenprodil for COVID-19
The clinical research for Ifenprodil is deemed, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients.”
As part of a multinational Phase 2b/3 COVID-19 clinical study, Algernon has already received approval in Canada and has also filed an ethical clearance in Australia.
Christopher J. Moreau, CEO of Algernon Pharmaceuticals said:
“We very much appreciated the timely responses that we have received from the U.S. FDA since we first began working with the agency on our COVID-19 clinical trial program. We have already begun the background work to start the Phase 2 trial in the U.S. and other countries as soon as possible and we will update the market shortly on our planned timelines.”
Algernon has warned that whilst it is planning to commence Stage 2 clinical trials relatively soon, the company is not making any statements that Ifenprodil is an efficient treatment for acute lung injury (ALI), the COVID-19 infection, or any other medical condition at present.
Phase 2b/3 Human Study for COVID-19
Once local ethical permits have been obtained, the experiment will proceed as a Phase 2b test with a minimum of 100 participants and with successful preliminary results, the clinical trial will progress forward from Phase 2b to a Phase 3 trial. The report would evaluate the proportion of patients expected to have an effect in the Phase 3 study. Patients will be randomly assigned on a one-to-one basis and will either be treated using an established standard of care or a standard of care plus a 20 mg dose of Ifenprodil taken three times a day for two weeks.
During the test period, physicians will see whether there is progress in a variety of secondary datasets, including mortality, blood oxygen levels, time spent in intensive care and time spent in mechanical ventilation.
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is an N-methyl – D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found in many tissues, including lung cells, T-cells and neutrophils. Algernon accepts that NP-120 can diminish the penetration of neutrophils and T-cells into the lungs where they can trigger glutamate and cytokine release. This may result in cytokine outbreak known as profoundly difficult to be controlled and may escalate to respiratory distress syndrome, compromised lung capacity and eventually to end up as a fatal complication in COVID-19 infected patients.
About Algernon Pharmaceuticals Inc.
Headquartered in Vancouver, Algernon Pharmaceuticals Inc. is focused on drug repurposing, research and implementation of secure, already licensed drugs for the treatment of new medical conditions. Algernon is switching them proficiently and securely into modern human trials, creating innovative definitions and looking for regulatory authorisations in the global pharma markets.
In particular, Algernon investigates compounds that have never been licenced in the U.S. or Europe to avoid non-label prescription composing.
Algernon has recorded new intellectual property rights worldwide for NP-120 (Ifenprodil) for the treatment of respiratory illnesses and is devoted to creating effective injectable and depot medicines.
For more information, please visit: algernonpharmaceuticals.com