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Algernon Pharmaceuticals wins FDA clearance to study Ifenprodil as potential therapeutic COVID-19 treatment

The Vancouver-based company has already received clearance in Canada and has filed for ethics approval in Australia for the multinational Phase 2b/3 clinical study

Algernon Pharmaceuticals Inc. - Algernon Pharmaceuticals In wins US Food and Drug Administration clearance for multinational study of Ifenprodi as potential therapeutic treatment for COVID-19
Ifenprodil may reduce the infiltration of neutrophils and T-cells into the lungs

Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) has received US Food and Drug Administration clearance for its planned multinational study of lead drug NP-120, known as Ifenprodil, as a potential therapeutic treatment for patients with the COVID-19 disease.

As part of the multinational Phase 2b/3 clinical study of the repurposed drug, Algernon has already received clearance in Canada and has also filed for ethics approval in Australia.

Ifenprodil could reduce the infiltration of neutrophils and T-cells into the lungs, where they can release glutamate and cytokines. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function, and ultimately death, in COVID-19 patients.

READ: Algernon Pharmaceuticals closes special warrants offering that raised nearly C$7M

As an N-methyl-D-aspartate (NMDA) receptor antagonist that targets the NMDA-type subunit 2B (Glu2NB), Ifenprodil prevents glutamate signaling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils. 

“We very much appreciated the timely responses that we have received from the US FDA since we first began working with the agency on our COVID-19 clinical trial program,” said CEO Christopher Moreau in a statement Thursday.

“We have already begun the background work to start the Phase 2 trial in the US and other countries as soon as possible and we will update the market shortly on our planned timelines.”

However, the Vancouver-based company cautions that while it is preparing to begin Phase 2 clinical trials shortly, it is not making any express or implied claims that Ifenprodil is an effective treatment for acute lung injury, the COVID-19 disease, or any other medical condition at this time.

Phase 2b/3 will start with an aggregate of 100 patients and, assuming positive preliminary data, will move into Phase 3. The data will determine the number of patients necessary to reach statistical significance.

All patients enrolled in the trial will be randomized in a one-to-one manner and be treated with an existing standard of care. A randomly selected group will also be given a 20-milligram dose of Ifenprodil three times a day over a two-week period. Doctors will observe patient outcomes in a number of categories, such as mortality, blood oxygen levels, length of time in intensive care, and time to mechanical ventilation.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

Quick facts: Algernon Pharmaceuticals Inc.

Price: 0.295 CAD

CSE:AGN
Market: CSE
Market Cap: $32.47 m
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Algernon Pharmaceuticals provides update on Phase 2B/3 study as they enroll...

Algernon Pharmaceutical (CSE: AGN-OTCQB: AGNPF) CEO Christopher Moreau joined Steve Darling from Proactive Vancouver with news the company has now enrolled a third of their patients in the Phase 2B/3 study of their repurposed drug Ifenprodil. Moreau discusses hitting that mark and also...

on 2/9/20

2 min read