The company plans to submit an investigational new drug application to conduct a phase 2 clinical trial with Ifenprodil as a therapy for patients with experience respiratory complications

Algernon also has appointed retired US Ambassador to Belgium Howard Gutman to its newly created business advisory board

Algernon Pharmaceuticals Inc ( ) (OTCQB:AGNPF) said Monday it has received positive feedback from the US Food and Drug Administration regarding the company's plans to conduct a phase 2 COVID-19 clinical trial using its repurposed drug NP-120, known as Ifenprodil.

Based on the feedback, the company said it plans to submit, as soon as possible, an investigational new drug (IND) application to the FDA to conduct a phase 2 clinical trial with Ifenprodil as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus.

"We are very pleased with the expedited response we received from the FDA on our pre-IND application," said CEO Christopher Moreau in a statement. "This is the first time Ifenprodil has been presented to the FDA in a formal process and their response was very encouraging."

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

The company believes Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can each release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.

In other company news, Algernon said it has appointed retired US Ambassador Howard Gutman, former ambassador to Belgium, to the company's newly created business advisory board.

"Ambassador (retired) Gutman is an accomplished diplomat spanning decades of experience in both private and public sectors, and is also a widely featured commentator, guest speaker and media guest," said Moreau. "He brings a wealth of knowledge and expertise to his advisory position, which will help prepare Algernon as we advance into the next stage of development."

Algernon, based in Vancouver, is a drug repurposing company that investigates safe, already approved drugs for new disease applications. The company has filed new intellectual property rights around the world for Ifenprodil for the treatment of respiratory diseases and is working to develop a proprietary injectible, slow-release formulation.

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