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Pharma & Biotech

Algernon Pharmaceuticals set for Phase 3 Ifenprodil coronavirus trial after go-ahead from DSMB

The external data and safety monitoring board (DSMB) has completed its latest review of the Phase 2b part of its Phase 2b/3 human study

Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF), the drug repurposing company, has reported a further step in its clinical trial process to assess Ifenprodil as a potential coronavirus (COVID-19) treatment.

The external data and safety monitoring board (DSMB) has completed its latest review of the Phase 2b part of its Phase 2b/3 human study and has given approval to continue on with Phase 3.

READ: Algernon Pharmaceuticals lead drug Ifenprodil named as potential COVID-19 treatment in European scientific journal

"While we await final data from the Phase 2b part of our Ifenprodil COVID-19 study, it is critical for us to know that from a safety perspective, we are now clear to move into the Phase 3 part of the study,” noted Christopher J. Moreau, CEO of Algernon Pharmaceuticals, in a statement.

Earlier this month, the pharma group said that the final set of data from the Phase 2b part of its Phase 2b/3 clinical trial would be available at the end of February.

If that data is positive, it will look to get emergency use authorization (EUA) from the US FDA, it said then.

A Phase 3 trial would be required regardless of whether or not it receives an EUA, the firm added.

Algernon reckons Ifenprodil may reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively.

The latter can result in the problematic so-called cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in coronavirus infected patients.

The DSMB is a committee of clinical research experts, including physicians and statisticians, who are monitoring Algernon's trial, and are reviewing safety and effectiveness data while it is ongoing.

Shares in Canada nudged up around 4% on the day to C$0.25 each.

----Updates for share price---

Contact the author at giles@proactiveinvestors.com

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