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FDA Greenlights Biopharma for Trial of Possible COVID-19 Therapeutic
News Update

Source:

Algernon Pharmaceuticals prepares to commence the Phase 2b study as soon as possible.

Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced in a news release the U.S. Food and Drug Administration approved a multinational Phase 2b/3 trial to evaluate the biopharma's ifenprodil as a possible COVID-19 treatment.

Now with U.S. and Canadian approvals to move forward, Algernon awaits the same from Australia.

"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," Algernon CEO Christopher J. Moreau said in the release. "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."

The trial, to commence as a Phase 2b, will involve 100 hospitalized patients with a confirmed COVID-19 infection. Participants will be randomized on a 1:1 basis to either be treated with the standard of care or the standard of care plus 20 milligrams of ifenprodil three times a day for two weeks. Ifenprodil is an NMDA receptor agonist.

Patients will be observed throughout the study for any improvements related to its endpoints, which include blood oxygen levels, duration in intensive care, time to mechanical ventilation and mortality.

If the preliminary data are positive, the trial will advance to Phase 3.

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Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Algernon Pharmaceuticals. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Algernon Pharmaceuticals. Please click here for more information.
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