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.
Read what other experts are saying about:
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.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Algernon Pharmaceuticals, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.