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Biotech Cleared for Phase 2b/3 Trial of NMDA Receptor Antagonist for COVID-19 Patients in Canada
News Update

Source:

Algernon Pharmaceuticals reported it received approval from Health Canada for a Phase 2b/3 multinational clinical study of Ifenprodil in COVID-19 patients to prevent progression to intubation and mechanical ventilation.

In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that it has received a "No Objection Letter from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial." The firm advised that it is preparing the same study protocol in parallel for submission to both the U.S. Food and Drug Administration and regulatory authorities in Australia.

The company's Chief Science Officer Dr. Mark Williams commented, "The study is an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization (WHO) to determine if Ifenprodil can improve clinical symptoms of COVID-19 by reducing the number of COVID-19 diagnosed patients from progressing to mechanical ventilation with intubation and death."

Algernon Pharmaceuticals' CEO Christopher J. Moreau remarked, "We are very excited to have received clearance for our Phase 2b/3 study...We will begin to work immediately to get all aspects of the trial organized so that we can start as soon as possible including filing an IND for this same study with the U.S. FDA."

The firm stated that the trial will start off as a Phase 2b study of 100 patients and that after an interim analysis is completed on this first group of patients, the resulting data will determine the projected number patients required for Phase 3 to achieve statistical significance.

The company indicated that patients in the NP-120 (Ifenprodil) study will be randomized to receive either standard of care (SOC) or SOC and Ifenprodil 20 mg over a two-week period. The firm advised that the primary endpoint is to demonstrate an improvement in the WHO ordinal clinical scale. Additional secondary endpoints will be measured including mortality, blood oxygen levels, time in the ICU and time to mechanical ventilation.

The company said it is preparing to kick off the Phase 2 clinical trial soon in Canada and South Korea, but cautioned that "it is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for acute lung injury, the COVID-19 virus, or any other medical condition at this time."

The firm explained that "NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) and that Ifenprodil prevents glutamate signaling." The company stated that "it believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively and 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."

Algernon Pharmaceuticals is a drug re-purposing firm based in Vancouver, which investigates safe, already approved drugs for new disease applications.

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his 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.
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.
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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.




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