In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced it received ethics approval from a central institutional review board for U.S. study sites to conduct its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) as a treatment for COVID-19 at five in-country sites.
Based on feedback from the U.S. Food and Drug Administration feedback, the Vancouver, British Columbia-based biopharma added another arm to the trial design. This cohort will consist of 50 additional patients who will receive a higher Ifenprodil dose.
Now, patients will be randomized on a 1:1:1 basis to receive one of three treatment regimens. One is standard of care. Another is standard of care plus Ifenprodil 60 milligrams (60 mg), administered in a 20 mg tablet three times a day. The third is standard of care plus Ifenprodil 120 mg, given in two 20 mg tablets three times daily.
The primary endpoint will be the change in patients' clinical score using the World Health Organization's ordinal scale. Secondary endpoints will include improvement in mortality, blood oxygen levels, intensive care stay duration and time to mechanical ventilation.
Should initial data from Phase 2b be positive, the study will immediately move into Phase 3.
The U.S. and Canada are now on board for the trial, and Algernon is working to get approval from Australia, Romania and the Philippines as well to include, in the study, sites in their country.
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.