Get the Latest Investment Ideas Delivered Straight to Your Inbox.

News Update

TICKERS: AGN; AGNPF; AGW

Pharma Developer Provides Interim Update from Phase 2b Ifenprodil COVID-19 Study
News Update

Share on Stocktwits

Source:

Algernon Pharmaceuticals provided additional interim data from its Phase 2b/3 Ifenprodil COVID-19 study outlining several potential primary endpoints for the Phase 3 portion of the trial.

In a news release, clinical stage pharmaceutical development company Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) presented some additional details clarifying the interim data reported for the Phase 2b portion of the firm's Phase 2b/3 clinical study of Ifenprodil for COVID-19.

Algernon Pharmaceuticals stated that it initially structured its Phase 2b/3 COVID-19 clinical trial protocol according to World Health Organization (WHO) guidelines under the WHO's master protocol version 2.0 dated Feb. 24, 2020. The company pointed out that these rules allow for a stated secondary endpoint to be changed to a primary endpoint going forward in the Phase 3 portion of a clinical trial.

Algeron noted that the goal of the Phase 2b part of its trial is to outline and investigate multiple endpoints and select those that display the highest efficacy. The firm said that this concept was anticipated and is incorporated into the clinical trial guidelines formulated by the WHO.

The company advised that after it had finalized its investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA), the FDA updated and changed its guidance pertaining to COVID-19 clinical trials. The firm mentioned that the FDA recommended "a preference for a respiratory failure-based endpoint as an alternative to the WHO score as the primary efficacy endpoint for the Phase 3 portion of the trial."

Algeron explained that clinical trials can be complex once undertaken and certain endpoints may validate efficacy while others may not. The company gave an example from its own Phase 2b study indicating that by day 15, there was a trend toward fewer patients requiring mechanical ventilation in the high dose Ifenprodil treatment arm versus patients grouped in the trial's untreated control arm even though all of the study's subjects had similar mean WHO and NEWS scores.

The company listed that by design its Phase 2b/3 trial encompasses many of the FDA's accepted COVID-19 trial endpoints. The firm listed that there six specific potential primary endpoints in its Phase 2b/3 trial including respiratory failure (which includes need for mechanical ventilation), need for intensive care, need for hospitalization, objective measure of sustained improvement such as oxygenation, ordinal measures of clinical improvement such as WHO and NEWS scores and lastly mortality.

The company advised that prior to the commencement of the study it has always been its intention to consult with the FDA on a possible path towards Emergency Use Authorization (EUA) after the completion of the Phase 2b final data set.

The firm's CEO Christopher J. Moreau commented, "The company believes that the interim data represents a very positive step in the investigation of Ifenprodil as a potential therapeutic treatment for COVID-19...We were very pleased to see positive trending data with a ventilation related endpoint that is favored by the FDA for COVID-19 trials. Further, Algernon has only provided interim data on three endpoints from day 15 of its 30-day Phase 2b/3 Ifenprodil COVID-19 study, with the majority of the data still to be reported."

Algernon described NP-120 (Ifenprodil) as "a N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) that prevents glutamate signaling," and explained that NMDA receptors are found on many types of tissues including lung cells, T-cells, and neutrophils. The company added that at this time it is not making any assertions or claims of any kind regarding the ability of Ifenprodil to contain, cure or eliminate SARS-CoV-2.

[NLINSERT]

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.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
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 decision to publish an article until three business days after the publication of the 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.





Recommendation for Streetwise Reports Readers

Be the First to Hear Direct from the Experts…Live and in Real Time!

StreetSmart Live! Was founded by the same team that that brought you Streetwise Reports.

Subscribe to the StreetSmart Live! YouTube channel and be the first to hear about interesting investment ideas live and in real time... straight from the experts. This type of intellectual capital is usually not made available to the general public, but StreetSmart Live! is your "In."

Subscribe Now (It's Free)

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe