Study Shows 93% Cough Suppression With Co.'s Drug

Clinical-stage pharmaceutical development company Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA) announced the drug ifenprodil achieved a 93% reduction in median cough count in an acute guinea pig citric acid challenge study.

The study was designed to inform dose selection in a planned Phase 2b ifenprodil human study, recently named SILINDA, in refractory chronic cough (RCC), Algernon said. Patient enrollment in the study is expected to begin in early 2025.

The multi-dose study pre-clinical study was conducted under the direction of Seyltx, Inc., a private US-based drug development company that recently acquired Algernon's ifenprodil research program for the purchase price of US$2 million and a 20% equity position.

"The successful completion of this pre-clinical dose-ranging study, together with our human Phase 2a efficacy data, validates the target as a central node in this pathogenic process and informs our dosing regimen for our upcoming Phase 2b trial in RCC," said Seyltx Chief Executive Officer Dietrich A. Stephan, Ph.D. "We are now well positioned to execute our SILINDA Phase 2b program, and we look forward [to] enrolling our first patient in early 2025."

As the news was released Tuesday, Technical Analyst Clive Maund wrote that he believed the stock looked "ready to begin a major bull market."*

The analyst wrote that the stock lost "virtually all of its value" when it hit a low of CA$0.05 per share last November and has been recovering since then to CA$0.13 on Tuesday morning.

"With a small base pattern forming . . .  and the volume pattern increasingly bullish, a renewed advance up across the channel is to be expected soon," Maund wrote. "This is, therefore, thought to be a very good point to buy, and Algernon Pharma is rated a Strong Buy here for all time horizons."

The Catalyst: Ifenprodil 'Could Benefit Millions of Patients'

In the pre-clinical study, near-complete suppression of cough was observed in animals getting a dose of 30 mg/kg, in a dose-dependent manner, below the observed adverse effect level dose. Other dosing arms included 1, 3, and 10 mg/kg. Algernon said in a release that "a clear and statistically significant dose response was observed."

The company said the full results of the study will be presented at the London International Cough Symposium on July 18-19.

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NR2B subunit, which prevents glutamate signaling, Algernon said. The drug represents a first-in-class potential treatment for chronic cough and interferes with central signaling in the brain, suppressing the urge to cough.

"The dramatic cough suppression effects observed occur below the NOAEL dose and with no apparent impact on overall respiration," said Brendan Canning, Ph.D., professor of medicine at Johns Hopkins University School of Medicine and a member of the Seyltx Scientific Advisory Board. "These data give us confidence in ifenprodil's potential to be a best-in-class treatment option for RCC patients."

As the news was released Tuesday, Technical Analyst Clive Maund wrote that he believed the stock looked "ready to begin a major bull market."

Researchers plan to incorporate the recent findings related to optimal placebo run-in and clinical endpoints to "maximize SILINDA's probably of success," said Jacky Smith, professor of respiratory medicine at the University of Manchester and a member of the Seyltx Scientific Advisory Board.

"Given the effect sizes we are seeing, the potential to work across a broad patient population, and the uniqueness of the target, this product candidate could benefit millions of patients suffering with this untreatable disorder," Smith said.

Seyltx's SILINDA program is currently structured to include three dose arms and a placebo arm, evaluating the efficacy, safety, and tolerability of ifenprodil in about 240 adults with RCC, based on feedback from the U.S. FDA, the company said. SILINDA will be a placebo-controlled, parallel-arm trial randomized 1:1:1:1 with expected treatment arms of 40 mg TID, 80 mg TID, 120 mg TID, and placebo. The primary endpoint of 24-hour cough frequency will be measured at 12 weeks.

The program's primary endpoint will be assessed using the VitaloJAK cough-monitoring system in a patient population that is not stratified for baseline 24-hour cough frequency given the uniform efficacy seen in the Phase 2a open label study across both low- and high-cough count patients. Topline data from SILINDA are expected at the end of 2026.

Cough Treatment 'Big Business,' Analyst Says

Maund noted that the treatment of chronic cough is "big business."

"For example, GSK bought out Bellus for US$2 billion, which had developed the drug Camlipixant to combat chronic cough," wrote Maund. "Merck bought out Afferent for US$1.25 billion, which had developed the drug Gefapixant to combat chronic cough."

"A lot of time, effort, and money goes into developing effective new drugs and treatments," Maund continued, "which is why, when a company succeeds in developing them, big pharma manufacturers are keen to buy them and prepared to buy them up at a good price, as we have seen in the examples above."

Maund said if the drug, and another being studied by Algernon to treat stroke, is effective, it will be very likely that the company would receive substantial funding to further develop them or be bought out.

"Either way, the result can be expected to be highly beneficial for its shareholders," Maund wrote.

Ownership and Share Structure

According to the company, management and insiders own about 11% of the company, and about 21% is owned by institutions. The rest is with retail.

Top shareholders include Alpha North Asset Management with 20.52%, Chief Executive Officer Christopher Moreau with 5.05%, Chairman of the Board Harry Bloomfield with 1.97%, and Chief Financial Officer James Kinley with 1.4%, and Director Rajpaul Attariwala with 1.2%.

The company has 21.94 million shares outstanding with a market cap of CA$2.5 million. It trades in a 52-week range of CA$0.22 and CA$0.05.

Important Disclosures:

1. 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 Inc.
2. Steve Sobek wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
3.  This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
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* Disclosure for the quote from the Clive Maund source July 17, 2024

1. For the quote (sourced on July 17, 2024), the Company has paid Street Smart, an affiliate of Streetwise Reports, US$1,500. 
2. Author Certification and Compensation: [Clive Maund of clivemaund.com] is being compensated as an independent contractor by Street Smart, an affiliate of Streetwise Reports, for writing the article quoted. Maund received his UK Technical Analysts’ Diploma in 1989.  The recommendations and opinions expressed in the article accurately reflect the personal, independent, and objective views of the author regarding any and all of the designated securities discussed. No part of the compensation received by the author was, is, or will be directly or indirectly related to the specific recommendations or views expressed.

Clivemaund.com Disclosures

The quoted article represents the opinion and analysis of Mr. Maund, based on data available to him, at the time of writing. Mr. Maund's opinions are his own, and are not a recommendation or an offer to buy or sell securities. As trading and investing in any financial markets may involve serious risk of loss, Mr. Maund recommends that you consult with a qualified investment advisor, one licensed by appropriate regulatory agencies in your legal jurisdiction and do your own due diligence and research when making any kind of a transaction with financial ramifications. Although a qualified and experienced stock market analyst, Clive Maund is not a Registered Securities Advisor. Therefore Mr. Maund's opinions on the market and stocks cannot be  only be construed as a recommendation or solicitation to buy and sell securities.