Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA), a Canadian pharmaceutical development company, reports that the full data set from its Phase 2a study evaluating NP-120 or Ifenprodil to potentially treat idiopathic pulmonary fibrosis (IPF) and chronic cough is just as positive as the previously published top-line data.
The full data set even included statistically significant improvements in measures of cough.
That data took into account additional measures of efficacy, including the impartial measurement of lung function and patient-reported outcomes of both IPF and cough. These were not reported in the initial top-line data.
Research Capital Analyst Andre Uddin gives Algernon a 12-month price target of CA$25.
“The story here is that all of the secondary endpoints, including the tests for how carbon monoxide is transferred in the lungs, assessment tools used to determine shortness of breath, the overall health of the individual — all of these other indicators — are showing that everything is moving in the right direction,” Algernon CEO Christopher J. Moreau told Streetwise Reports.
Chris Temple, editor and publisher of the National Investor newsletter, has been following Algernon and writing about the latest news.
"I have followed Algernon intermittently for quite some time; very intrigued by the story and thesis but — at least in this example — wary about catching a falling knife," Temple wrote. "But it appears that the knife has finally hit the floor recently, and news out this morning has helped Algernon take a big step toward fulfilling its mission."
Technical Analyst Clive Maund agrees and says the outlook for Algernon is good as the company just passed the 200-day moving average of CA$5.33 per share.
“Fortunately, we bought it at a great entry point … we cannot rule out a minor reaction here before a larger move up,” Maund wrote in a September 1, 2022 post on clivemaund.com.
Top-Line Data
In late July, Algernon published the top-line data from a 12-week Stage 2a proof of concept study using Ifenprodil to treat IPF and chronic cough. IPF causes scar tissue to grow inside your lungs and makes it difficult to breathe, and the prognosis is poor. The median survival ranges from 2.5 to 3 years.
Of the 20 IPF patients who enrolled, 13 or 65% had stable or improved FVC over the 12 weeks, whereas 40% of those treated with a placebo demonstrated similar or higher FVC over those 12 weeks.
“The full data set is excellent,” said Dr. Martin Kolb, a professor of respirology at McMaster University in Canada and a global expert on IPF. “This data enhances my belief that this drug merits investigation in a much larger trial.”
The full results of the trial will be presented at the 21st International Colloquium on Lung and Airway Fibrosis in Reykjavik, Iceland, in October. A similar presentation is slated for Reston, Va., in June 2023 at the ninth American Cough Conference.
Catalysts
Algernon conducted a private placement financing in mid-August at CA$3.75. Since then, the company has been on a roll.
On volume of nearly 49,000 shares on Sept. 1 and about 41,000 a day later, which is around eight to 10 times more than its typical volume. AGN shares closed at CA$6.90 on Sept. 2, an 84% increase from the price in the mid-August placement.
The next step for Algernon will be a Phase 2b study for Ifenprodil, which will take about a year and have as many as 130 to 175 participants. The company will seek guidance from the U.S. Food and Drug Administration by filing a pre-Investigational New Drug application, the means through which, among other things, Algernon gets feedback on its study design and approval to run the Phase 2b clinical study.
The market for IPF is about US$4 billion.
Algernon also expects to receive approval sometime in September for a Phase 1 study on DMT (N, N - Dimethyltryptamine) to determine if it provides better outcomes for ischemic stroke patients. An announcement is expected in the near future.
The U.S. Securities and Exchange Commission and the NASDAQ have conditionally approved Algernon for a NASDAQ listing, provided the company meets certain pre-specified financial conditions. The company also expects to receive approval sometime in September for a Phase 1 study using DMT to treat ischemic stroke patients — a market thought to be worth US$40 billion.
In the study, Algernon scientists and the research team will test an intravenous formulation of DMT and provide the drug to patients for various durations (Phase 1 studies determine whether a drug is safe for humans).
In preclinical studies, DMT has caused neurons to grow and make new connections — a process called neuroplasticity, which is necessary after the brain suffers an injury.
The study should begin about 60 days after getting the thumbs up. The worldwide market for stroke treatment is thought to be around US$40 billion.
Algernon’s unique approach to drug development, known as drug re-purposing, means it can move several drugs forward simultaneously because it's an efficient way to advance drugs into the clinic.
Another drug known as Respirinast, first developed to treat asthma in Japan by Mitsubishi, is being repurposed by Algernon to treat chronic kidney disease.
The company is synthesizing its own formulation of the drug, which will move quickly into a small Phase 1 study.
“We are planning and working towards having three Phase 2 trials running next year,” Moreau told Streetwise Reports.
And the U.S. Securities and Exchange Commission and the NASDAQ have conditionally approved Algernon for a NASDAQ listing, provided the company meets certain pre-specified financial conditions.
Algernon now has 2,357,885 million shares issued and remains tightly held. The company’s current G&A burn rate is about $100,000 a month.
Research Capital Analyst Andre Uddin gives Algernon a 12-month price target of CA$25.
Toronto-based hedge fund AlphaNorth Asset Management owns about 13% of Algernon.
Algernon trades in a 52-week range of CA$3 and CA$11.90.
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