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Algernon Pharmaceuticals Inc. (symbol: AGNPF) is a Canadian clinical stage pharmaceutical development company dedicated to advancing treatments for unmet global medical needs. The company operates multiple research programs targeting chronic kidney disease, chronic cough, and non-alcoholic steatohepatitis (NASH). Algernon is also the parent company of Algernon NeuroScience, a subsidiary focused on the investigation of a proprietary form of psychedelic DMT for stroke and traumatic brain injury.
Recently, Algernon has achieved significant milestones, such as receiving a notice of intention to grant a patent from the Chinese Patent Office for its antifibrotic drug candidate NP-251 (Repirinast). This patent, which will be valid through 2038, enhances the global protection of the company's intellectual property. Another notable development includes the sale of its NP-120 (Ifenprodil) research program to Seyltx Inc. for USD $2 million and a 20% equity stake in Seyltx. Ifenprodil targets chronic cough by inhibiting NMDA receptors, and Seyltx is set to advance it through a Phase 2b clinical trial.
Algernon is also making strides with its DMT stroke research program under Algernon NeuroScience. The company plans to proceed with a Phase 2a study investigating the neuroplasticity effects of DMT in stroke patients. This program represents a pioneering effort to explore the potential of psychedelics in promoting brain recovery post-stroke.
Financially, Algernon has secured multiple patents in various markets, including Japan, Canada, Europe, and the United States, for its lead candidates. The company's forward-looking strategy involves robust intellectual property protection, strategic partnerships, and focused clinical trials.
In addition to its clinical advancements, Algernon has engaged ICP Securities Inc. for automated market making services to enhance liquidity and market presence. The company actively communicates with investors and stakeholders, as evidenced by planned special CEO interviews and Q&A sessions.
Algernon Pharmaceuticals is committed to developing effective treatments through rigorous research and strategic collaborations, positioning itself as a leader in innovative pharmaceutical solutions.
Algernon Pharmaceuticals Inc. (CSE: AGN; OTCQB: AGNPF) has received Orphan Drug Designation (ODD) from the U.S. FDA for Ifenprodil, aimed at treating Idiopathic Pulmonary Fibrosis (IPF). This follows the successful completion of a Phase 2a trial, where Ifenprodil met its co-primary endpoint and demonstrated improvements in patient-reported outcomes. ODD status provides various benefits, including tax credits and potential market exclusivity. CEO Christopher J. Moreau emphasized the significance of this milestone in developing Ifenprodil for IPF, a condition with a grave prognosis.
Algernon Pharmaceuticals Inc. has initiated screening for a Phase 1 clinical study of AP-188 (DMT) in the Netherlands, focusing on its safety, tolerability, and pharmacokinetics when administered intravenously. Up to 60 healthy volunteers will participate, with the first dosing expected in December 2022. The study aims to establish a safe dose that avoids psychedelic effects and will also assess neuroplasticity-related biomarkers. Preclinical studies support DMT's potential for stroke recovery by promoting brain health.
Algernon Pharmaceuticals has announced a clinical trial agreement with Yale University to investigate multiple intravenous doses of DMT for depression treatment. The principal investigator, Professor Deepak Cyril D’Souza, aims to enhance understanding of DMT dosing effects. Algernon will supply cGMP DMT and jointly own the intellectual property developed during the study. Additionally, data from this trial may inform Algernon's stroke research program. The double-blind, placebo-controlled study will evaluate DMT in both healthy participants and those with depression.
Algernon Pharmaceuticals (CSE: AGN; OTCQB: AGNPF) announces that Dr. Rick Strassman will join CEO Christopher J. Moreau for a Science Keynote Address at the Wonderland conference on November 5, 2022. The address will focus on Algernon's Phase 1 clinical study of DMT for stroke treatment, supported by positive preclinical data. Algernon is the first to investigate DMT as a stroke treatment and has completed its intravenous formulation for the trial, with approvals in place. The company has also filed patents for DMT applications in ischemic stroke.
Algernon Pharmaceuticals Inc. announced a cash payment of approximately CDN $450K from a refundable tax credit program linked to its clinical research in Australia. This brings the total cash refunds received to over CDN $3.0M, enhancing the company's capital-efficient business model. The company also reported changes to its warrants, adjusting the exercise price to $3.75 due to a dilutive issuance from a recent private placement. These developments highlight Algernon's commitment to advancing its clinical programs while optimizing financial resources.
Algernon Pharmaceuticals has advanced its research on NP-120 (Ifenprodil) targeting idiopathic pulmonary fibrosis (IPF) with cough. The company has filed for Orphan Designation with the U.S. FDA, which provides incentives for rare diseases affecting fewer than 200,000 patients. In a Phase 2a study, Ifenprodil showed no worsening lung function and significant improvements in cough frequency and patient-reported quality of life. Algernon aims to expedite Ifenprodil's development as a potential new therapy, addressing the urgent need as IPF has a high mortality rate.
Algernon Pharmaceuticals has received approval for a Phase 1 clinical study of an intravenous formulation of DMT for stroke treatment in the Netherlands. The trial, set to start screening soon, aims to evaluate safety, tolerability, and pharmacokinetics of DMT while gathering data for future studies. Previous preclinical studies indicated that DMT may promote neurogenesis and reduce tissue damage post-stroke. The study will involve up to 60 healthy volunteers, and there is optimism regarding the safety of DMT based on earlier trials.
Algernon Pharmaceuticals announced its role as the Headline Sponsor for the Wonderland 2022 conference in Miami from November 3-5. CEO Christopher J. Moreau will present two keynotes on November 4 and 5. Algernon is advancing its clinical research on DMT for stroke treatment and aims to initiate a Phase 1 trial in Q4 2022. The company has completed its intravenous formulation, applied for ethics approval, and will study DMT's safety and efficacy in healthy volunteers.
Algernon Pharmaceuticals has announced positive results from its Phase 2a study of NP-120 (Ifenprodil) for treating idiopathic pulmonary fibrosis and chronic cough. The trial met its co-primary endpoint of lung function preservation, showing no worsening of forced vital capacity over 12 weeks.
Secondary endpoints indicated stable diffusion capacity and improved cough-related metrics. Ifenprodil was well tolerated, achieving over 90% compliance. Upcoming presentations include the 21st International Colloquium on Lung and Airway Fibrosis in October 2022. The company plans to seek FDA orphan designation and file for a Phase 2b trial.
On August 23, 2022, Algernon Pharmaceuticals announced that its largest shareholder, AlphaNorth Asset Management, acquired 150,000 shares through a private placement, raising its ownership to over 13%. Steve Palmer, CEO of AlphaNorth, highlighted that the recent share price weakness provided a good opportunity for investment and expressed strong support for Algernon's drug pipeline. CEO Christopher J. Moreau welcomed this endorsement, emphasizing the company's focus on advancing its clinical drug development operations.