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Grey Matters Health Inc., formerly Algernon Health Inc. and Algernon Pharmaceuticals Inc., reports healthcare developments tied to its shift toward Alzheimer’s disease diagnostics and dedicated brain PET imaging. News for AGNPF has centered on NovaScan Neuroimaging Clinics, U.S. brain PET scanning center plans, CareMiBrain™ scanner technology, beta-amyloid detection, and clinical uses across dementia and other neurologic conditions.
Company updates also cover capital-structure actions, including name changes and share consolidation, equipment financing, service partnerships, clinic leases, and shareholder or governance matters. The company has also described Algernon NeuroScience’s regulated botanical wellness program involving a proprietary form of DMT and its equity interest in Seyltx, which is advancing Ifenprodil for chronic cough.
Algernon Pharmaceuticals Inc. (CSE: AGN) announced the successful completion of the first cohort dosing in its Phase 1 clinical study of intravenous AP-188 (DMT) at the Centre for Human Drug Research in the Netherlands. The safety review committee approved advancing to the next cohort due to no reported safety issues. This study aims to evaluate the safety, tolerability, and pharmacokinetics of DMT, a psychedelic compound, over an unprecedented 6-hour infusion. Following this phase, the subsequent study will involve dosing 60 healthy volunteers. Algernon is developing a sub-psychedelic DMT application for acute stroke treatment.
Algernon Pharmaceuticals has announced the initiation of a Phase 1 clinical trial for its intravenous formulation of AP-188 (DMT) in the Netherlands, aimed at evaluating its safety and pharmacokinetics. The trial, conducted at the Centre for Human Drug Research, involves up to 60 healthy volunteers and explores the potential neuroregenerative effects of DMT, particularly its role in stroke recovery. The study will assess biochemical markers and neuroplasticity-related measures. Data from this trial is anticipated by Q3 2023, which will inform the subsequent Phase 2 studies targeting ischemic stroke patients.
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) has appointed Dr. Peter Dicpinigaitis as a medical consultant for its chronic cough research program. Dr. Dicpinigaitis, an authority on cough management and the founder of the Montefiore Cough Center, will advise on a planned Phase 2b study involving 180 patients for NP-120 (Ifenprodil). The global chronic cough market is anticipated to grow from USD $6.15 billion in 2021 to USD $11.38 billion by 2029, indicating significant potential for effective treatments in this area.
Algernon Pharmaceuticals has announced a 180-patient Phase 2b clinical study of Ifenprodil for chronic cough, set to begin in Q3 2023. This novel treatment targets NMDA receptor subunit 2B to suppress cough urges. The decision follows positive Phase 2a data showing significant reductions in cough counts. The trial will assess Ifenprodil's efficacy and safety, with results expected to inform future regulatory pathways. The global chronic cough market could grow from USD $6.15B in 2021 to USD $11.38B by 2029, indicating strong potential for Ifenprodil.
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) has launched a new wholly-owned subsidiary, Algernon NeuroScience, to focus on its psychedelic DMT stroke program, valued at USD $20M. An asset transfer and management agreement for the DMT assets has been completed, with plans to raise up to USD $10M through a Reg A+ offering, selling 37.5% of AGN Neuro's shares. AGN Neuro aims to commence a Phase 1 and 2a DMT stroke study in Q4 2023, with potential future IPO plans contingent on study outcomes. AGN Pharma will continue to update on its broader research strategies shortly.
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.