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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 (CSE: AGN) has received positive feedback from the FDA regarding its plans to investigate AP-188 (DMT) as an adjunct to physical therapy for stroke rehabilitation. Following a Pre-IND request submitted on March 16, 2021, the FDA agreed with the proposed preclinical efficacy experiments and provided guidance for preclinical safety studies. The Phase 1 clinical trial is slated for Q4 2021 in the UK. Algernon also filed provisional patents for DMT formulations and combination therapies. The company aims to be the first to test DMT in human trials for stroke.
Algernon Pharmaceuticals announced significant results from its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil), highlighting a 267 ng/L reduction in interleukin 6 (IL-6) levels in the 20 mg treatment group compared to 7 ng/L in the standard care group (p = 0.0292). This reduction indicates potential therapeutic implications for idiopathic pulmonary fibrosis (IPF) and chronic cough, as the company continues its Phase 2 trial targeting these conditions. Algernon has achieved 50% of its enrollment target for the IPF study, further measuring biomarkers such as C-reactive protein.
Algernon Pharmaceuticals has reached 50% enrollment for its Phase 2 clinical trial of NP-120 (Ifenprodil) targeting idiopathic pulmonary fibrosis (IPF) and chronic cough. The trial aims to evaluate Ifenprodil's efficacy in preserving lung function and reducing cough frequency in IPF patients. In preclinical studies, Ifenprodil demonstrated a 56% reduction in fibrosis and a 42% decrease in cough frequency. The IPF market is projected to grow significantly, from $900 million in 2015 to $3.2 billion by 2025, indicating potential market opportunities for the company.
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) has filed an end of Phase 2 meeting request with the FDA following the completion of its Phase 2b clinical trial for NP-120 (Ifenprodil) in COVID-19. This meeting aims to discuss clinical trial design and assess the transition to Phase 3 with expedited responses expected due to the pandemic context. The company clarifies it does not claim Ifenprodil can treat or prevent COVID-19. Algernon focuses on repurposing existing drugs for new therapeutic applications.
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) announced plans to request an End-of-Phase 2 meeting with the FDA following the completion of its Phase 2b COVID-19 trial for NP-120 (Ifenprodil). The company aims to discuss trial data and seek guidance for a potential Phase 3 study. Initial data review has shown some negative dose effects at the 40mg level, with further analysis on key endpoints such as mortality and ICU time planned. Algernon aims to leverage the FDA's feedback to inform their next steps in the development process.
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) appointed Dr. Steven L. Wolf as a consultant for its clinical research program on AP-188 (DMT) for stroke treatment. Dr. Wolf is a renowned expert in Physical Therapy and Rehabilitation Medicine, with over 300 publications and significant contributions to improving stroke recovery methods. His expertise will guide the design of the Phase 2 clinical study assessing DMT's potential to aid neural recovery post-stroke, following promising results from animal studies. This collaboration may enhance Algernon's research capabilities.
Algernon Pharmaceuticals Inc. (CSE: AGN, OTCQB: AGNPF) announced topline data from its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil). Key findings revealed 0% mortality in the 20 mg Ifenprodil group at Day 15 versus 3.3% in the control group. Patients with low blood oxygen showed a return to normal levels more quickly in the treatment group. However, the WHO score showed no significant changes across study arms. The company plans to discuss results with the U.S. FDA and publish detailed data in a peer-reviewed journal.
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) announced its inclusion in the Horizons Psychedelic Stock Index ETF in the first quarterly rebalance. This ETF offers investors exposure to North American companies engaged in psychedelic-related activities. CEO Christopher J. Moreau highlighted that this recognition reflects Algernon's significant progress in its DMT stroke research program. The company is investigating the use of DMT as a treatment for stroke and has filed provisional patents related to its formulations and methods.
Algernon Pharmaceuticals has filed a pre-IND meeting request with the U.S. FDA for its investigational drug AP-188 (DMT) targeting stroke-related dysfunction. This marks the start of formal communications regarding its stroke clinical research program. The application seeks FDA guidance on using DMT alongside constraint-induced movement therapy (CIMT) to enhance recovery in stroke patients. Positive preclinical studies indicate DMT promotes neurogenesis and motor recovery. Algernon also awarded contracts for DMT manufacturing and preclinical studies, with a focus on advancing stroke treatment.
Algernon Pharmaceuticals expects to report topline results from the Phase 2b part of its Phase 2b/3 COVID-19 trial of Ifenprodil in the last week of March 2021. This multinational study aims to evaluate Ifenprodil's safety and efficacy in hospitalized COVID-19 patients. The independent statisticians will review the data before public release. CEO Christopher J. Moreau emphasizes an urgent need for effective COVID-19 therapies. The trial's positive outcomes could lead to a Phase 3 trial with a larger patient cohort, aiding in the fight against severe COVID-19.