Algernon Pharmaceuticals Announces Database Lock in Phase 2 Study of IPF and Chronic Cough
Algernon Pharmaceuticals Inc. has announced the database lock for its Phase 2 proof-of-concept study of NP-120 (Ifenprodil) targeting idiopathic pulmonary fibrosis (IPF) and chronic cough. The trial, which began in 2020 and enrolled 20 patients, aims to assess Ifenprodil's safety and efficacy. Topline data is expected in July 2022, with primary endpoints focusing on lung function and cough reduction. The study includes subgroup analysis based on cough counts and serum biomarkers of fibrosis.
- Phase 2 study of Ifenprodil has reached database lock, marking progress in clinical development.
- Topline data release is projected for July 2022, providing potential insights on Ifenprodil's efficacy.
- Study design includes comprehensive analysis of both lung function and chronic cough metrics.
- Only 20 patients were enrolled in the study, which may limit the robustness of the findings.
- The upcoming data may not meet market expectations, depending on outcomes related to primary endpoints.
VANCOUVER, British Columbia, June 13, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that its Phase 2 proof-of-concept study of NP-120 (“Ifenprodil”) for idiopathic pulmonary fibrosis (“IPF”) and chronic cough has reached database lock. This means that all data from the trial is now finally reported, cleaned and "locked" in the database. As previously stated, the Company is projecting that topline data will be available in July, 2022.
The study began in 2020, and recruited patients in Australia and New Zealand with an established diagnosis of IPF and a persistent cough. Recruitment ended in February, 2022, when 20 patients had been enrolled.
Phase 2 Study Summary
The purpose of this proof-of-concept Phase 2 human trial is to determine the safety and efficacy of Ifenprodil in patients with IPF and its associated cough.
In this open label, single-arm study, 20 patients were enrolled that had a diagnosis of IPF and a self-described moderate or worse cough (a score of >40mm on a cough visual analogue scale). Patients were treated with Ifenprodil (20 mg TID) for 12 weeks.
The primary endpoint of the IPF portion of the study is the proportion of patients who achieve zero reduction in lung function at 12 weeks vs. baseline. Lung function was measured by forced vital capacity (“FVC”).
The primary endpoint of the chronic cough portion of the study is a
However, based on data seen in recent IPF and chronic cough trials from other companies, Algernon will also perform a pre-specified subgroup analysis on patients with higher baseline cough counts. In addition, the Company will also measure the proportion of patients with a less than
In addition to safety and tolerability, the effect on serum biomarkers of fibrosis will also be reported including proC3, C3M, proC5, C5M, proC6, C6M and reC1M.
About Ifenprodil
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
Algernon has filed intellectual property rights globally for Ifenprodil for the treatment of respiratory diseases.
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com
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FAQ
What is the purpose of Algernon Pharmaceuticals' Phase 2 study for Ifenprodil (AGNPF)?
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When will the topline data for the Ifenprodil study be available?
How many patients were involved in the Ifenprodil study conducted by Algernon Pharmaceuticals (AGNPF)?
What is the significance of the database lock for Algernon Pharmaceuticals' study?
