Algernon Pharmaceuticals Files U.S. FDA Pre-IND Meeting Request for Ifenprodil Chronic Cough Phase 2 Study

Rhea-AI Summary

Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) has filed a pre-IND meeting request with the U.S. FDA for its NP-120 (Ifenprodil) aimed at treating refractory chronic cough. This potential first-in-class treatment shows promising trends from an interim analysis of its ongoing Phase 2 study in Australia and New Zealand. Results revealed a significant reduction in cough counts after 12 weeks. Depending on FDA feedback, the U.S. Phase 2 study could begin in Q2 2022. Chronic cough, affecting 10% of adults, currently has no approved therapies.

Positive

• Filed pre-IND meeting request with U.S. FDA for NP-120 (Ifenprodil).
• Promising interim results from Phase 2 study showing significant cough count reduction.
• Potential to commence U.S. Phase 2 study by Q2 2022.

Negative

• None.

VANCOUVER, British Columbia, Oct. 08, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that it has filed a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (U.S. FDA) for its investigation of NP-120 (Ifenprodil) for a planned Phase 2 study for the treatment of refractory chronic cough. Ifenprodil, is an NMDA GluN2B subunit inhibitor and may represent a potential novel “first-in-class” treatment for chronic cough.

The Company recently announced positive trending data from its Phase 2 study of idiopathic pulmonary fibrosis and chronic cough that is currently ongoing in Australia and New Zealand. The results from an interim analysis of the chronic cough part of the study showed a relative reduction versus baseline in the mean 24-hour cough count in subjects after 12-weeks of treatment. There was also a decrease in the mean waking cough count at week 12 versus baseline (descriptive statistics).

Depending on the feedback from the U.S. FDA, the Company could begin its Phase 2 chronic cough study as early as Q2 of 2022 in the U.S. The Company wishes to thank Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester, and a leading global scientific expert on chronic cough, for her assistance with the protocol synopsis for the planned Phase 2 study. Dr. Smith joined the Algernon Medical and Scientific Advisory Board on February 7th, 2021. 

“This submission to the U.S. FDA underscores our commitment to patients with refractory chronic cough,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “Many of these patients experience a significant negative impact on their quality of life, and there are currently no approved treatments.”

About Chronic Cough

Chronic cough (defined as a cough lasting more than 8 weeks) affects approximately 10% of the adult population globally and is one of the most common conditions for which medical care is sought. In a subset of cases, symptoms cannot be resolved by treatment of underlying conditions; this is known as refractory chronic cough (“RCC”). There is currently no approved treatment for RCC.

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 and certain types of cancer cells.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, 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.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com. 

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

 

FAQ

What is the purpose of Algernon Pharmaceuticals' NP-120 study?

The NP-120 study aims to investigate its potential as a treatment for refractory chronic cough.

What were the findings of the Phase 2 study regarding NP-120?

The Phase 2 study showed a significant reduction in cough counts after 12 weeks of treatment.

When could the U.S. Phase 2 study for NP-120 begin?

The U.S. Phase 2 study could begin as early as Q2 2022, pending FDA feedback.

How many adults are affected by chronic cough globally?

Chronic cough affects approximately 10% of the adult population worldwide.

Is there an approved treatment for refractory chronic cough?

Currently, there are no approved treatments for refractory chronic cough.