Algernon Pharmaceuticals Projects Full Enrollment for Phase 2 IPF and Chronic Cough Trial

Rhea-AI Summary

Algernon Pharmaceuticals has expanded its clinical trial for NP-120 (Ifenprodil) in idiopathic pulmonary fibrosis (IPF) and chronic cough by adding a site in Perth, Australia. With seven sites now participating, the company aims for full enrollment by December 2021 and anticipates a data readout in Q2 2022. Positive interim data from the trial shows a trend of reduced cough counts after Ifenprodil treatment. The trial's objective is to evaluate Ifenprodil's efficacy in preserving lung function in IPF patients and assessing its anti-inflammatory effects.

Positive

• Added a new clinical trial site in Perth, Australia, increasing total sites to seven.
• Aims for full enrollment of the Phase 2 trial by December 2021.
• Interim data shows trending positive results on cough count reduction from Ifenprodil treatment.

Negative

• Dependence on positive interim data; further results are pending in Q2 2022.
• COVID-19 lockdowns previously affected trial enrollment, indicating potential future risks.

VANCOUVER, British Columbia, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPD) a clinical stage pharmaceutical development company is pleased to announce that it has added a clinical trial site in Australia for its ongoing Phase 2 NP-120 (Ifenprodil) idiopathic pulmonary fibrosis (“IPF’) and chronic cough study. Corresponding with the recent opening up of the country from its COVID-19 lockdown policies, the Company is now projecting full enrollment of the trial by the end of December 2021, with a data readout in calendar Q2, 2022.

The Company announced in September 2021, that it had received positive trending interim data from the chronic cough part of its 20-patient Phase 2 IPF and chronic cough study. The interim analysis examined 24-hour total and waking cough counts measured using an ambulatory cough monitor at baseline and after 4 and 12 weeks of treatment with 20 mg of Ifenprodil, three times daily.

The data showed a trend to a relative reduction in cough count when compared to each patient’s baseline measurement control. In October 2021, the Company submitted a request to the U.S. Food and Drug Administration for a pre-IND (Investigational New Drug) meeting on the investigation of Ifenprodil for a planned Phase 2 trial for treatment of refractory chronic cough.

Phase 2 IPF & Chronic Cough Study Summary

The purpose of this proof-of-concept Phase 2 human trial is to determine the efficacy of Ifenprodil in the preservation of lung function in IPF patients (including biomarkers of fibrosis) and its associated cough. There are 7 sites in total now participating in the study with 5 located in Australia and 2 in New Zealand with the new additional site just added, located in Perth.

Ifenprodil has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a mouse model of IPF. In addition, Ifenprodil significantly reduced both cough frequency and onset in a guinea pig acute cough model.

“We are very pleased to be able to provide this update to the market on our IPF and chronic cough study,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “The lockdowns as a result of COVID-19 have had a very serious negative effect on clinical trial enrollment globally, and with this relaxation of policies in Australia we look forward to moving the trial towards its successful completion.”

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  

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 objective of Algernon Pharmaceuticals' Phase 2 trial for Ifenprodil?

The objective is to determine Ifenprodil's efficacy in preserving lung function in IPF patients and its associated cough.

What are the key timelines for the Ifenprodil trial?

The company expects full enrollment by December 2021 and a data readout in Q2 2022.

How many trial sites are currently involved in the Ifenprodil study?

There are currently seven trial sites involved, with five located in Australia and two in New Zealand.

What were the findings of the interim analysis for Ifenprodil?

The interim analysis indicated a trend towards reduced cough counts after treatment with Ifenprodil.

What is Ifenprodil being evaluated for in the trial?

Ifenprodil is being evaluated for its potential to treat idiopathic pulmonary fibrosis and chronic cough.