Algernon Pharmaceuticals Files for Orphan Designation with the U.S. FDA for Ifenprodil as a Treatment of IPF

Rhea-AI Summary

Algernon Pharmaceuticals has advanced its research on NP-120 (Ifenprodil) targeting idiopathic pulmonary fibrosis (IPF) with cough. The company has filed for Orphan Designation with the U.S. FDA, which provides incentives for rare diseases affecting fewer than 200,000 patients. In a Phase 2a study, Ifenprodil showed no worsening lung function and significant improvements in cough frequency and patient-reported quality of life. Algernon aims to expedite Ifenprodil's development as a potential new therapy, addressing the urgent need as IPF has a high mortality rate.

Positive

• Ifenprodil demonstrated no worsening of lung function in Phase 2a trials.
• Significant improvements in cough frequency and quality of life were reported.
• Filing for Orphan Designation could provide tax credits and market exclusivity.

Negative

• The mortality rate for IPF patients remains high, indicating a severe unmet need.
• Dependency on successful regulatory approval for market access.

VANCOUVER, British Columbia, Sept. 19, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that it has decided to advance its investigation of NP-120 (Ifenprodil) for IPF with cough as its key indication. As a result, the Company further announces it has filed a request for Orphan Designation with the United States Food and Drug Administration (“U.S. FDA”) for the use of Ifenprodil as a treatment for IPF.

Supporting the development and evaluation of new treatments for rare diseases through orphan designation is a priority for the U.S. FDA and other jurisdictions (Europe) that have similar orphan programs. Orphan designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and a potential seven years of market exclusivity after approval. The designation is available only for rare diseases, defined by the U.S. FDA as those which affect fewer than 200,000 patients in the United States, which the Company’s research indicates that IPF may qualify.

IPF is a type of chronic lung condition characterized by a progressive and irreversible decline in lung function and scarring (fibrosis) of the lungs. There is no cure for IPF and there are currently no procedures or medications that can remove the scarring from the lungs. At least 70%-85% of patients with IPF are affected by a dry non-productive cough, which can often get worse on exertion.

The Company has decided to focus on the continued investigation of Ifenprodil for IPF with cough after hitting its key co-primary endpoint in its Phase 2a study of IPF with chronic cough. In the trial, patients receiving Ifenprodil experienced no worsening of their lung function, and significant improvements in the frequency of their IPF-associated cough. In addition, improvements in patient-reported measures of cough severity and quality of life were observed. The drug was also confirmed to be safe and well tolerated in the study.

“The outlook for patients with IPF remains dismal, with 50% mortality expected within 3-4 years, and so new treatments are desperately needed,” said Christopher J. Moreau CEO of Algernon. “Algernon will continue working to accelerate the development of Ifenprodil as a potential new therapy for IPF with cough.”

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. Ifenprodil represents a novel first in class treatment for both IPF and chronic cough.

About Algernon Pharmaceuticals Inc. 

Algernon is a Canadian clinical stage drug development company investigating multiple drugs with global unmet medical needs. Algernon has active research programs for IPF with chronic cough, chronic kidney disease, and a psychedelic program investigating a proprietary form of DMT for stroke.

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 recent development has Algernon Pharmaceuticals made regarding Ifenprodil?

Algernon Pharmaceuticals has advanced its investigation of Ifenprodil for idiopathic pulmonary fibrosis (IPF) with cough and filed for Orphan Designation with the U.S. FDA.

What is the significance of the Orphan Designation filed by Algernon Pharmaceuticals?

The Orphan Designation provides incentives like tax credits for clinical trials and potential market exclusivity, supporting the development of treatments for rare diseases.

What were the results of the Phase 2a study for Ifenprodil?

The Phase 2a study showed no worsening of lung function and significant improvements in cough frequency and quality of life among patients.

What is the expected mortality rate for patients with IPF?

The expected mortality rate for patients with IPF is 50% within 3-4 years, highlighting the urgent need for new treatments.

What is the stock symbol for Algernon Pharmaceuticals?

The stock symbol for Algernon Pharmaceuticals is AGNPF, traded on OTCQB.