Algernon Pharmaceuticals Receives U.S. FDA Orphan Drug Designation for Ifenprodil for the Treatment of Idiopathic Pulmonary Fibrosis

Rhea-AI Summary

Algernon Pharmaceuticals Inc. (CSE: AGN; OTCQB: AGNPF) has received Orphan Drug Designation (ODD) from the U.S. FDA for Ifenprodil, aimed at treating Idiopathic Pulmonary Fibrosis (IPF). This follows the successful completion of a Phase 2a trial, where Ifenprodil met its co-primary endpoint and demonstrated improvements in patient-reported outcomes. ODD status provides various benefits, including tax credits and potential market exclusivity. CEO Christopher J. Moreau emphasized the significance of this milestone in developing Ifenprodil for IPF, a condition with a grave prognosis.

Positive

• Orphan Drug Designation granted to Ifenprodil for IPF, enhancing development prospects.
• Phase 2a study showed Ifenprodil improved lung function stability and reduced cough frequency.
• Ifenprodil confirmed safe and well-tolerated during the clinical trial.
• ODD offers tax incentives and potential seven years of market exclusivity upon approval.

Negative

• None.

VANCOUVER, British Columbia, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that the United States Food and Drug Administration (“U.S. FDA”) has granted Orphan Drug Designation (ODD) to Ifenprodil as a treatment for Idiopathic Pulmonary Fibrosis (IPF). Ifenprodil is the sole active ingredient in NP-120, an NMDA receptor antagonist and the Company’s lead clinical candidate being developed for the treatment of IPF and chronic cough.

The Company recently concluded a Phase 2a study of Ifenprodil in patients with IPF. The trial met its co-primary IPF endpoint with patients receiving Ifenprodil experiencing no worsening of their lung function, and significant improvements were seen in the frequency of their IPF-associated cough as well. In addition, improvements in patient-reported measures of cough severity and quality of life were observed. Ifenprodil was also confirmed to be safe and well-tolerated in the study.

Supporting the development and evaluation of new treatments for rare diseases through ODD is a priority for the U.S FDA and other jurisdictions including Europe, that have similar orphan programs. 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. ODD qualifies sponsors for incentives including tax credits for qualified clinical trials and an exemption from user fees. If a product receiving ODD is subsequently granted approval, it receives seven years of market exclusivity, meaning that the U.S FDA may not approve any other applications, including a full New Drug Application, for the same product in the same indication.

“We appreciate the U.S. FDA’s decision to grant ODD status to Ifenprodil for IPF, a disease for which prognosis remains dismal, with 50% mortality expected within 3-4 years,” said Christopher J. Moreau, CEO of Algernon. “This regulatory milestone comes at an important time in the development of Ifenprodil as a potential new therapy for IPF, as we plan the next steps for our clinical program.”

About IPF

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 additionally affected by a dry non-productive cough, which can often get worse on exertion.

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 for unmet global 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 is the significance of the Orphan Drug Designation for AGNPF?

The Orphan Drug Designation for Ifenprodil allows AGNPF to access incentives such as tax credits and market exclusivity, which can enhance its development profile.

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

The Phase 2a study met its co-primary endpoint, showing no worsening in lung function and significant reductions in IPF-associated cough.

How does Ifenprodil work in treating IPF?

Ifenprodil is an NMDA receptor antagonist that specifically targets the NMDA-type subunit 2B, potentially modulating glutamate signaling in the lungs.

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a progressive lung disease characterized by severe scarring and irreversible decline in lung function, with no current cure.