Algernon Pharmaceuticals Announces Topline Data From its Phase 2b/3 COVID-19 Trial of Ifenprodil

Rhea-AI Summary

Algernon Pharmaceuticals Inc. (CSE: AGN, OTCQB: AGNPF) announced topline data from its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil). Key findings revealed 0% mortality in the 20 mg Ifenprodil group at Day 15 versus 3.3% in the control group. Patients with low blood oxygen showed a return to normal levels more quickly in the treatment group. However, the WHO score showed no significant changes across study arms. The company plans to discuss results with the U.S. FDA and publish detailed data in a peer-reviewed journal.

Positive

• 0% mortality in the 20 mg Ifenprodil group at Day 15 vs. 3.3% in control group.
• 100% of patients with low oxygen returned to normal levels by Day 4 with Ifenprodil.
• Trend towards less time in ICU for patients on Ifenprodil.

Negative

• WHO score showed no significant changes across study arms.
• No significant changes observed in the 40 mg dose group.
• Further analysis and additional patient data required for Phase 3 trial confirmation.

VANCOUVER, British Columbia, March 31, 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 topline data from the Phase 2b part of its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil).

The purpose of the Phase 2b part of the study was to identify one or more approvable U.S. FDA endpoints that showed a strong enough signal to consider moving forward into a Phase 3 study.

Key topline findings include:

All Cause Mortality:

At Day 15 of the study (the last day of treatment) there was 0% mortality in the 20 mg dose Ifenprodil treatment arm compared to a 3.3% mortality rate in the untreated control arm, p=0.18. For a Phase 3 trial to be sufficiently powered to confirm this endpoint, it is projected that 1,900 patients would need to be enrolled to reach a statistically significant result.

Oxygenation (SpO₂):

Of patients with a low blood oxygen level (SpO₂ <94%), 100% of patients in the 20 mg dose treatment arm returned to normal levels of oxygen at day 4 compared to day 9 for patients in the untreated arm (adjusted hazard ratio 1.91, 95% CI 0.97-3.77, p=0.061). Power calculations project that 450 patients would be required to confirm a statistically significant result with this endpoint in a Phase 3 trial.

Time in ICU:

Topline results for this endpoint indicate that there was also a strong trend to less time spent in the ICU in the overall study by patients in the 20 mg dose arm, as compared to patients in the untreated arm (adjusted hazard ratio 10.45, CI 1.23-88.61, p=0.0315). However, the Company cautions that additional, confounding variables were detected, and these numbers need to be confirmed with additional analysis, as well as power calculations conducted to project the required size for a Phase 3 study.

WHO Score and Other Endpoints:

The WHO score, the primary default endpoint for the study, showed a similar mean in all patients in all study arms. No significant changes were seen in other secondary endpoints, namely the time to hospital discharge, rates and duration of mechanical ventilation, or the NEWS score.

The Company investigated a 20 mg and 40 mg dose of Ifenprodil. Based on the initial data review, no significant changes were observed in the 40 mg dose group.

The Company intends to discuss the results of the trial with the U.S. FDA once the final data set has been fully reviewed and intends to present the complete data set in a peer-reviewed journal at a later time.

“The Company has done a tremendous amount of work in a very short period of time to get to this stage to see if Ifenprodil could help in the world’s fight against COVID-19”, said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “We look forward to completing our data review and receiving feedback from the U.S. FDA.”

The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates well-tolerated, 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 were the key findings from Algernon Pharmaceuticals' Phase 2b COVID-19 trial for AGNPF?

The trial showed 0% mortality at Day 15 in the 20 mg Ifenprodil group and a quicker normalization of oxygen levels compared to the control group.

What does the mortality data indicate for AGNPF's Phase 2b COVID-19 trial?

The trial showed a 3.3% mortality rate in the control arm, but this was not statistically significant compared to the 20 mg Ifenprodil group.

How does the Phase 2b COVID-19 trial impact AGNPF's future studies?

The company needs to discuss results with the U.S. FDA and is planning to conduct a Phase 3 trial with projected enrollment of about 1,900 patients.

What are the next steps for Algernon after the Phase 2b trial results?

Algernon plans to complete data review and submit findings to the U.S. FDA, as well as publish detailed results in a peer-reviewed journal.