leadf
logo-loader
viewAlgernon Pharmaceuticals Inc.

Algernon wins Data and Safety Monitoring Board approval to continue its Phase 2b/3 human study of Ifenprodil to treat COVID-19

The DSMB is a committee of clinical research experts, including physicians, statisticians, and patient advocates, who are monitoring the progress of the company’s clinical trial

Algernon Pharmaceuticals Inc. - Algernon Pharmaceuticals Inc wins Data and Safety Monitoring Board approval to continue its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19
The trial is currently underway as a Phase 2b study of an aggregate of 150 patients

Algernon Pharmaceuticals Inc (CSE:AGN), (OTCQB:AGNPF) (FRA:AGW) announced Friday that the Data and Safety Monitoring Board (DSMB) has once again unanimously approved the continuation of the company’s multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. 

The DSMB is a committee of clinical research experts, including physicians, statisticians, and patient advocates, who are monitoring the progress of the company’s clinical trial, and are reviewing safety and effectiveness data while the trial is ongoing. The board’s decision came after a second meeting and review. 

“Clinical studies are focussed on the issues of safety and efficacy,” said CEO Christopher Moreau in a statement. “We are very confident of Ifenprodil’s safety and we look forward to discovering its efficacy in this very important COVID-19 trial.”

READ: Algernon announces 25% enrollment for its Phase 2 idiopathic pulmonary fibrosis and chronic cough study of Ifenprodil

The company’s multinational Phase 2b/3 human trial for COVID-19 is entitled, "A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease."

Algernon said the trial is currently underway as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial. 

Patients are being randomized in a one-to-one manner and are either being treated using an existing standard of care or standard of care plus Ifenprodil 60 milligrams (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.

Over the testing period, the company said doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care, and time to mechanical ventilation.

The Vancouver-based company is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure, or contain COVID-19 (SARS-2 coronavirus) at this time.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

Quick facts: Algernon Pharmaceuticals Inc.

Price: 0.28 CAD

CSE:AGN
Market: CSE
Market Cap: $30.82 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Algernon Pharmaceuticals Inc. named herein, including the promotion by the Company of Algernon Pharmaceuticals Inc. in any Content on the Site,...

FOR OUR FULL DISCLAIMER CLICK HERE

Algernon Pharma hits milestone in Phase 2b/3 human study of Ifenprodil...

Algernon Pharmaceuticals (CSE:AGN-OTCQB: AGNPF) CEO Christopher Moreau joined Steve Darling from Proactive to bring news the company has now enrolled 154 patients in its multinational Phase 2b/3 human study of Ifenprodil) for the treatment of COVID-19. Moreau telling Proactive they have...

1 day, 15 hours ago

2 min read