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     285  0 Kommentare Algernon Announces 75% Enrollment in Multinational Phase 2b/3 Human Study of Ifenprodil for Treatment of COVID-19

    VANCOUVER, British Columbia, Oct. 02, 2020 (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 that it has now enrolled 75% of its enrollment target, which is 113 patients, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.

    The multinational human trial is being conducted in the U.S., Australia, the Philippines and Romania.

    The Company recently announced that the external Data and Safety Monitoring Board (DSMB) had unanimously approved the continuation of its 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, such as physicians and statisticians, and patient advocates who monitor the progress of a clinical trial and review safety and effectiveness data while the trial is ongoing.

    The Company has projected that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020.

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

    Phase 2b/3 Study Protocol Summary

    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."

    The trial has begun 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 will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (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, 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.

    About NP-120 (Ifenprodil)

    NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

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    Algernon Announces 75% Enrollment in Multinational Phase 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 VANCOUVER, British Columbia, Oct. 02, 2020 (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 that …