KUALA LUMPUR, April 24 -- Algernon Pharmaceuticals Inc (Algernon) has received approval from the Ministry of Food and Drug Safety in South Korea, as well as ethics approval, for an investigator-led, Phase 2 COVID-19 clinical study of its re-purposed drug NP-120 (Ifenprodil), an NMDA receptor antagonist.
The clinical stage pharmaceutical development company, in a statement said the Lead Principal Investigator was Dr Dong Sik Jung, Professor, in the Division of Infectious Disease of Dong-A University Hospital, Busan.
The 40-patient, four-week trial, is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia. Patients are randomised in a 1:1 fashion to receive either standard of care (SOC) or SOC with Ifenprodil.
The primary endpoint will be the rate at which their lung function improves by measuring oxygen levels in the blood (Pa02/Fi02). Secondary endpoints will include mortality, rate of mechanical ventilation and patient reported effects on cough and breathlessness (dyspnea).
Enrolment in the phase 2 clinical trial is expected to begin on May 8.
The Company cautions that while it is preparing to begin a Phase 2 clinical trial shortly in South Korea, it is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for acute lung injury, the COVID-19 virus or any other medical condition at this time.
More details at www.algernonpharmaceuticals.com.
-- BERNAMA
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