Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced in a news release it received approval from the South Korean government to launch a Phase 2 COVID-19 trial of the biopharma's repurposed drug, NP-120 (ifenprodil).
The study will evaluate this NMDA receptor antagonist in COVID-19-infected patients who have severe pneumonia. The 40 study patients will be randomized at a 1:1 ratio to receive either standard of care alone or standard of care plus ifenprodil. The trial will last four weeks.
The primary endpoint will be the rate of lung function improvement as measured by oxygen levels in the blood. Secondary endpoints will include rate of mechanical ventilation, effects on cough and breathlessness as reported by the patient, and mortality.
Trial enrollment is scheduled to start on May 8, 2020. The study's lead investigator will be Dr. Dong Sik Jung, an infectious disease professor at Dong-A University Hospital in Busan.
"This first human trial of Ifenprodil in COVID-19 patients is a major step forward with our new acute lung injury clinical research program," said Christopher J. Moreau, CEO of Algernon. "Positive Phase 2 data would be an important milestone as we continue to investigate Ifenprodil's therapeutic potential as a treatment for COVID-19, in addition to advancing our idiopathic pulmonary fibrosis and chronic cough program."
The company cautioned 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 (ALI), the COVID-19 virus, or any other medical condition at this time."
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