Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) said Thursday that it has completed a clinical trial agreement with the Westchester Research Center in Miami, Florida for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with the coronavirus (COVID-19) disease.
The company said Dr Aimee Gonzalez is the principal investigator, and patient enrolment for the study would begin soon after Algernon had conducted a site initiation visit to the Westchester General Hospital, in Miami, in the week of July 20.
Ifenprodil could reduce the infiltration of neutrophils and T-cells into the lungs, where they can release glutamate and cytokines. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function, and ultimately death, in COVID-19 patients.
Algernon said it is in final contractual negotiations with four additional US clinical sites. The company has already received ethics approval from a central institutional review board for all of the US study sites.
The Vancouver-based clinical-stage pharmaceutical development company is also in the final stages of completing contractual negotiations and receiving ethics approval in Australia, Romania and the Philippines.
“Of the five US research institutions we have been working with, two are located in Florida where they have recently had a significant number of confirmed COVID-19 cases,” Algernon Pharmaceuticals CEO Christopher J Moreau said in a statement.
“We look forward to working with Dr Gonzalez and appreciate her work in helping to get the trial started at Westchester General as soon as possible,” he added.
Goal to enroll 150 patients
The trial will begin as a Phase 2b/3 study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 study. The Phase 2b data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.
Patients will be 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 milligrams (taken as one 20 mg tablet three times daily), 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.
Algernon is a drug repurposing company that investigates safe, already approved drugs for new disease applications.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive