Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) announced Thursday it has received ethics approval from a central institutional review board for US study sites for its multinational phase 2b/3 human study of NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with the COVID-19 disease.
Based on additional feedback from the US Food and Drug Administration, the company said it is planning to increase the size of the Phase 2b part of the study from 100 to 150 patients by adding a second treatment arm where patients receive a higher dose of Ifenprodil.
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.
The trial will begin 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 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 1:1:1 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).
The primary endpoint will be the change in a patient's clinical score using the World Health Organization's ordinal scale. In addition, 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 has received regulatory clearance from the FDA and Health Canada. And in an effort to ensure the timely enrolment of the 150 COVID confirmed hospitalized patients in as short a time period as possible, the company requested Novotech, its CRO partner, to identify two additional countries to add to the multinational study.
As a result, Novotech has been conducting a feasibility study in the Philippines and Romania, where they have established relationships with researchers and institutions, and where there are still a significant number of confirmed COVID-19 cases.
Goal to enroll 150 patients
There will be no pre-set number of patients assigned per site, and the goal is to reach the enrollment number of 150 patients as soon as possible across all sites and all countries.
Algernon said it is working with five US study sites and has completed all site selection visits and is working to finalize all contract negotiations. It has also received approval from a central institutional review board that applies to all sites. The states where the institutions are located include Florida, Illinois, Missouri and Ohio.
The company has also signed agreements with two research sites in Australia and one in Romania. Ethics approval for the study has been submitted in Australia and will be submitted for Romania and the Philippines shortly. The company is also in discussions with a shortlist of sites in Canada.
Enrollment of the 1st patient for the Phase 2b/3 study is expected before the end of July 2020, Algernon said.
Meanwhile, the company said that one research site was initiated at the end of May 2020 in South Korea and two sites were initiated in early June for the investigator-led COVID Phase 2 trial. South Korea was chosen as an initial study location because it is one of two countries where Ifenprodil is currently approved to treat vertigo and dizziness.
The company has retained Cascade Chemistry, a US-based CRO specializing in chemical synthesis, to scale-up cGMP manufacturing of Ifenprodil.
As for its cash position, Algernon said it currently has about C$7.5million on hand to fund the studies.
"We continue to get closer to dosing our first patient in our Phase 2b/3 human trial investigating Ifenprodil for COVID," said CEO Christopher J. Moreau in a statement. "There is a tremendous amount of work involved and many moving parts to getting a multinational clinical trial underway once regulatory approvals are received and we will continue to update the market as we progress."
The company cautions that it is not making any express or implied claims that Ifenprodil is an effective human treatment for acute lung injury (ALI), COVID-19, or any other medical condition at this time.
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