The Vancouver-based company is preparing the same study protocol for submission to the FDA and Australian regulatory authorities
Algernon Pharmaceuticals Inc () (OTCQB:AGNPF) said it has submitted a Clinical Trial Application to Health Canada for a Phase 2b/3 multinational clinical trial using NP-120, known as Ifenprodil, as a coronavirus (COVID-19) therapy.
In a statement Wednesday, the company said the same study protocol is being prepared for submission to the US Food and Drug Administration and Australian regulatory authorities.
Algernon said the study will be an adaptive pilot to pivotal trial design based on guidance from the World Health Organization to determine if Ifenprodil can improve clinical symptoms and reduce the number of COVID-19 infected patients from progressing to mechanical ventilation with intubation and death.
READ: Algernon Pharmaceuticals to seek FDA approval for clinical trial to treat coronavirus patients with Ifenprodil
The trial will begin as a Phase 2b study and after an interim analysis is performed on the first 100 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial, the company said.
With positive preliminary data, the clinical trial would move directly from a Phase 2b into a Phase 3 without the time delay involved in having to submit a new Clinical Trial Application.
In the Phase 2b study, Algernon said patients will be randomized in a 1:1 fashion to receive either standard of care (SOC) or SOC and Ifenprodil (20 mg three times per day) for a two-week treatment period. An improvement in the ordinal clinical scale is the initial primary endpoint and a number of secondary endpoints including mortality, blood oxygen levels, time in the ICU and time to mechanical ventilation will be studied.
“We are very excited about having the potential opportunity to transition this Ifenprodil COVID-19 trial into a Phase 3 study based on positive preliminary data,” said Algernon CEO Christopher Moreau.
“Pending approval, we would be included with only a small handful of companies globally working with a potential drug treatment at a Phase 3 level on this disease.”
Algernon cautioned, however, that it is in the early stages of clinical research and development and 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.
NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). The drug prevents glutamate signaling. The NMDA receptor is found on many tissues including lung cells and T-cells as well as neutrophils.
The Vancouver-based company believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 patients.
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