Here we go boys and girls...PHASE 2B/3 MULTINATIONAL CLINICAL TRIAL
Algernon applies for NP-120 clinical trial re COVID-19
2020-04-22 07:46 ET - News Release
Mr. Christopher Moreau reports
ALGERNON SUBMITS APPLICATION TO HEALTH CANADA FOR IFENPRODIL COVID-19 PHASE 2B/3 MULTINATIONAL CLINICAL TRIAL
Algernon Pharmaceuticals Inc. has submitted a clinical trial application (CTA) to Health Canada for an NP-120 (ifenprodil) COVID-19 phase 2b/3 multinational clinical trial. The same study protocol is being prepared for submission to the U.S. FDA and Australian regulatory authorities.
The study will be an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization (WHO) 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.
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. 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.
"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 Christopher J. Moreau CEO of Algernon. "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."
The Company cautions 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 (ALI), the COVID-19 virus, or any other medical condition at this time.
Phase 2b/3 Study Protocol Overview
The trial will begin as a Phase 2b study enrolling 100 patients with moderate/severe disease, which corresponds with a score of 4 or 5 on the WHO ordinal clinical scale. 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.
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils.
The 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 infected patients.
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