Algernon Pharmaceuticals gets Health Canada approval to proceed with Phase 2b/3 trial of potential coronavirus treatment

Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) received Health Canada clearance to proceed with the next phase of a multinational study looking at Ifenprodil, which could be used in the treatment of COVID-19. The Vancouver-based company said it got the go-ahead from Health Canada to commend Phase 2b/3 of the clinical trial of Ifenprodil, or NP-120, which Algernon believes can reduce the infiltration of damaging cells into the lungs that contribute to a loss of lung function. The same study protocol is being prepared for submission to the US and Australian regulators. READ: Algeron Phrmaceuticals in the spotlight with lead drug Ifenprodil as promising coronavirus therapy “We are very excited to have received clearance for our Phase 2b/3 study,” said Christopher Moreau, Algernon’s CEO said in a statement. “We will begin to work immediately to get all aspects of the trial organized so that we can start as soon as possible including filing an IND for this same study with the US (Food and Drug Administration).” Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist that specifically targets the NMDA-type subunit 2B (Glu2NB) and prevents glutamate signaling. Algernon believes Ifenprodil can reduce the infiltration of neutrophils – a type of white blood cell -- and T-cells into the lungs, where they can release glutamate and cytokines respectively. Cytokines can result in the dangerous cytokine storm that contributes to a loss of lung function leading to death in COVID-19 infected patients.  Phase 2b details The trial will begin as a Phase 2b study of 100 patients with a moderate or severe form of the disease. Patients will be randomized in a one-to-one manner to receive and will either be treated using an existing standard of care, or standard of care plus a 20mg dose of Ifenprodil taken three times a day 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. Data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial, Algernon told shareholders. If preliminary data is positive, the clinical trial will move directly from a Phase 2b into a Phase 3. DEEP DIVE: Algernon Pharmaceuticals aiming to repurpose drugs, with coronavirus trial go-ahead providing good example The study is an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization to determine if Ifenprodil can improve clinical symptoms of COVID-19, according to Algernon’s chief science officer Dr. Mark Williams. Algernon is hoping that Ifenprodil will reduce the number of COVID-19 diagnosed patients from progressing to mechanical ventilation, which could result in intubation or death. Algernon cautioned investors that while it is preparing to begin a Phase 2 clinical trial shortly in South Korea and Canada, it is not making any claims that Ifenprodil is an effective treatment for acute lung injury, the COVID-19 virus, or any other medical condition at this time. The firm has filed intellectual property rights globally for Ifenprodil and is working to develop an injectable and slow release formulation of the drug. Contact Angela at angela@proactiveinvestors.com Follow her on Twitter @AHarmantas