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AI Therapeutics has launched a Phase II clinical trial of LAM-002A (apilimod dimesylate) to treat newly diagnosed patients with Covid-19.
The company identifies new therapies using an artificial intelligence algorithm designed to match drugs to new indications.
Performed in alliance with Yale University, the randomised, double-blind, placebo-controlled Phase II trial will assess the safety, tolerability and efficacy of LAM-002A in a decreasing viral load.
The study will also investigate clinical efficacy measures, such as mortality, hospitalisation and oxygen saturation. Up to 142 outpatients will be part of the trial.
LAM-002A is a highly selective PIKfyve kinase inhibitor. In-vitro, the drug candidate showed potent antiviral activity against various isolates of SARS-CoV-2, the virus that causes Covid-19.
Findings from multiple studies revealed that LAM-002A hinders the entry and trafficking of the SARS-CoV-2 virus in cells.
The drug candidate’s mechanism of action is expected to allow its combination with other therapies, particularly with drugs targeting viral proteins or functions.
A recent independent study found LAM-002A to be the most effective out of 13,000 compounds assessed for inhibiting SARS-CoV-2, noted AI Therapeutics.
Yale University neurosurgery chair Dr Murat Gunel said: “LAM-002A’s safety has been demonstrated in more than 700 healthy subjects and patients with inflammatory and malignant conditions. It is one of the most potent drugs in pre-clinical tests against SARS-CoV-2.
“Its safety profile and effectiveness provide a strong rationale for urgently evaluating this drug in Covid-19 patients, who have few options to slow the progression of the disease.”
AI Therapeutics is also making preparations to enable access to LAM-002. The company already has 70,000 doses ready, another 70,000 in the making, and the compound in preparation for almost five million additional doses.
The drug candidate is intended to provide outpatient treatment option to prevent progression of the disease and hospitalisation for symptomatic Covid-19 patients.