The Canadian pharmaceutical company said Tuesday that data is pointing to a trend towards a reduction of patients needing mechanical ventilation in the high-dose Ifenprodil treatment arm by day 15 of the trial, as compared to patients in the untreated arm.
Algernon also said that it saw a trend in the high dose group to reduce the National Early Warning Score (NEWS) that determines the degree of illness more quickly than the control group after treatment was initiated, suggesting that the treated patients are recovering more quickly.
READ: Algernon Pharmaceuticals says the 168th and final patient enrolled in Phase 2b/3 human study of ifenprodil to treat COVID-19
While all patients had similar mean WHO and NEWS indicators by day 15, those that recover earlier may spend less days in the hospital. Many other COVID-19 therapeutics have received emergency use authorization from the US Food and Drug Administration (FDA) based solely on reducing the number of days in hospital, Algernon told investors.
The endpoint was not included in this interim analysis, but will be reported in the final data set, it added.
Ifenprodil was generally well-tolerated with no new serious safety concerns, the Vancouver-based company said. The majority of the adverse events were mild or moderate in severity.
Algernon told shareholders that it has increased its interim data set to 123 patients for some of the endpoints because of the availability of data. The company will add key endpoints to the first data set of Phase 2b stage, including time to discharge from hospital and length of time on mechanical ventilation.
Phase 2b’s objective is to determine the most appropriate endpoint target(s) for the Phase 3 stage, as well as how many patients would be required to achieve statistical significance. The final data set from Phase 2b should be available in the first quarter of 2021.
“While we are very pleased that the interim data has provided us with some positive trending information, we still need to evaluate the full definitive results and statistics to be presented with the final data set,” said Christopher Moreau, CEO of Algernon Pharmaceuticals in a statement. “We will be especially interested to see the numbers on the overall time spent on ventilation and rate to ventilation to be reported in the final data set.”
Algernon said it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 coronavirus) at this time.
Contact Angela at [email protected]
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