A new drug developed by Foresee Pharmaceuticals Co (逸達生技) to treat acute respiratory distress syndrome in COVID-19 patients has received approval from an independent data monitoring committee (IDMC) in the US.
In a filing with the Taiwan Stock Exchange on Monday, Foresee said that it had received a positive recommendation from an IDMC phase 2 safety review meeting to continue its phase 2/3 clinical trial of FP-025, a drug being developed to treat asthma and severe COVID-19 cases who have acute respiratory distress syndrome.
An IDMC is a group of experts external to a study that reviews cumulative data and treatment efficacy data and monitors patient safety in an ongoing clinical trial.
There is no medication available at present to treat acute respiratory distress syndrome and lung fibrosis, and if successfully developed, FP-025 would be a first-in-class therapy for the syndrome, Foresee said.
The phase 2 trial is part of a randomized, double-blind, placebo-controlled, multi-center phase 2/3 study, the company said.
An interim analysis is planned at the end of the phase 2 trial, and based on the results of the analysis, the trial may proceed to phase 3 with potential modifications to the research protocol, it said.
Approximately 99 people are taking part in the trial in the US, and the efficacy results are expected in the fourth quarter of this year.
The company would also assess the possibility of conducting trials in Taiwan, India and some Central and South American countries, Foresee said.
About 3 to 17 percent of COVID-19 cases develop acute respiratory distress syndrome, the company said, citing US Centers for Disease Control data.
Among those who are hospitalized, that number increases to 20 to 42 percent and to 67 to 85 percent for those admitted to intensive care, it said.
Before the COVID-19 outbreak, acute respiratory distress syndrome affected approximately 200,000 people a year in the US, resulting in nearly 75,000 deaths annually, and it accounts for 10 percent of intensive care unit admissions globally, the company said.
Foresee’s FP-025 is described as a highly selective inhibitor of matrix metalloproteinase-12, which has been identified as a component in causing pulmonary injury and fibrotic conditions in the lungs of COVID-19 patients.
It is a promising treatment for inflammatory airway diseases, the company said.
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