Taipei, July 5 (ANC) A new drug developed by Taipei-based Foresee Pharmaceuticals Co. to treat acute respiratory distress syndrome (ARDS) in patients with COVID-19 has received independent committee approval Data Surveillance (IDMC) in the United States.
In a dossier filed with the Taiwan Stock Exchange, Foresee announced 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 in development to treat asthma and severe COVID-. 19 patients with ARDS.
An IDMC is a group of experts outside of a study that examines cumulative data and data on treatment effectiveness and monitors patient safety in an ongoing clinical trial.
There is currently no drug available to treat ARDS and pulmonary fibrosis, and if developed successfully, FP-025 will be a first-class therapy for ARDS, according to Foresee.
The phase 2 trial is part of a multicenter, randomized, double-blind, placebo-controlled 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 could move to phase 3 with potential changes to the research protocol, he said. declared.
About 99 patients are participating in the ongoing trial in the United States, and efficacy results are expected in the fourth quarter of 2021.
The company will also assess the possibility of conducting trials in Taiwan, India and some countries in Central and South America, Foresee said.
Currently, about 3 to 17 percent of COVID-19 patients develop ARDS, the company said, citing data from the U.S. Centers for Disease Control.
Among hospitalized patients, this number rises to 20-42 percent and up to 67-85 percent for those admitted to the intensive care unit.
Prior to the COVID-19 outbreak, ARDS affected approximately 200,000 patients per year in the United States, resulting in nearly 75,000 deaths per year, and it accounts for 10% of intensive care unit admissions worldwide, said the society.
Treatment of ARDS consists primarily of respiratory support, such as mechanical ventilation.
High-dose steroids are also used to relieve symptoms, but no extensive studies have proven the effectiveness of high-dose steroids in treating and preventing its escalation, said Foresee.
Foresee’s FP-025 is described as a highly selective inhibitor of MMP-12 (macrophasic elastase), which has been identified as a component responsible for lung damage and fibrotic conditions in the lungs of COVID-19 patients.
He said in a previous statement that FP-025 “has been shown to have effects in preclinical models of inflammation and fibrosis of the lung, making it a promising treatment for inflammatory airway disease.” .