CORONAVIRUS/Pharma company announces potential new drug for COVID patients
Taipei, July 5 (CNA) A new drug developed by Taipei-based Foresee Pharmaceuticals Co. to treat acute respiratory distress syndrome (ARDS) in COVID-19 patients has received the approval of an independent data monitoring committee (IDMC) in the United States.
In a filing with the Taiwan Stock Exchange, Foresee announced that it 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 patients who have ARDS.
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 currently is no available medication to treat ARDS and lung fibrosis, and if successfully developed, FP-025 will be a first-in-class therapy for ARDS, according to Foresee.
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 into Phase 3 with potential modifications to the research protocol, it said.
Approximately 99 patients are taking part in the current trial in the U.S., and the 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 Central and South American countries, Foresee said.
At present, about 3-17 percent of COVID-19 patients develop ARDS, the company said, citing U.S. Centers for Disease Control data.
Among hospitalized patients, that number increases to 20-42 percent and up to 67-85 percent for those admitted to the intensive care unit.
Before the COVID-19 outbreak, ARDS affected approximately 200,000 patients a year in the U.S., resulting in nearly 75,000 deaths annually, and it accounts for 10 percent of intensive care unit admissions globally, the company said.
Treatment for ARDS primarily consists of breathing support, such as mechanical ventilation.
High-dose steroids are also used to alleviate the symptoms, but no extensive study has proven the effectiveness of high-dose steroids in treating and preventing its escalation, Foresee said.
Foresee's FP-025 is described as a highly selective inhibitor of MMP-12 (macrophase elastase), which has been identified as a component in causing pulmonary injury and fibrotic conditions in the lungs of COVID-19 patients.
It said in a previous statement that FP-025 has been shown "to have effects in preclinical inflammation and fibrosis models of the lung, making it a promising treatment for inflammatory airway diseases."
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