Doctors may soon have a better option for managing an often-fatal lung condition called acute respiratory distress syndrome, a small trial of an experimental antibody drug suggests.
In ARDS, injuries or infections trigger an inflammatory cascade that results in fluid leaking into the lungs, causing oxygen levels in the blood to plummet.
An estimated 500,000 people a year are diagnosed with ARDS in the United States, and 40% of them die, the researchers who conducted the trial said in a statement.
“There are no FDA-approved therapies to give these patients, and given the unacceptable mortality and pervasiveness of the disease, ARDS treatment remains one of the greatest unmet needs in medicine,” study leader Dr. Joe G.N. Garcia of the University of Florida Scripps Research Institute said in a statement.
In the proof-of-concept U.S. study, 15 patients were randomly assigned to receive the monoclonal antibody called ALT-100 being developed by Aqualung Therapeutics with help from National Institutes of Health grants, or a placebo.
ALT-100 targets an important regulator of inflammation called NAMPT.
Over a period of 28 days, the ALT-100 group needed mechanical ventilation to help with breathing an average of seven days, compared to 14 days for the placebo group.
The ALT-100 group also had lower levels of inflammatory markers in their blood and fewer cases of organ failure, which is the main cause of ARDS fatalities, according to the report published in the American Journal of Respiratory and Critical Care Medicine.
Safety issues were similar in the two groups, the researchers said.
“Even though we were only able to enroll 15 patients, the data we are getting is simply incredible,” said Garcia, Aqualung's founder and CEO.
Garcia said he is seeking funding for a larger clinical trial and has a green light from the U.S. Food and Drug Administration to study ALT-100 in patients with progressive pulmonary fibrosis, a buildup of scar tissue in the lungs.
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