The , according to an announcement issued by the company that is developing the treatment.
The company, Immune Pharmaceuticals, plans to launch a pivotal phase 2/3 study in 2019, the company said in an Aug. 20 press release. Two phase 2 studies of bertilimumab are currently underway, one in patients with bullous pemphigoid, and another in patients with ulcerative colitis. Bertilimumab is “a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation,” the statement said.“By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions.”
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The FDA’s Orphan Drug Designation program grants orphan status to drugs and biologics, which are “defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug,” according to the agency.