WUHAN, China, June 24, 2019 /PRNewswire/ -- XW Laboratories Inc. (XW Labs), a clinical-stage biopharmaceutical company pioneering the discovery of novel small molecule therapeutics for the treatment of neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's lead proprietary compound XWL-008 for the treatment of patients with narcolepsy.
"We are delighted to receive Orphan Drug Designation for XWL-008 for the treatment of narcolepsy. We continue to be committed to the development of XWL‑008 as the potential first-line treatment for this rare and debilitating disorder," said Dr. Jia-Ning Xiang, Founder and CEO of XW Labs. "We have recently reached a major milestone in XWL-008 development by successfully completing Phase 1 studies, yielding robust results demonstrating favorable safety, tolerability, and pharmacokinetics. We are now preparing for late-stage phase 3 clinical research and a 505(b)(2) NDA regulatory pathway as the next step to bringing this novel drug candidate to narcolepsy patients worldwide."