FDA Grants Orphan Drug Designation to XW Laboratories' XWL-008 for the Treatment of Patients with Narcolepsy

PR79348

WUHAN, China, June 24, 2019 /PRNewswire-AsiaNet/ --

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."

The FDA Orphan Drug Designation program grants orphan status to promising

investigational drugs designed to treat, prevent, or diagnose rare medical

diseases or conditions that affect fewer than 200,000 individuals in the United

States. Orphan designation qualifies sponsors for several key benefits and

incentives, including tax credits for clinical testing, exemption from marketing

application user fees, and seven-year marketing exclusivity upon FDA approval.

About Narcolepsy

Narcolepsy is a chronic neurological sleep disorder in patients with abnormal

regulation of their sleep-wake cycle. This disorder is typically characterized

by excessive daytime sleepiness and cataplexy (sudden muscle weakness triggered

by emotion), among other symptoms. Approximately 1 in 2,000 individuals in the

US as well as 3 million individuals worldwide suffer from this disorder.

About XW Laboratories Inc.

XW Laboratories Inc. (XW Labs) is a clinical-stage biopharmaceutical company

focused on the development of novel compounds for the treatment of neurological

disorders with primary research and development activities located in Wuhan,

Mainland China and New Taipei City, Taiwan. XW Labs' expertise in drug design

and specialized drug platforms provide critical competitive advantages to

shortening the time it takes to identify best-in-class development candidates.

SOURCE: XW Laboratories Inc.