On Thursday, shares of clinical-stage specialty pharmaceutical company Zynerba Pharmaceuticals (NASDAQ:ZYNE) are soaring, up nearly 54% in afternoon trading after it announced positive results in a mid-stage study of its cannabis-derived gel treatment.
The drug, ZYN002, is a cannabidiol gel that seeks significantly reduce symptoms in patients who suffer from fragile x syndrome. Fragile x is an autism-spectrum disorder, and causes a range of developmental problems like learning disabilities and cognitive impairment. Symptoms include anxiety and hyperactive behavior such as fidgeting or impulsive actions.
According to the U.S. National Library of Medicine, fragile x affects males more severely than females, and 1 in 1,400 males and 1 in 1,800 females are affected; there is no approved treatment.
“The data from the FAB-C trial are very exciting and demonstrate that ZYN002 may have a profound effect on improving many of the most disabling symptoms of Fragile X, such as anxiety and difficult behaviors,” said Steven Siegel, MD, PhD Professor and Chair, Psychiatry and Behavior Sciences, Keck School of Medicine of USC.
Zynerba’s mid-stage study successfully met its primary endpoint, and the trial’s 20 patients, aged 6-17, experienced a 46% improvement in symptoms on the Anxiety, Depression, and Mood Scale (ADAMS) at week 12 compared to the baseline. The gel treatment also improved certain behaviors associated with fragile x, like temper tantrums, social avoidance, repetitive movements, and hyperactivity.
Looking ahead, Zynerba said it will test ZYN002 against a placebo in another mid-stage trial with more patients. The company expects to meet with the FDA during the first half of next year.
A #3 (Hold) on the Zacks Rank, ZYNE has lost over 65% in value year-to-date.
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Zynerba Pharmaceuticals, Inc. (ZYNE): Free Stock Analysis Report
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