Shares in Zynerba Pharma (ZYNE) jumped 6.4% in Thursday’s trading, and continued to climb 1.6% after-hours, after new data from the Phase 2 Bright trial showed the potential for Zygel (ZYN002) to improve behavioral symptoms of autism alongside stable standard of care in children and adolescents with moderate-to-severe autism spectrum disorder (ASD).
“The Phase 2 BRIGHT trial provides the first clinical evidence of the potential for Zygel to improve behavioral symptomology in a group of highly symptomatic pediatric and adolescent patients with ASD,” said Helen Heussler, principal investigator in the trial.
“In these children receiving Zygel, the observed changes from baseline are promising. In particular, the improvements seen in core symptoms of autism, as specifically assessed by the Autism Impact Measure, are of special interest” she added.
The BRIGHT Phase 2 trial is an exploratory, single-center, open-label Phase 2 study evaluating the safety and tolerability and efficacy of Zygel in children and adolescents with ASD who are 3 to <18 years old.
New data presented revealed that patients receiving Zygel achieved statistically significant caregiver-reported improvements compared to baseline across the core ASD symptoms, namely: Atypical behavior, Communication, Peer Interaction, Repetitive Behavior, and Social Reciprocity.
In addition, statistically significant improvements compared to baseline were observed at week 14 of treatment with Zygel in the Autism Parenting Stress Index.
Zynerba also measured notable improvements in behaviors utilizing the Qualitative Caregiver Behavioral Problems Survey after 14 weeks of study drug. Clinically meaningful improvements were observed by a majority of surveyed caregivers in behavioral, social and emotional behavioral problems.
Zygel was also very well tolerated and the safety profile was consistent with previously released data from other Zygel clinical trials. No serious or severe adverse events were reported.
Zynerba focuses on pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders including Fragile X syndrome and developmental and epileptic encephalopathies. (See ZYNE stock analysis on TipRanks)
Shares in the company have plunged 37% year-to-date, but the stock scores a bullish Strong Buy Street consensus with 3 recent buy ratings vs 1 hold rating. Meanwhile the average analyst price target stands at $13 (242% upside potential).
“We continue to believe ZYNE is offering investors a compelling entry point this fall when paired against its peers: including Zogenix and Stoke” comments Ladenburg Thalmann analyst Michael Higgins. He has a buy rating on the stock and $15 price target.
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