Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) announced that Zygel, its experimental cannabis-derived gel, failed to show significant improvement in patients’ aberrant behavior, who are suffering from Fragile X Syndrome, a neurological disorder. Following the news, its shares dropped by almost 48.5% on June 30, 2020 before the opening bell to $3.37.
Zygel, a synthetic version of CBD, failed to satisfy the secondary targets at 12-week in a study involving 212 patients. The 14-week trial is conducted to find the efficacy of the drug to treat Fragile X syndrome in adolescents and children. Zynerba will approach the US FDA for further progress on Zygel to meet the desired objective.
Zygel to benefit patients with severe Fragile X syndrome
In a preplanned Adhoc study conducted on patients severely impacted, Zygel showed significant improvement at the 12th week in primary endpoint in SAS (socially avoidable subscale) of the ABC-CFXS comparing with placebo. Zynerba carried out the trial on 80% of the patients, who registered in the CONNECT-Fx trial.
A key investigator of the clinical study, Randi J. Hagerman, said the company identified a patient group who could benefit from using Zygel. Therefore, the drug could provide a vital therapeutic benefit to the patients suffering from severe Fragile X.
CEO and Chairman of Zynerba, Armando Anido, said the clinical trial helped to detect a patient group who could benefit from treatment using Zygel. The company will discuss the findings of the drug with the US FDA and seeks further direction.
Safety of the drug
The patient, who registered in the CONNECT-FX trial, well-tolerated the drug – Zygel and no safety issues observed during the trial.
Reports net loss of $12.3 million in Q1 2020
In Q1 2020, Zynerba posted a loss of $12.3 million. It is on the backdrop of remeasurement of the liabilities and assets of its subsidiary in Australia. The company has sufficient funds to carry out business activities beyond the anticipated NDA submission of Zygel. It also has sufficient cash to conduct operations into Q2 2021.
Zynerba implemented several measures to ensure patients’ safety. It also adhered to stringent guidelines offered by the health authorities to protect its employees and clinical investigators.
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