The company said in a statement, “The U.S. Patent and Trademark Office has issued US Patent No. 10,213,390, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company’s cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD gel.”
The company said that the issuance of this patent comes as enrollment progresses in CONNECT-FX, a pivotal, multi-national, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ZYN002 in three through 17-year old FXS patients with a full mutation of the FMR1 gene. The primary endpoint is the change from baseline to the end of the treatment period in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale.
Zynerba said in a statement that clinical investigative sites are enrolling patients in the United States, Australia, and New Zealand. Patients who have completed the double-blind phase are now enrolling into the 12-month open-label phase. The company expects to report top-line data in the second half of 2019.
This follows the company recent news that the International Intellectual Property Organization issued a patent on a Zynerba’s CBD-based drug to treat osteoarthritis. Zynerba had conducted a study that showed that CBD could be an effective treatment for patients suffering from osteoarthrits. The administration of a CBD transdermal gel showed an improvement in pain. This patent will allow Zynerba to tap into a large osteoarthritis market occupied primarily by opioids
2018 wasn’t especially kind to Zynerba. It’s failed ZYN001 drug was a huge setback. Then the company’s stock offering was met with dismay by investors. Many felt the company had enough cash to see it through additional R&D and that it didn’t need to add more shares to the mix. Zynerba planned to use the net proceeds of the offering to support the clinical development of ZYN002