Phase Two of their cannabidiol (CBD) gel for the treatment of patients with adult epilepsy has begun.
Zynerba Pharmaceuticals, a pharmaceutical company specializing in the development of synthetic cannabinoid treatments, announced on the first of August that it had begun phase two clinical trials of its CBD gel ZYN002.
The gel has been developed to treat adult epilepsy patients who experience refractory focal seizures.
Chairman and CEO of Zynerba, Armando Anido, stated in a press release that the dosing of the first patients in the STAR 1 clinical trial was a significant milestone for the company. He went on to say that they were pleased by the pace of the clinical program for ZYN002.
How Does the Gel Work?
The CBD gel is the first synthetic CBD developed as a permeation-enhanced gel applied directly to the skin for transdermal delivery. In addition to the tests for treating epilepsy, it is also under development and in testing for the treatment of osteoarthritis and Fragile X syndrome.
Zynerba’s CEO has stated that the top-line results from each of these three studies should be expected during the first half of 2017.
The ZYN002 gel is made up of a synthetic cannabidiol. Previously, it has been shown to reduce the frequency of seizures in patients with drug-resistant epilepsy. The clear gel, which was designed to be absorbed directly into the skin, is administered in consistent, controlled doses, twice a day.
Absorption into the skin allows the gel to directly enter the systemic circulation, therefore avoiding the liver and gastrointestinal system and subsequent stomach acid degradation of the CBD into THC (which is associated with psychoactive effects).
This application method also means lower doses can be administered.
What Will Phase Two Involve?
The Phase Two trial will seek to analyze the effect of Zynerba’s ZYN002 gel in 180 adult patients currently struggling with refractory, or drug-resistant, epilepsy in Australia and New Zealand.
For the first eight weeks of the trial, researchers will carefully evaluate the frequency, type, and severity of seizures in the epileptic patients.
Once the baseline period has elapsed, the patients will be randomized into three groups. One will receive a dose of 195 mg of ZYN002 4.2% CBD gel; one will receive a 97.5 mg dose of the same gel; and one will receive a placebo gel. All three treatments will be administered every 12 hours for a period of 12 weeks.
The aim of the study is to evaluate changes in seizure frequency in these patients throughout the trial period, in addition to observing and better understanding the safety and tolerability of the drug.
What Is Epilepsy?
Epilepsy is characterized by recurrent, unprovoked seizures. A chronic disorder and the fourth most common neurological disorder, it currently affects an approximate 2.2 million patients in the United States alone with a further 3.1 million across Europe and Japan also impacted.
The most common type of seizure is a focal seizure, which makes up 35% of all epilepsies. These usually start in a small area of the temporal or frontal lobe of the brain but have been known to involve other areas too.
Seizures can impact the safety as well as the professional and personal lives of patients. Driving can be dangerous and holding down a job difficult. In fact, the way in which epilepsy is perceived by those who do not understand it can often be a bigger problem than the seizures themselves.
If a person experiences one or more seizures not caused by a known and reversible medical condition, such as extremely low blood sugar or alcohol withdrawal, then he or she will likely be diagnosed with epilepsy.
The seizures may be related to a previous brain injury or family history of the condition, but more often than not, the cause is completely unknown. The word “epilepsy” does not suggest anything about the cause of the seizures nor the severity.
What Is Fragile X Syndrome?
A genetic condition that causes a number of developmental issues, including learning disabilities and cognitive impairment, Fragile X Syndrome is another condition that Zynerba hopes to be able to treat with their CBD gel.
Male patients are usually more severely affected by the disorder than female patients, and those affected will usually experience delayed development of speech and language. Most male patients diagnosed with Fragile X Syndrome will present mild-to-moderate intellectual disabilities while around one-third of female patients are found to be intellectually disabled.
Young children with Fragile X Syndrome may present with hyperactive behavior and anxiety, and they may also have attention deficit disorder, which typically includes an impaired ability to maintain attention and a difficulty to focus on specific tasks.
Around one-third of sufferers present features of autism disorders that impact their ability to communicate effectively and interact socially. Seizures can also occur with around 15 percent of male patients and 5 percent of female patients experiencing them.
A Little Bit About Zynerba Pharmaceuticals
Based in Devon, Pennsylvania, and founded in 2014, Zynerba Pharmaceuticals is focused on the development and commercialization of proprietary next-generation synthetic cannabinoid therapeutics designed specifically for transdermal delivery.
If the trial is successful, Zynerba hopes that their CBD gel will allow a sustained, consistent, and controlled delivery of a therapeutic level of two cannabinoids: the non-psychoactive cannabidiol and tetrahydrocannabinol (THC).
They believe that the method of transdermal delivery has the potential to counteract the adverse effects associated with oral dosing of similar CBD and THC products.
In addition to the ZYN002 CBD gel, Zynerba is also developing ZYN001, which utilizes a synthetically manufactured version of THC that is delivered through the skin and into the circulatory system via a patch.
The first phase of clinical studies for ZYN001 is scheduled to begin in the second half of 2016.
What do you think of Zynerba’s proposed CBD gel? Do you believe the method of transdermal delivery of CBD is preferable to taking it orally? Let us know your thoughts in the comment section below.