Zynerba Pharmaceuticals has reported negative top line results from a Phase l clinical trial evaluating its tetrahydrocannabinol (THC) pro-drug ZYN001 for undisclosed indications after the trial failed to meet its target.
The trial was designed to examine the safety and pharmacokinetics of several formulations of ZYN001 in single and multiple doses.
As part of the placebo-controlled and first-in-man trial, 60 healthy subjects were randomised to receive either ZYN001 or placebo.
The drug was delivered via a transdermal patch over a period of time that ranged from 24 hours to 14 days.
However, the top line results showed that the trial was unable to achieve the target level of 5ng/ml to 15ng/ml of THC in blood.
ZYN001 was reported to be well tolerated with minimal skin erythema, and did not cause any serious adverse events or discontinuations for subjects receiving the drug.
Zynerba Pharmaceuticals said in a statement: “As a result of this data, the company will focus its development efforts and investments on the ZYN002 Fragile X syndrome, developmental and epileptic encephalopathy (DEE) and adult refractory epilepsy programmes.
“The company expects that this change will extend its cash runway into the second half of 2019.”
Zynerba Pharmaceuticals is primarily involved in the development of pharmaceutically produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders.
The company also aims to support the lives of patients and their families living with severe, chronic health conditions such as Fragile X syndrome and refractory epilepsies.