THX-110: A Proprietary Combination of THC and PEA
THX-110 is a drug candidate platform for the treatment of symptoms related to Tourette syndrome (TS), as well as Obstructive Sleep Apnea (OSA) and chronic pain.
TS is a neuropsychiatric disorder starting in childhood. Symptoms include multiple physical and at least one vocal tic that can be disabling and associated with hyperactivity, anger control problems, sleep disorders, and obsessive-compulsive behavior. Some of the most dramatic and disabling tics include motor movements that result in self-harm or vocal tics including coprolalia or echolalia. Current pharmacological treatments have provided very limited efficacy and are almost always accompanied by severe side effects. To date only 3 drugs are approved by the FDA for the treatment of TS patients. However, exposure to these drugs is associated to severe side effects, which may limit their tolerability and use in many TS patients.
Therapix completed an Investigator Initiated Phase IIa study at Yale University, suggesting that THX-110, which is a combination of THC and PEA, significantly improved symptoms over time in adult Subjects with Tourette syndrome.
The study was a single-arm, open-label trial, in which each subject both received one daily treatment of the drug via oral administration and was followed-up for a period of 12 weeks. Sixteen subjects participated in the study and received THX-110 at the Yale University Child Study Center at Yale University, USA. The primary endpoint of the study was to assess the performance of THX-110 in the treatment of adult patients suffering from symptoms of Tourette syndrome, as measured by the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS), the gold-standard and customary index for assessing symptom severity. Treatment was given in a dose titration regimen with a maximum dose of THX-110 consisting of 10mg Dronabinol and 800mg PEA.
The study showed that these 16 subjects with medication-refractory TS had an average tic reduction of 21% across the entire sample. Six of the 16 medication-refractory TS subjects experienced a response to treatment as defined by a reduction in YGTSS-TTS of greater than 25%. The medication was generally well-tolerated.
The study was investigator-initiated and led by Michael H. Bloch, M.D., Associate Professor at the Yale University Child Study Center, and James F. Leckman, M.D., Ph.D., of the Neison Harris Professor in the Child Study Center and Professor of Pediatrics Child Psychiatry at Yale University.
Therapix is initiating a Phase IIb clinical trial in two centers in Germany, Hanover and Munich, which will evaluate the safety and efficacy of THX-110 for the treatment of symptoms of Tourette syndrome. This study is intended to be double-blind, randomized, and placebo controlled.
Therapix is seeking orphan drug designation for this compound.
Obstructive Sleep Apnea
OSA is a potentially serious sleep disorder. It causes breathing to repeatedly stop and start during sleep. There are several types of sleep apnea, but the most common is obstructive sleep apnea. This type of apnea occurs when the throat muscles intermittently relax and block the airway during sleep. A noticeable sign of obstructive sleep apnea is snoring. OSA affects 29.4 million American men and women, which represents 12 percent of the U.S. adult population. There are currently no approved pharmaceutical approaches. The standard treatments for obstructive sleep apnea (OSA) are noninvasive ventilation devices (CPAP) and oral appliances that are very inconvenient to the patient, thus result in low compliance.
Therapix initiated a Phase IIa sponsor-initiated clinical trial using the Company’s cannabinoid-based technology THX-110 for Obstructive Sleep Apnea (OSA), at Assuta Medical Center, the largest private hospital network in Israel.
The clinical trial is a single-arm, open-label trial, in which 30 subjects receive one daily treatment of the drug via oral administration and is followed-up for one month with the primary efficacy endpoint evaluating a significant change in the AHI (apnea-hypopnea index – which refers to the severity of sleep apnea as measured during a sleep test), which assesses the quality of sleep before and after treatment. The clinical trial is designed to prove the safety, tolerance and efficacy of the drug’s treatment, and to assess its performance in adult patients suffering from symptoms of Obstructive Sleep Apnea.
Pain is a distressing feeling often caused by intense or damaging stimuli. Pain is the primary reason why people seek medical care; more than 40% of the US population is affected by chronic pain. There are two main classifications of pain: the common sensical sort that arises from damaged tissue (nociceptive pain), and the more exotic kind that comes from damage to the system that reports and interprets damage, the nervous system (neuropathic pain). Pain can also be classified as acute or chronic. Acute pain is provoked by a specific disease or injury, is associated with skeletal muscle spasm and sympathetic nervous system activation. Chronic pain, in contrast, may be considered a disease state. It is pain that outlasts the normal time of healing, if associated with a disease or injury. When treating moderate to severe pain, the type of the pain, acute or chronic, needs to be considered. The type of pain can result in different medications being prescribed.
The Phase IIa Clinical Trial titled “Examining the Efficacy of THX-110 [Dronabinol (synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide (PEA)] for Chronic Low Back Pain” is a single-arm, open-label trial, in which each subject receives one daily treatment of the drug via oral administration and is followed-up for a period of 6 weeks with an additional 2 weeks follow up after the last study treatment. Approximately 20 subjects are expected to participate and receive the drug in the context of the Clinical Trial. The primary endpoint of the Clinical Trial is to prove the safety, tolerance and efficacy of THX-110 in the treatment of adult patients suffering from chronic low back pain, with efficacy measured by the improvement of quality of life outcomes.