New pre-clinical data shows that a low dose of a proprietary tetrahydrocannabinol (THC) drug candidate developed by Israel’s Therapix Biosciences significantly reversed age-related cognitive impairment in old mice.

Therapix focuses on the development of cannabinoid-based drugs. The candidate dubbed THX-ULD01 is intended for the treatment of mild cognitive impairment (MCI).

MCI is an intermediate stage between the expected cognitive decline of normal aging and the more serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes but are not severe enough to interfere with daily life or independent function.

The pre-clinical animal study was designed and conducted by Prof. Yosef Sarne of the Sackler Faculty of Medicine at Tel Aviv University.
“The data from this pre-clinical animal study suggest that extremely low doses of THC, which are devoid of any psychotropic effect and do not induce desensitization, could potentially provide a safe and effective treatment for cognitive decline in aging humans,” said Sarne.

In the study, 24-month-old female mice were injected once with 0.002 mg/kg of the compound, which is much lower than doses that induce the conventional cannabinoid effects in mice. These treated mice performed similarly to 2-month-old mice in six different behavioral assays that measured various aspects of memory and learning. The beneficial effect lasted for at least seven weeks.

“The model demonstrated a relatively long-lasting increase in neuroprotection and neuroplasticity, as well as a larger volume and higher tissue density in various regions of the brain of THC-treated old mice as measured by MRI,” said Sarne.

Therapix CTO Adi Zuloff-Shani said these promising data “further demonstrate the clinical and commercial potential of THX-ULD01 for the treatment of MCI. Based on the discovery of significantly improved therapeutic impact at ultra-low doses of THC, it is our continued belief that THX-ULD01 has the potential to fulfill the growing unmet medical need in MCI.”

Zuloff-Shani said the pre-clinical models are expected to be followed by human trials for this potential first-in-class therapy.
Sarne’s findings will be published in Neurobiology of Aging and were presented at the International Association for Cannabinoid Medicines’ Conference on Cannabinoids in Cologne, Germany, on September 29-30.