Cannabisoid new drug treatment is gratifying, significantly improving the symptoms of neurological diseases

Cannabisoid new drug treatment is gratifying, significantly improving the symptoms of neurological diseases

April 11, 2018 Source: WuXi PharmaTech

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Recently, Therapix Biosciences, a biopharmaceutical company focused on the development of new cannabinoids, announced the results of its phase 2a clinical trial of THX-110 at Yale University. The study showed that THR-110 significantly improved the symptoms of adult subjects in Tourette syndrome (TS).

Torre's syndrome (TS) is a tic syndrome (Tic), a neurological disease that occurs more frequently in children and adolescents. The patient will involuntarily make a sound or shake the body. It is estimated that the annual incidence of the disease is 5-10 patients per million people. The disease can cause mental stress and behavioral disorders in patients. Many of the severe symptoms of patients affected by TS at an early age continue into adulthood. Having TS can pose a unique set of challenges for adults. They often lack the support of families and relatives of young TS patients. Social prejudice and discrimination also make it difficult for adults with TS to have drugs. Improve their condition.

The drug THX-110, developed by Therapix based on cannabinoid-based drugs, has demonstrated prima facie evidence that can alleviate the symptoms of TS adult patients. Cannabinoids, also known as cannabinoids, are a group of indole phenolic compounds found in Indian cannabis, and cannabinoid receptors are present in the human brain and immune system. In the medical field, cannabinoids are used to control symptoms such as epilepsy, mental illness, and chronic pain. THX-110 developed by Therapix is ​​a combination of dronabinol (synthetic cannabinoid) and palmitoylethanolamide. In addition to TS, THX-110 is also evaluated in terms of obstructive sleep apnea and pain management.

According to Therapix, in a one-arm, open-label phase 2a clinical trial designed to confirm drug safety, tolerability, and feasibility, 6 of 16 TS patients treated with THX-110 showed significant improvement. Their condition was assessed according to the Yale Global Tic Severity Scale Total Tic Score, and the score was reduced by more than 25% after 12 weeks. Researchers from Yale University also reported a mean difference of up to 7.9 (from 38.4 to 30.5), which means that the average twitch was reduced by 21%. Tic is the patient's repeated unconscious movements and sounds, which is a disease characteristic of TS.

â–²Therapix Biosciences R & D pipeline (Source: Therapix Biosciences official website)

Dr. Michael H. Bloch, the principal of the trial and associate professor at the Children's Research Center at Yale University, believes that this result is encouraging because these patients have previous treatments (such as antipsychotics and behavioral therapy) or experimental therapies (such as topiramate). Or deep brain stimulation) did not respond.

Although these positive results are more gratifying, because it is a one-arm test, the importance of the results has not yet been determined. Therapix now plans to include THX-110 in a randomized, double-blind, placebo-controlled clinical study to evaluate its efficacy. In addition, the company also announced a 24-week extension trial, with 12 of 16 patients agreeing to participate in the extended trial.

Dr. Ascher Shmulewitz, Chairman and Interim CEO of Therapix, said in a statement: "We believe that the efficacy demonstrated by this study further underscores the potential role of cannabinoids in the central nervous system and dyskinesia and suggests that Therapix may develop A proprietary cannabinoid product that can be used to treat TS."

Reference materials:

[1] Therapix shares rise on early data of its repurposed cannabinoid in Tourette syndrome

[2] Tourette Association of America

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