PARIS--(BUSINESS WIRE)--Kinnov-Therapeutics (https://www.kinnov-therapeutics.com/), a biopharmaceutical company specialized in the development of innovative treatments for addiction, today announced the completion of patient enrollment in its Phase 2 clinical trial (study COKTAIL) evaluating its lead drug candidate, KT-110, in its first program, alcohol use disorders.
Kinnov-Therapeutics, is at the origin of the first patented drug, based on the pioneering work of Prof. Jean-Pol Tassin, who showed that the selective and simultaneous modification of noradrenergic and serotonergic receptors can counteract the neurobiological processes involved in addiction by regulating the secretion of dopamine. The founders of KINNOV have shown that the combination of cyproheptadine and prazosin has therapeutic effects in experimental models of addiction. KT-110 is composed of these two molecules and exerts its therapeutic effect on addiction, rather than through a substitution effect. The combination of the two molecules regulates the reward system allowing patients to regain control of their alcohol consumption, with the objective of significantly reducing or even stopping it. In animal models, KT-110 has already shown greater efficacy than standard treatments (Nalmefene, Naltrexone and Baclofene) on alcohol consumption.
This Phase 2 clinical trial is a multicenter, randomized, double-blind, placebo-controlled trial including patients with severe alcoholism and comparing 3 groups of treatment: KT-110 administered orally 3 times a day for 12 weeks in 2 different doses (cyproheptadine 8 mg/day or 12 mg/day and prazosin 5 mg/day or 10 mg/day), and a placebo group. This study was conducted in 34 study centers across France and supervised by its principal investigator, Professor Henri-Jean Aubin (Paul Brousse Hospital, Villejuif). To date, 180 patients have been randomized to the two treatment groups: 60 in the low-dose group and 60 in the high-dose group, and 60 the placebo group. The primary endpoint of this study, as recommended by the EMA, is the reduction of total alcohol consumption (TAC) in alcohol-dependent patients. The first results of the study are expected in the first quarter of 2022. At that time, Kinnov-Therapeutics will seek a partner to launch a large-scale Phase 3 trial allowing a market launch between 2025 and 2026.
According to the WHO :
- 91 million human beings are estimated to suffer from alcohol abuse disorders worldwide.
- Alcohol is the third leading morbidity risk factor after high blood pressure and tobacco, killing 3 million people each year (one in 20 deaths).
- The annual cost of alcohol in the United States ($249 billion)
