Kinnov-Therapeutics completes recruitment of KT-110 Phase 2 clinical trial in alcohol dependence disorders

Kinnov-Therapeutics completes recruitment of KT-110 Phase 2 clinical trial in alcohol dependence disorders

This study evaluates the efficacy, safety and tolerance of KT-110, a combination of 2 molecules protected by a compositional patent, on alcohol consumption in patients suffering from severe alcoholism

KT-110, a new and innovative approach based on dual receptor targeting

First study results expected in the first quarter of 2022

Paris, August 30 2021 - Kinnov-Therapeutics, 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.

The first patient in this study^[i] was enrolled on November 30, 2019 and the last patient at the end of June 2021. 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.

Professor Henri-Jean Aubin (Paul Brousse hospital), principal investigator of the study: « The medical need is very high, as we are currently insufficiently equipped in the pharmacological management of our patients with alcohol addiction. The COKTAIL trial is testing a promising new concept for these patients, with encouraging preclinical results. Thanks to the outstanding involvement of more than 30 investigating centers throughout France, we have been able to complete the recruitment of patients, despite the difficulties caused by the COVID-19 crisis. I thank them for their involvement."

"We have just reached an important milestone with the completion of enrolment in our Phase 2 study evaluating our drug candidate KT-110 in patients suffering from severe alcoholism. Our original and unique mode of action - it acts on two receptors - combined with the synergistic effect of the two molecules of KT-110 allows us to intervene directly without affecting the reward system. KT-110 resensitizes the receptors desensitized by alcohol and located upstream of the reward system and the release of dopamine. The simultaneous modification of these 2 receptors suppresses the addictive effects of alcohol by acting at the very heart of the process - the addiction - while avoiding side effects such as those produced by antipsychotics", underlines Prof. Alain Puech, Medical Director of Kinnov-Therapeutics.

"The completion of enrollment in this Phase 2 evaluating KT-110, our lead drug candidate, is a major milestone for Kinnov-Therapeutics. Alcohol dependence is a key public health issue and the medical needs for the treatment of alcoholism are still huge and unmet, but no new drug has been brought to market since 2013. Alcoholism is a crippling disease that is expensive to treat and kills 3 million people each year. With KT-110, we hope to make a real difference in the care and quality of life of patients suffering from the severe consequences of alcoholism. We are looking forward to the results of KT-110 expected in the first quarter of 2022, which will allow us to pursue our ambition of a strong and value-creating industrial partnership to move forward on a phase 3", adds Mr. Emmanuel de Rivoire, CEO of Kinnov-Therapeutics.

About alcoholism

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)

In France, according to figures from the Ministry of Solidarity and Health

Alcohol kills 49,000 people per year

Alcohol consumption represents a major public health issue with an estimated social cost of $120 billion (Social cost of drugs in France", Pierre Kopp OFDT).

Alcohol consumption is also the leading cause of hospitalization in France.

France remains one of the world's highest alcohol consumers, ranking sixth among the 34 OECD countries (World Health Organization Global status report on alcohol and health 2018).

About Kinnov-Therapeutics (https://www.kinnov-therapeutics.com/ )

Founded in Orleans in 2015 by Greenpharma and Key-Obs, Kinnov-Therapeutics is a biopharmaceutical start-up. The company has developed an innovative and novel mechanism of action based on the combination of two molecules (cypropheptadine and prazosin against hypertension and allergies) to fight addictions by regulating dopamine secretion. They have developed a first innovative drug candidate, KT-110, to fight alcohol addiction, which has just completed its phase 2b. KINNOV-THERAPEUTICS is supported by the Conseil Général Centre Val de Loire, the BPI, and the European Union (Horizon 2020 program).