Key Milestone with Lead Drug KT-110 for Alcohol Use Disorder

KINNOV Therapeutics has reached a key clinical milestone for treatment of Alcohol Use Disorder with a Phase 2 clinical study for its game changing drug KT-110.

PARIS, FRANCE, June 9, 2022 /EINPresswire.com/ — KINNOV Therapeutics (“Kinnov”) announces it has reached a major milestone for treatment of Alcohol Use Disorder (AUD) with promising Phase II clinical study results for its game changing drug KT-110. Alcoholism is a major public health issue with a strong unmet medical need.

Kinnov has appointed The Sage Group (www.sagehealthcare.com) to seek a commercial partner for the next phase of clinical development and market approval for KT-110 on a global basis.

According to the World Health Organisation, 91 million people worldwide suffer from alcohol-related disorders. Alcohol is the third leading risk factor for morbidity, killing 3 million people each year. In the 20-40 age group, 1 in 4 deaths is related to alcohol overconsumption. The total annual cost of alcohol abuse in the United States alone is $250 billion. (WHO and National Institute on Drug Abuse).

Today, the available treatments are unsatisfactory due to the limited effectiveness and poor tolerance of available drugs.

KINNOV Therapeutics is based in Paris and has designed the innovative drug KT-110 which is widely protected a composition-of-matter patent. This innovation is the invention of Prof. Jean-Pol Tassin (Inserm & Collège de France, Paris). KT-110’s mode of action is the simultaneous modulation of noradrenergic and serotonergic brain receptors which counteracts the neurobiological processes involved in addiction regulating the secretion of dopamine.

KT-110 combines two well-known drugs (cyproheptadine and prazosin) acting on these key receptors. It is taken once a day in a single oral tablet.

In preclinical models, KT-110 has already been shown to be more effective than standard treatments such as Nalmefene, Naltrexone and Baclofene in reducing alcohol preference.

By regulating the brain’s reward circuit, KT-110 allows patients to regain control of their alcohol consumption, to significantly reduce or even stop it

KINNOV has announced successful completion of a multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial (“Cocktail”) which included 154 patients suffering from severe alcoholism. This study was conducted in 34 investigating centers across France. The primary endpoints were reduction in alcohol consumption, with secondary endpoints being the number of days of high consumption (HDD), craving and depression.

The Cocktail study with KT-110 concluded the standard dose is well tolerated and has an effect on alcohol consumption, on the number of heavy drinking days and on criteria associated with alcohol addiction. The efficacy of KT-110 is more marked in patients who are heavy drinkers.

Together, these clinical data confirm the value of the combination of the two active ingredients cyproheptadine and prazosin in KT-110.

The Phase 2 study has provided insights into the design of a Phase III clinical development plan that meets the registration and market access requirements for KT-110. A new once-daily formulation of KT-110 will be available for the Phase 3 study, thus offering improvements to treatment and ease of use for patients.

Professor Henri Jean Aubin, Principal Investigator for the KT-110 study, said “The diversification of the therapeutic arsenal for the management of alcohol-dependent patients is imperative because we are still disarmed this pathology. KT-110, whose mode of action is totally new, confirms that a new therapeutic approach is emerging. The efficacy is convincing considering the limited number of subjects in this study. The quantity of effect seems superior to that observed for currently available treatments. The tolerance of the treatment is excellent.”

Professor Alain Puech, Medical Director of KINNOV Therapeutics, lent support to this view. “KINNOV Therapeutics has been working for 10 years on the development of a new treatment with a unique and original mode of action. The simultaneous modification of two receptors (5HT2a and alpha1b) allows the patient to regain control of his/her consumption. “COCKTAIL”, a Phase II pilot trial aimed at providing clinical proof of this new therapeutic concept, clearly shows that KT-110 provides patients with a significant improvement in the parameters of alcohol addiction (alcohol consumption, number of heavy drinking days), with reduction figures higher than those reported existing treatments, in a context of good tolerance. The development of KT-110 will be pursued through phase III trials.

Emmanuel de Rivoire, Chief Executive Officer of Kinnov, said “The completion of the Phase II study with KT-110, our lead drug candidate, is a major milestone for KINNOV. Alcohol dependence, or AUD, is a serious public health issue and the medical need for the treatment of alcoholism is considerable and unmet: no new drug has been brought to market since 2013. Alcoholism is a crippling disease that is prohibitively expensive to treat and kills 3 million people every 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 now seeking a commercial pharmaceutical partner to continue the development and commercialization of KT-110; the promising results presented make us confident for the future.”

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

Founded in Orleans in 2015 Greenpharma (Philippe Bernard) and Key-Obs (Fabrice Trovero), Kinnov-Therapeutics is a biopharmaceutical start-up. The company is based on the work of JP Tassin and pre-clinical data generated the 2 founders between 2012 and 2015. The company has developed an innovative and novel mechanism of action based on the combination of two well known and approved molecules (cypropheptadine and prazosin) to fight against addictions regulating dopamine secretion. Kinnov has developed a first innovative drug candidate, KT-110, to fight alcohol dependence, which has just completed its phase II.

KINNOV Therapeutics is supported the Conseil Général Centre Val de Loire, the BPI and the European Union (Horizon 2020 program) and BIOCODEX.

Contact Details:

Emmanuel de Rivoire

[email protected]

+33 6 86 35 37 63

Dr. Bill Mason

The Sage Group

[email protected]

+44 77895 950134

Dr. Bill Mason
The Sage Group
+44 7785 950134
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