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The game changer drug to cure alcohol use disorders

Periodic Reporting for period 3 - StopAddict (The game changer drug to cure alcohol use disorders)

Reporting period: 2021-09-01 to 2022-03-31

Alcohol Use Disorders (AUD) is a disease characterised by uncontrolled alcohol consumption. 283 million persons worldwide suffer from alcohol miss use which cause more than 3 million death and 132.6 million disability-adjusted life years.
Alcoholism has also huger damaging effects on families, communities and the overall society. Current drug therapies against AUD are unsuccessful due to low efficacy and poor tolerability. That situation leads to low patient recovery and only 10% of AUD people seeking for treatment.
In this context, KINNOV-THERAPEUTICS has developed a new revolutionary first-in-class drug allowing patients to control their alcohol consumption. KT-110 drug will highly impact the European burden of AUD by decreasing alcohol consumption on AUD patient by 70% leading to triple the number of AUD people seeking for treatment and save more than 5 million lives per year and several billion of social cost expenses. The efficacy of KT-110 is related to its action on a newly discovered pathway highly implicated in alcohol addiction. This major understanding of AUD addiction mechanism was granted the European College of Neuro Psychopharmacology award in April 2009.
After 10 years of intensive research and pre-clinical development, KT-110 has been accepted by the French regulatory agency for its first-in man phase II clinical trial by the end of 2018. This will be the main achievement of SMEi2020 project. Moreover all necessary actions for successful commercialisation to pharma companies (licensing deals) as well as continuous and updated IP & FTO issues are planned to be implemented during the SMEi2.
Through StopAddict project KT-110 will become the next leader of AUD treatment by generating 117€m of cumulative revenues between 2025-2027.
Our project will also allow to create more than 400 direct & indirect European jobs.
Today, the project is progressing. As many other organizations we suffered from the COVID 19 lock down which delayed our clinical trial by 6 months.
Patient recruitment is now completed and we expect results to be available by Feb 2022.
A new Once daily formulation will be ready in Q1/Q2 2022.
This report covers the first 12 months of the project.
In this period we achieved what was planned :
1- Start the phase II clinical trial (acronym COCKTAIL). We have included 30 patients at end of September. This is bellow expectation due to COVID-19 lock down which had a great impact on investigational centres. However a recovery plan in moving ahead.
2- Start the new One daily formulation for KT-110. We are confident that the technology chosen (double layer tablet) will allow to get the right formulation.
3- Reshuffle the website.
4- Commissioned a market potential and patient flow study ( with IQVIA) in 4 major countries (US, DE, UK, Russia) in order to validate commercial assumption and prepare the business case for licensing deals.
So far the project is progressing as planned.
However small delay can happen in clinical trial results due to slower recruitment than expected (due to COVID-19)
On the other hand all other assumptions on project impact and commercial potential are unchanged.
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