This project has received funding from the
European Union’s Horizon 2020 research
and innovation programme under grant
agreement No 873252

Supported by:

Private investor

biocodex

Public funding

bpifrance europe region centre val de loire

PATIENT ORGANIZATION

vielibre

CURRENT SITUATION

Budget, acquired resources and needed funding

2019-2021 program, which consists in Phase II (POC) clinical trial in alcohol addiction, new O.D. formulation, toxicity confirmation study and go to market strategy program, is fully financed. New indication will require additional funding.

stats

market

In a regulatory point of view, the addiction was finally recognized as a real chronic pathology of the central nervous system in August, 2011 by the American Society for Addiction Medicine and validated by NIDA.

Addiction market estimations

  • 283 million people (237 men - 46 women) are affected by alcohol-dependence world wide.
  • 3,0 million deaths every year in the world are attributable to the alcohol abuse.
  • Healthcare costs: more than 5 % of the world load of the diseases and traumas.
  • Societal cost: more than 250 billions $ a year in the USA.
  • In France social cost : 120 bio for alcohol and 120 bio for tobacco.
  • Today anti addiction drug market 1.5 € bio (+20%/year).

BUSINESS STRATEGY

The strategy is to license out KT-110 to pharma company(ies) at the end of phase II.Example of deals closed in the addiction field:

Deal realized in 2011 in the field of the addiction

It concerns Biotie and Lundbeck companies for Selincro ( Nalmefene) at the end of 2011 in phase 2:

  • Upfront : 12 million euros
  • Milestones : 84 million euros
  • Royalties : not disclosed

Last realized deal (2013)

It concerns XenoPort companies and Reckitt Benckiser for Arbaclofen in phase 2:

  • Upfront : 25 million USD
  • Milestones : 70 million USD + 50 million USD
  • Royalties : not disclosed

Value at earlier stage (enter into Phase I) Indivior & Addex : AD71441 (2018)

  • Upfront : 5 million d'euros
  • Milestones : 330 million d'euros

KT-110 Timeline

General description

  • Status: Phase I/II
  • Indication: Alcohol addiction
  • Targets: 5-HT2 and alpha1-adrenergic receptors, which are central in the addiction processes. Indeed, they are involved in the activation of dopamine-producing neurons and in their action on the circuit of the reward. Their simultaneous inhibition allows to oppose the addicting effects of toxicomanogenous products by avoiding the side effects such as those produced by the antipsychotics.

Timeline

The next 2 years will be dedicated to the validation of the efficiency in humans of KT-110 with the indication « addiction to alcohol » and to the realization of an industrial partnership for a launch on the market on horizon 2020. The preclinical trials on other indications will be pursued. A trial of phase II on the tobacco will be prepared

statistique2-investors

KT-110 is a First in Class innovative pharmaceutical composition

The antagonists Drug1 and Drug2 entering the composition of KT-110 were strictly selected for their efficiency and on the basis of the following criteria:

Synergy and IP :

  • KT-110 composition is better than other drugs such as acomposate, naltrexone or nalmefene.
  • Patented protection of the composition

Safety:

  • Perfect knowledge of the components adverse effects
  • Drug2 alone was already tested clinically in addiction with interesting results