KIEKIDS

Development of an innovative paediatric formulation of an antiepileptic agent for the treatment of absence epilepsy in children

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 Obiettivo del progetto (Objective)

'The KIEKIDS project is dedicated to the development of an innovative paediatric formulation of an antiepileptic agent for a safe alternative treatment of absence epilepsy in children.

Development of such an age-appropriate formulation is regarded by The European Medicines Agency (EMA) to be amongst one of highest priorities for the treatment of absence seizures, using a drug with identified and documented efficacy in the target population.

The KIEKIDS project has gathered a very strong consortium of well trained and qualified partners from industry, academy, and hospital with extensive experience in drug development in clinical, pharmacological, data analysis and regulatory areas. The proposed strategy for KIEKIDS implies to develop a dedicated paediatric formulation with sustained delivery and to conduct a clinical programme, which will be endorsed by approval of the Paediatric Investigation Plan (PIP).

The consortium is coordinated by the Unit 663 of INSERM (INSERM U663), a French public organisation of research devoted to the paediatric epilepsies and brain plasticity. This consortium rallies all the competencies required to manage a paediatric drug development from the designing of an adapted formulation up to market. With its solid track record of clinical success in pharmaceutical and biotech companies, and its huge expertise in absence epilepsy, this consortium will be able to avoid the pitfalls of pharmaceutical drug development and is in a strong position to guarantee the success of the programme.

The ultimate goal of KIEKIDS is to submit in 2015 this novel age-adapted paediatric formulation as a Paediatric-Use Marketing Authorisation, a PUMA, the tool identified by the EMA to bridge the gap for off-patent drugs.'

Introduzione (Teaser)

An efficient treatment for paediatric epilepsy is long overdue. European researchers are working on a safe drug formulation suitable for children.

Descrizione progetto (Article)

Childhood absence epilepsy manifests with unpredictable, unprovoked seizures that usually involve impairment of consciousness. This epilepsy could affect patient social behaviour, self-esteem and learning ability.

The EU-funded http://www.kiekids.eu/ (KIEKIDS) (Development of an innovative paediatric formulation of an antiepileptic agent for the treatment of absence epilepsy in children) project aims to develop an innovative paediatric drug for treating absence epilepsy in children. The focus is on an age-appropriate formulation of an anti-epileptic drug with identified and documented efficacy. To validate its efficacy and safety, the consortium will conduct a clinical programme, and apply for a Paediatric-Use Marketing Authorisation for this novel age-adapted paediatric formulation.

Researchers have developed and optimised various lipid-based formulations and their selection criteria were based on palatability, kinetics and feasibility of mass-scale synthesis. Stability data has already been obtained and production has been scaled up to the clinical level. The pharmacokinetic parameters of these formulations are under evaluation in a phase I study while a phase II trial will be performed in the next part of the project.

Polytherapy has hampered the effective treatment of young epileptic patients and is associated with adverse side effects. The pharmacokinetic and safety data will grant clinical implementation for the most suitable of these formulations.

Hundreds of thousands of children are affected by absence epilepsy who require prolonged treatment during childhood. An innovative anti-epileptic drug formulation could significantly improve the conditions of care for these patients.