Klaria announces regulatory approval of the pivotal bioequivalence clinical study with Sumatriptan Alginate Film

Klaria has successfully completed regulatory review and has secured all necessary approvals to start the pivotal bioequivalence study with Sumatriptan Alginate Film.   The Medicines and Healthcare products Regulatory Agency (MHRA) have granted their approval of the study.  Klaria will now initiate the clinical study and the company reiterated the previously communicated timelines for the study, confirming that results are expected in Q1, 2021.  Additionally, review of the comprehensive EU development plan with the Swedish Medical Products Agency (acting as representative of the European Medicines Agency) has confirmed that the development plan of KL-00119 will be acceptable for market authorization in Europe.

The completion of the following items was announced today relating to the pivotal clinical trial for Sumatriptan Alginate Film (KL-00119):

  • Klaria has completed manufacturing of the clinical material of Sumatriptan Alginate Film 
  • Klaria has received approval from the UK Research Ethics Committee
  • Klaria has received approval of the Clinical Trial Application from the MHRA (the UK Competent Authority)

Additionally, Klaria has received positive Scientific Advice from the Swedish Medical Products Agency (acting as representative of the EMA) on the pivotal trial study design as well as the overall development plan up to market authorization in Europe.

Jesper Wiklund, CEO of Klaria said “We are happy to announce the approvals from the ethics committee and the MHRA and also the positive feedback from EMA on our development plan.  With these approvals in hand we will now start our pivotal bioequivalence clinical study.  Sumatriptan Alginate Film is our most advanced product.  With this announcement, we take an important step towards bringing this product closer to approval and the market.”

The review by the EMA covered the complete development plan of KL-00119, thereby confirming that the development plan currently executed by Klaria will be acceptable for market authorization in Europe. The review of the development plan covered clinical trial design and product manufacturing & controls as well as details relating to dose strengths, pediatric populations, product safety & toleration and product labelling.  The approval by the MHRA means that the clinical study can now proceed.

About KL-00119:  KL-00119 is an alginate-based oral trans-mucosal film.  KL-00119 is the first oral trans-mucosal migraine product and is designed to be a significant improvement to all available acute migraine treatments available to patients today, particularly to patients suffering from migraine-induced nausea and vomiting.  KL-00119 is a unique molecular dispersion of the active antimigraine drug sumatriptan.  The KL-00119 film presents sumatriptan to the oral mucosal surface in a unique way to allow rapid, consistent absorption with the lowest possible burden on the patient.  The base film-forming alginate and the sumatriptan-containing films have been the subject of comprehensive intellectual property protection, thus ensuring prolonged market exclusivity.  The uniqueness and promise of the KL-00119 has been confirmed by the project being awarded the exclusive European Commission Horizon 2020 Innovation Grant in 2018 (Grant Number 829615).

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