Klaria announces first dose of its Sumatriptan Alginate Film (KL-00119)

Klaria Pharma Holding AB announced today that the first group of subjects received their first dose in the company’s pivotal Bioequivalence Study of Sumatriptan Alginate Film. The dosing of all 12 subjects in the first group took place on Tuesday, December 15[th].   

A total of 60 subjects will be dosed in the study.  The study has a cross-over design, where all subjects will receive both Sumatriptan Alginate Film as well as the comparator product.   The comparator product used in the study has been approved by both the European regulatory authority, EMA, as well as the US regulatory authority, the FDA.  This is in line with the advice provided to Klaria by both the EMA and the FDA in the advisory meetings that Klaria have completed in 2020.

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 8296159). 

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