Klaria Announces Successful Outcome of Pivotal Bioequivalence Study with Sumatriptan Alginate Film
The bioequivalence study was conducted in the United Kingdom. The first subject was dosed in December 2020 and the last subject was dosed in March 2021. A total of 60 subjects were recruited into the randomized, 3-way cross-over study. A total of 59 subjects completed the study for Sumatriptan Alginate Film and 57 and 59 completed the study for the US and EU nasal spray comparator products, respectively. In addition to demonstrating bioequivalence, Klaria’s Sumatriptan Alginate Film demonstrated significantly lower inter-subject variability in the primary endpoints of the study. No serious adverse events were reported for any of the products involved in the study.
Dr. Scott Boyer, CSO of Klaria said “It is a great accomplishment for Klaria that we have successfully achieved the primary goal of the study: bioequivalence against two approved sumatriptan nasal spray products. Equally valuable is that we also demonstrated a successful result on the second most important goal of the study: reducing the inter-subject variability. For both patients and doctors, lower variability in the amount of sumatriptan absorbed from our Sumatriptan Alginate Films leads to greater certainty and confidence in the performance of the product during a migraine attack. Sumatriptan Alginate Film was designed to deliver sumatriptan precisely, rapidly and reliably. The data from this study has demonstrated that we have achieved exactly that.”
Jesper Wiklund, CEO of Klaria added “The positive results we announce today show for the first time that we can in fact execute our ambitious strategy: to create new products that are superior to nasal sprays/injections and meet significant unmet medical needs.”
About Klaria’s Sumatriptan Alginate Film (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 in patients suffering from migraine-induced nausea and vomiting. KL-00119 is also particularly suited for the treatment of migraine in pediatric populations. 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).