Klaria reports last subject dosed in Sumtariptan Alginate Film study
Klaria reports that the last subject has been dosed in the pivotal Sumatriptan Alginate Film bioequivelance study. The first subject was dosed in December of 2020 and a total of approximately 60 individuals have been included in the study.
The current bioequivalence study of Klaria’s Sumatriptan Alginate Film (KL-00119) has concluded the ‘in life’ phase in which blood plasma levels of sumatriptan were assessed in study participants after taking either Klaria’s Sumatriptan Alginate Film or the chosen comparator products. In the coming weeks, detailed statistical analysis of the data will be performed and summarized.
We are pleased to announce the last patient dosed in this study and applaud our clinical research partner Simbec-Orion for their diligence under rather extraordinary circumstances. Rapidly implementing COVID screening strategies, getting those protocols approved by regulators and finalizing this study under the current pandemic is an achievement we can all be proud of. Dr. Scott Boyer, CSO.
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 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).
For more information, visit the Klaria Pharma Holding website klaria.com or contact:
Jesper Wiklund, CEO Klaria Pharma Holding AB (publ)
investor.relations@klaria.com
Tel: +46 (0) 8-446 42 99
This is Klaria Pharma Holding AB
Klaria (Klaria Pharma Holding AB) is a Swedish listed pharmaceutical company that develops innovative, rapid-acting products. By combining patented technology of a film that attaches to the oral mucosa and well proven pharmaceuticals, the company has developed a drug distribution concept with many benefits and potential uses. Klaria is listed on Nasdaq First North Growth Markets under the short name KLAR. FNCA Sweden is Certified Advisor (info@fnca.se, +46(0) 8-528 00 399) for Klaria Pharma Holding AB. For more information, see www.klaria.com.