Klaria Pharmaceuticals updates timeline for announcement of data in pivotal bioequivalence trial of Sumatriptan Alginate Film
Klaria Pharmaceuticals announced today that the top-line data from its pivotal bioequivalence study of Sumatriptan Alginate Film will be available mid-May, 2021. The revised timing is due to factors related to the COVID-19 pandemic.
The approval of the study by the regulatory authority MHRA took place on November 30th, 2020. The first screening of subjects in the study took place on December 15th, 2020. This timing was a delay of approximately 1.5 months as compared to Klaria’s plan. The reason for the delay in the approval and study start was due to issues within the regulatory agency related to COVID-19. Subsequent efforts by Klaria to accelerate screening and dosing did not result in significant time savings, primarily due to the fact that extra protocols related to screening for COVID-19 had to be implemented.
Jesper Wiklund, CEO of Klaria stated “The revised timing for the study is due to reasons related to the Corona pandemic. As such, this is not a cause for concern on an operational study level and it will not have any negative financial consequences for Klaria.”
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).
For more information, visit the Klaria Pharma Holding website klaria.com or contact:
Jesper Wiklund, CEO Klaria Pharma Holding AB (publ)
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 (firstname.lastname@example.org, +46(0) 8-528 00 399) for Klaria Pharma Holding AB. For more information, see www.klaria.com.