Eurocine Vaccines´ nasal influenza vaccine candidate Immunose™ FLU showed good safety in older adults
Eurocine Vaccines today announced good safety and tolerability in older adults, in the second clinical phase I/II study including their quadrivalent influenza vaccine candidate. Immunose™ FLU is a novel nose drop formulation based on the company´s technology Endocine™ and inactivated split influenza antigens.
- I am very happy that we have once again confirmed good safety, this time in older adults, a population in need of better influenza vaccines. Now we look forward to the immunological results, which are expected in October, says Dr. Anna-Karin Maltais, CSO, Vice President R&D.
The study was conducted during the influenza season 2017/2018 with the purpose to evaluate safety and tolerability, as well as serological and mucosal immune responses to four influenza strains in older adults aged 50-75. A total of 298 subjects, with a mean age of 63 years, were divided into seven treatment groups and the study was conducted at five locations throughout Sweden. The compliance was high, with 99% of the subjects completing the clinical part of the study.
No serious adverse event was reported in the Immunose™ FLU groups. The reported adverse events were mostly mild or moderate. A tolerability evaluation measuring discomfort at the administration site showed mild and transient experiences, lasting less than two hours.
With this study, the safety database has expanded to a total of over 400 subjects for the platform technology Endocine™.
The data put us exactly where we want to be for our further development and in our hunt for the next vaccine project, says Dr. Hans Arwidsson, CEO.
For more details, please visit:
https://clinicaltrials.gov
This information is information that Eurocine Vaccines AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (no. 596/2014). The information was submitted for publication, through the agency of the contact person set out above, on August 8th, 2018.
Hans Arwidsson, Ph.D., MBA
CEO of Eurocine Vaccines AB
hans.arwidsson@eurocine-vaccines.com
+46 70 634 0171
Eurocine Vaccines is using its clinically validated technology Endocine™ to develop patent protected nasal vaccines. Endocine™, based on endogenous components, brings advantages such as creation of both mucosal and systemic immunity, as well as needle-free and convenient nasal vaccination.
The company´s first product candidate, the nasal quadrivalent influenza vaccine Immunose™ FLU, is currently in clinical phase I/II development, targeted to become the first approved nasal influenza vaccine for children under the age of 2 years. Within the market for influenza vaccines, children is the fastest growing segment. This is due to the recommendation by the WHO to vaccinate children against influenza.
A clinical study conducted with Immunose™ FLU in young adults in the season 2016/2017 showed good safety and immune responses in both nasal mucosa and in serum, which constitutes a good foundation for further development. The next clinical study was conducted during the influenza season 2017/2018 and included elderly subjects to generate necessary safety data. Concurrently, the elderly population will be evaluated as an additional business opportunity. Immunological results are expected in October 2018.
Eurocine Vaccines, EUCI, is traded at Spotlight Stock Market, XSAT.