Themis announced today that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its most advanced program in development, a vaccine to prevent chikungunya fever. The PRIME scheme is designed to provide enhanced regulatory support for the development of medicines that target an unmet medical need. Chikungunya is a mosquito-transmitted disease that can have debilitating long-term effects and has no current treatment or prevention options. Themis' vaccine candidate has shown excellent safety and immune-response data in clinical testing to date. Final results of a large dose-confirmation Phase 2 trial are expected in mid-2018. Additional Phase 2 trials are underway, totaling over 600 study volunteers in the US, EU and Central America.
"Being accepted into the PRIME scheme recognizes the potential of our program and the important endeavor of preventing chikungunya, a severe disease with global outbreak potential and no available treatments," said Dr. Erich Tauber, CEO of Themis. "As we near the data read-out from our Phase 2 trial, we are currently gearing up for Phase 3 manufacturing and continuing interactions with the regulatory agencies will support a streamlined review and development process."
The PRIME initiative was launched by EMA in 2016 to facilitate the development of medicines that target an important unmet medical need and may offer a major therapeutic advantage or benefit to patients without treatment options. These medicines are considered priority medicines within the European Union (EU). PRIME offers enhanced support to medicine developers to strengthen clinical trial designs, facilitate the generation of high-quality data and enable accelerated assessment of medicine applications.