Under a new partnering agreement with Themis Bioscience, the Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $21 million for the company’s phase 3-ready Chikungunya vaccine.
CEPI seeks to hasten regulatory approval of the vaccine by providing a large portion of the funds required for a phase 3 clinical trial. The hope is that applications will be submitted to regulatory authorities in the second half of the year, followed by trial initiation. Such trials will be conducted in both Europe and the Americas, benefiting from a U.S. Food and Drug Administration (FDA) fast track designation and the PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA). The phase 3 efforts are part of the larger CEPI-EU Framework Partnership agreement, which is developing vaccines to meet emerging infectious diseases.
“Our partnership with Themis represents an important step forward in the world’s efforts to address Chikungunya,” Richard Hatchett, CEO of CEPI, said. “Through our partnership, we look to accelerate the development of this vaccine candidate and to ensure that the people most affected by this virus can also benefit from this product.”
The World Health Organization (WHO) previous designated Chikungunya as a major public health risk. It has been afflicting nations throughout Africa and Asia since at least 1952, though its spread has picked up pace since 2004. In 2007, it crossed into Europe for the first time. The mosquito-spread virus is likely only to worsen as the effects of climate change solidify, and its victims suffer from fever, joint and muscle pains, headaches, nausea, fatigue, and rash.
The funds were possible with support from the European Union’s Horizon 2020 program. Past results from the completed phase 2 trial were published in The Lancet.