Valneva is weeks away from releasing early data for its vaccine against chikungunya—an infection for which there are no approved shots—and now has jumped on the FDA's official fast track.
The designation is intended to help speed up review for products that would fill an unmet medical need. Valneva’s chief medical officer, Wolfgang Bender, said in a statement that the designation “will allow us to work closely with the FDA and to accelerate our efforts to develop a one-dose solution for the prevention of this spreading disease.”
Meanwhile, Valneva plans to release phase 1 data for its program in the coming weeks, the company said.
The French biotech trails Themis in chikungunya; the latter company has already pushed into midstage testing and is considering a phase 3 study.
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Chikungunya has been identified in dozens of countries, and there are currently no treatments or vaccines against the virus. The disease can cause debilitating joint pain and occurs mostly in Africa, according to the World Health Organization. It shares symptoms with Zika and dengue, often leading to misdiagnoses.
Outside of Themis and Valneva, PaxVax is also working on a chikungunya vaccine and earlier this year picked up an FDA fast track designation for its candidate. Bharat Biotech and Moderna also have candidates in early human testing.
As Valneva presses ahead in the disease area, the company recently pushed the only active Lyme disease candidate into phase 2; it's also working on vaccines against Zika and C. diff.