FDA places PaxVax's phase 2 chikungunya shot on its fast track

Working against a disease with no available vaccines, PaxVax has picked up an important regulatory boost from the FDA for its chikungunya shot. The agency blessed the candidate with its Fast Track Designation, meaning extra regulatory assistance on a path toward a possible approval. 

The designation grants drug and vaccine developers perks including more frequent meetings and written communications with agency personnel, eligibility for accelerated approval and priority review, plus the ability to submit portions of their applications at a time rather than all at once, according to the FDA. 

PaxVax licensed its chikungunya candidate from the NIH early last year, adding to its pipeline of shots against HIV, Zika and more. The company also markets cholera and typhoid vaccines. 

Just last month, the biotech started enrolling 400 participants as part of a phase 2b study to identify the correct dose. The study seeks to build on a previous phase 2a study conducted by the NIH. PaxVax is expecting results for the latest test in early 2019. 

The company's chikungunya shot is based on viruslike particle technology, which mimics the natural structure of viruses but lacks the viral genome. 

Elsewhere, Themis, Bharat Biotech and Moderna all have chikungunya vaccine candidates in the works. Themis' program is in phase 2, while the other two companies started initial human studies last year.  

A viral infection, chikungunya can cause debilitating joint pain, according to the World Health Organization, and occurs mostly in Africa. It shares symptoms with Zika and dengue, often leading to misdiagnoses. The name comes from a word in the Kimakonde language that means "to become contorted," according to the international agency, as victims experience severe joint pain and stoop over.  

Other outbreaks have happened in Asia, Europe and in the Indian and Pacific oceans, according to the CDC. An outbreak in 2015 made it to the Americas. 

Register as Visitor to CPhI China 2018!