The Food and Drug Administration (FDA) of the Philippines has given approval to biopharmaceutical firm YS Biopharma to begin a clinical trial of the PIKA rabies vaccine.
Scheduled to begin later this year, the multi-country, multi-centre Phase III study will evaluate the vaccine’s immunogenicity and safety.
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It will enrol nearly 4,500 patients across Singapore, Pakistan and the Philippines.
Following the study, YS Biopharma plans to submit new drug applications to regulatory authorities to commercialise the vaccine.
The PIKA vaccine is intended to be marketed in North America, Africa, Europe, the Middle East, Central America, South America and Asia.
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It is expected to become the first accelerated three-visit one-week regimen, as the only currently available vaccine has a five-visit one-month or three-visit three-week regimen.
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By GlobalDataYS Biopharma chief medical officer Dr Zenaida Mojares said: “Moving forward, our focus remains on generating robust clinical data that could demonstrate its clinical advantages and benefits as a new standard of care.
“The fight against rabies is far from over, and we will continue dedicating our innovation and expertise to this pivotal battle against a preventable tragedy.”
A Phase I trial of the PIKA Rabies Vaccine was conducted in China alongside Phase I and Phase II trials in Singapore.
In all three trials, the vaccine was found to be safe, tolerable and immunogenic.
YS Biopharma has also received approval to carry out Phase III clinical trials of the vaccine in Pakistan and Singapore.
Earlier this year, the company reported positive interim data from a Phase II/III trial of its PIKA recombinant Covid-19 vaccine.
The randomised, multi-centre study aimed to assess the immunogenicity, safety and efficacy of a booster dose of PIKA recombinant protein Covid-19 vaccine (CHO cell, S protein).
A total of 300 and 5,656 participants were enrolled in the Phase II and III trials respectively.
