The Philippines FDA has granted approval for the Phase 3 clinical trial of YS Biopharma’s PIKA Rabies Vaccine
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The PIKA Rabies vaccination, utilizing YS Biopharma’s exclusive PIKA adjuvant technology, is a groundbreaking vaccine that enhances immunity and triggers a robust immune response. It has received orphan-drug designation (ODD) from the US FDA for both post-exposure prophylaxis (PEP) for rabies and rabies prevention. Unlike the current vaccine, which requires five visits over a month or three visits over three weeks, the PIKA Rabies Vaccine has the potential to revolutionize the treatment with a shorter three-visit one-week regimen. YS Biopharma has successfully completed Phase 1 and Phase 2 clinical studies of the vaccine in Singapore, and an additional Phase 1 trial was conducted in China to determine the optimal dosage and treatment plan. All three clinical studies have shown that the PIKA Rabies Vaccine is safe, well-tolerated, and highly effective.
The Phase 3 clinical trial for YS Biopharma’s PIKA rabies vaccine is scheduled to commence later in 2023 through a multi-centre, multi-country study. A total of 4,500 participants from the Philippines, Singapore, and Pakistan will be enrolled to evaluate the vaccine’s safety and immunogenicity. Upon the successful completion of Phase 3 trials, YS Biopharma plans to submit New Drug Applications or Biologics License Applications to the relevant regulatory authorities to facilitate the commercialization of the PIKA Rabies Vaccine.
Source: ysbiopharma.com
