Novel Rabies Vaccine Candidate Receives Phase 3 Clinical Trial Approval

YS Biopharma Co., Ltd. today announced that its novel PIKA Rabies Vaccine was granted Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines.

The Phase 3 clinical trial, which is planned to commence later in 2023, will include approximately 4,500 subjects in the Philippines, Singapore, and Pakistan.

The PIKA Rabies Vaccine has the potential to become the first accelerated three-visit one-week regimen, superior to the currently available vaccine with a five-visit one-month or three-visit three-week regimen.

The US FDA granted orphan-drug designation for preventing rabies infection, including post-exposure prophylaxis (PEP) for rabies.

The PIKA Rabies Vaccine is powered by YS Biopharma's proprietary PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response.

Pending the successful completion of Phase 3 trials, the Company plans to launch the sales and marketing of the Vaccine in North America, as well as in countries throughout Asia, Africa, Europe, the Middle East, and Central and South America.

Rabies is a vaccine-preventable, zoonotic, viral disease affecting the central nervous system. It has a case-fatality rate of almost 100%.

According to the World Health Organization, about 59,000 people die of rabies annually in over 150 countries.

Over 30% of rabies victims are children.

The U.S. Centers for Disease Control and Prevention updated its recommendations for rabies preexposure prophylaxis for humans in June 2022, replacing the three-dose vaccination schedule with a two-dose program, intending to protect for about least three years.

As of June 1, 2023, there are various rabies vaccines approved.