PIKA YS rabies vaccine Biopharma Co. Ltd. has obtained phase 3 clinical trial approval from the Food and Drug Administration of the Philippines.
The phase 3 clinical trial, planned to start in 2023, is a multi-centre, multi-country study designed to evaluate vaccine safety and immunogenicity. The study will involve around 4,500 people in the Philippines, Singapore and Pakistan.
While waiting for the completion of phase 3 trials, YS Biopharma intends to submit a New Drug Application or Biological License Application to the relevant authorities to commercialize the PIKA rabies vaccine. The company plans to launch sales and marketing of the vaccine in North America, as well as in countries across Asia, Africa, Europe, the Middle East, and Central and South America.
The PIKA rabies vaccine is a new vaccine powered by YS Biopharma’s PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response.
About the PIKA rabies vaccine from YS Biopharma
It was given the orphan drug designation (ODD) by the US FDA for the prevention of rabies infection including post-exposure prophylaxis (PEP) for rabies. The PIKA rabies vaccine has the potential to be an accelerated first three-visit one-week regimen, superior to currently available vaccines with five-visit one-month or three-visit three-week regimens.
The company has completed phase 1 and phase 2 clinical trials in Singapore. Another phase 1 trial is being conducted in China to ascertain the optimal dosage and regimen to be used. These three clinical trials demonstrated that the PIKA rabies vaccine is safe, tolerable, and immunogenic. Recently, YS Biopharma also received approval to conduct phase 3 clinical trials of the vaccine in Singapore and Pakistan.
Rabies is a vaccine-preventable zoonotic viral disease that affects the central nervous system. It has a case fatality rate of nearly 100%, the highest of any known infectious disease, and there is currently no cure for rabies infection. According to the World Health Organization, an estimated 59,000 people die from rabies annually in more than 150 countries, with 95% of cases occurring in Asia and Africa.
More than 30% of rabies victims are children, and the disease remains a significant challenge to the global public health system. The devastating nature of the disease underscores the importance of developing a new generation of rabies vaccines that are able to provide more effective and accelerated immune protection compared to vaccines currently on the market.
Zenaida Mojares, chief medical officer of YS Biopharma, said: “Our recent approval to conduct a phase 3 clinical trial of our PIKA rabies vaccine in the Philippines is an important step in advancing the clinical development of this life-saving vaccine. Going forward, our focus remains on generating robust clinical data that can demonstrate their clinical superiority and benefit as a new standard of care. The fight against rabies is far from over, and we will continue to dedicate our innovation and expertise to this important battle against this preventable tragedy.”
Last year, Providence Therapeutics Holdings Inc. said its new mRNA vaccine program for post-exposure prophylaxis of rabies reached a preclinical proof-of-concept milestone. In a head-to-head comparative immunogenicity study with inactivated commercial rabies vaccine, mice given Providence’s pre-clinical rabies vaccine produced higher serum levels of neutralizing antibodies than mice given the comparator vaccine.