YS Biopharma Co. Ltd.’s PIKA rabies vaccine has been 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, is a multi-center, multi-country study designed to evaluate the safety and immunogenicity of the vaccine. The study will include approximately 4,500 people in the Philippines, Singapore, and Pakistan.
Pending the completion of phase 3 trials, YS Biopharma intends to submit New Drug Applications or Biologics License Applications to relevant regulatory authorities in order to commercialize the PIKA rabies vaccine. 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.
The PIKA rabies vaccine is a novel vaccine powered by YS Biopharma’s proprietary PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response.
About YS Biopharma’s PIKA rabies vaccine
It was granted orphan-drug designation (ODD) by the U.S. FDA for prevention of rabies infection including post-exposure prophylaxis (PEP) for rabies. 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 company has completed phase 1 and phase 2 clinical trials in Singapore. Another phase 1 trial was conducted in China to confirm the optimum dose and regimen to be used. All three clinical trials have shown that the PIKA rabies vaccine is safe, tolerable, and immunogenic. Recently, YS Biopharma also won approval to conduct phase 3 clinical trials of the vaccine in Singapore and Pakistan.
Rabies is a vaccine-preventable, zoonotic, viral disease affecting the central nervous system. It has a case-fatality rate of almost 100%, the highest among known infectious diseases, and there is currently no cure for rabies infection. According to the World Health Organization, an estimated 59,000 people die of 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 critical importance of developing a new generation of rabies vaccines that are capable of providing more effective and accelerated immune protection compared to the vaccines presently on the market.
Zenaida Mojares, chief medical officer of YS Biopharma, said: “Our recent approval to conduct phase 3 clinical trials of our PIKA rabies vaccine in the Philippines is a key step in advancing the clinical development of this life-saving vaccine. 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.”
Last year, Providence Therapeutics Holdings Inc. said its new mRNA vaccine program for rabies post-exposure prophylaxis achieved a preclinical proof-of-concept milestone. In a head-to-head immunogenicity comparison study with a commercial inactivated rabies vaccine, mice dosed with Providence’s pre-clinical rabies vaccine candidate produced higher levels of serum neutralizing antibodies than those of mice dosed with the comparator vaccine.