Jiangsu Pleai Pharmaceutical Biotechnology Co., LTD. (" Pleai Pharmaceutical ") recently announced that its self-developed Class 1 innovative antimicrobial peptide PL-18 Supprant has received clinical approval from the Center for Drug Review and Evaluation (CDE) of the China National Medical Products Administration, and has passed the ethical review, and plans to start Phase I clinical trials in China in the near future.
The study is a single-center, randomized, double-blind, dose-increasing, placebo-controlled Phase I clinical study to evaluate the safety and tolerability of a single administration of the antimicrobial peptide PL-18 supposition in healthy adult female subjects. The drug is suitable for gynecological infections caused by bacteria and fungi, especially for stubborn infectious diseases caused by drug-resistant bacteria. It is intended to be used in the treatment of external negative candidiasis.
About the antimicrobial peptide PL-18 Suppository
As a first-in-class novel polypeptide broad-spectrum anti-infective drug, it is independently developed by Pu Lai Pharmaceutical and has global independent intellectual property rights. Antibacterial peptide PL-18 Supsupant belongs to the class of non-antibiotic anti-infection drugs, with unique anti-fungal and anti-bacterial action mechanism, and shows bactericidal advantages against Candida albicans, Staphylococcus aureus, Gardnerella and various antibiotic resistant bacteria. This project has been supported by the national "13th Five-Year Plan" major New drug development technology major special project, is the world's first polypeptide suppository variety. At present, this variety has been synchronously carried out phase I clinical studies in Australia.
About female genital tract infections
Female genital tract infection is caused by changes in vaginal microenvironment caused by bacterial or fungal infection and other factors. It is a global social and public health problem with high incidence, high recurrence rate and wide prevalence. According to SAI Research, the global market for female reproductive tract infections already reached US $5.1 billion in 2020 and is expected to reach US $9.8 billion in 2030, with a compound growth rate of 6.7% in 2020-2030.
