Antimicrobial Peptide PL-18 Suppository (First-in-class new drug) of ProteLight Pharma Received Clinical Trial Approval from CDE in China
Recently, Jiangsu ProteLight pharmaceutical & Biotechnology Co., Ltd. (abbreviated as: ProteLight Pharma) announced that the Antimicrobial Peptide PL-18 Suppository with independent intellectual property rights as first-in-class new drug has received Clinical trial approval from CDE in China and passed ethical review. Now, the project will launch Phase Ⅰ clinical study in China.
The objective of the single-center, randomized, double-blind, dose-increasing, placebo-controlled Phase Ⅰ clinical study is to evaluate the safety and tolerability of single-dose of the Antimicrobial Peptide PL-18 Suppository in healthy adult female subjects. The indication of the Antimicrobial Peptide PL-18 Suppository is intended for use in the treatment gynecological infections caused by bacteria and fungi, especially for stubborn infectious diseases caused by drug-resistant bacteria. The indication of the Antimicrobial Peptide PL-18 Suppository is also intended for use in the treatment vulvovaginal candidiasis.
About Antimicrobial Peptide PL-18 Suppository
Antimicrobial Peptide PL-18 is a novel first-in-class peptide drug with broad anti-infection spectrum. It is independently researched and developed by ProteLight Pharma who has global intellectual property rights. Antimicrobial Peptide PL-18 is a non-antibiotic drug with a unique antifungal and antibacterial mechanism of action, and shows bactericidal advantages against Candida albicans, Staphylococcus aureus, Gardnerella and antibiotics resistant bacteria. Antimicrobial Peptide PL-18 is an internationlly leading variety of peptide suppository. The project is supported by the national “13th Five-Year Plan” Mega-Projects for Innovative Drugs of China. At present, Phase Ⅰ clinical trial study of Antimicrobial Peptide PL-18 Suppository has been carried out in Australia simultaneously.
About Female genital tract infection
Female genital tract infection has the features of high incidence, high relapse rate, and wide epidemic size, which caused by bacterial or fungal infection and other factors that lead to changes in the vaginal microenvironment, and has been recognized as a global public health problem. According to SAI Research, the global market of female genital tract infection treatment drugs was US$5.1 billion in 2020, and it is expected to reach US$9.8 billion in 2030. The compound annual growth rate (CAGR) is 6.7% during 2020-20301.
About ProteLight Pharma
Jiangsu ProteLight pharmaceutical & Biotechnology Co., Ltd. is a high-tech biomedical company that specializes in developing and manufacturing novel peptide drugs. The company has international advanced de novo design platform and an innovative formulation platform of antimicrobial peptide drugs. The pipeline of drugs under development is rich, including multiple first-in-class varieties of innovative antimicrobial peptide drugs and anti-cancer drugs, as well as innovative peptide preparations in various forms such as sprays, suppositories, inhalants, injections, etc. The company’s manufacturing base has the world's first peptide spray and suppository production lines. The company owns dozens of patents and many projects have received support from the national Mega-Projects for Innovative Drugs of China.
ProteLight Pharma is dedicated to break through the dilemma of antibiotic resistance and cancer all around the world. The company will continuously strive to develop new peptide drugs to meet significant clinical needs and relieve the sufferings of patients with innovative drugs.