ProteLight Pharma Received the Approval for its First Human Clinical Study in Australia for the Antimicrobial Peptide PL-18 Suppository


ProteLight Pharma announced that its PL-18 suppository, the Chinese national category I new drug, a novel antimicrobial peptide, has passed ethical review by the Australian Therapeutic Goods Administration (TGA), and will start its first human clinical study in Australia. This clinical study is a single-center, randomized, double-blind, dose-exploration Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of antimicrobial peptide PL-18 suppository in healthy adult female subjects with single-dose and multi-dose incremental dosing. PL-18 suppository is suitable for infection caused by bacteria and fungi, especially for stubborn infectious diseases caused by drug-resistant bacteria, and is intended to treat colpomycosis, bacterial vaginitis, and mixed vaginitis. About PL-18 Suppository as a novel broad-spectrum antimicrobial peptide drug, PL-18 Suppository is independently developed by ProteLight Pharma and has global intellectual property rights. The antimicrobial peptide PL-18 Suppository belongs to the non-antibiotic anti-infection peptide drugs, which has a unique antimicrobial mechanism of action and shows bactericidal advantages against Candida albicans, Staphylococcus aureus, Escherichia coli, Gardnerella vaginalis, and various antibiotic-resistant bacteria and fungi. 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. Female vaginal infection is a global social and public health problem with the characteristics of high incidence, high relapse rate, and wide epidemic size. Vaginitis is an inflammation or infection of the vagina, and the common reason is usually a change in the balance of the vaginal microenvironment caused by bacterial or fungal infections. According to SAI Research, the global market of vaginitis treatment drugs was US$5.1 billion in 2020, and it is highly expected to reach US$9.8 billion by 2030. It is growing at a commendable high compound annual growth rate CAGR of 6.7% between 2020 – 20301. About ProteLight Pharma Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. (ProteLight Pharma) is a high-tech biomedical enterprise focusing on the R&D of innovative antimicrobial and anti-cancer peptide drugs. The company is strengthening with a de novo design platform of α-helical AMPs and an innovative formulation platform of peptide drugs. It has formed a rich pipeline layout of innovative peptide drugs led by first-in-class anti-infective drugs and anti-cancer drugs, including various forms of peptide innovation preparations such as sprays, suppositories, inhalants, and injections. The company’s manufacturing base has set up the world's first peptide spray and peptide suppository production line and owns dozens of patents. Many projects have been supported by the national Mega-Projects for Innovative Drugs of China. The mission of ProteLight Pharma is to make efforts to break through the dilemma of antibiotic resistance and cancer all around the world, and to strive to develop new peptide drugs to meet major clinical needs, thus relieving the sufferings of patients with innovative drugs.