ProteLight Pharma’s Innovative Antimicrobial Peptide PL-18 Suppository Has Received FDA Approval to Commence Clinical Studies.
2024-10-26
On October 26, 2024, Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. ("ProteLight Pharma") received a Study May Proceed (SMP) letter from the FDA, indicating that the company's innovative Antimicrobial Peptide PL-18 Suppository has been approved for the Phase II clinical study in the United States.
The study is a multicenter, randomized, double-blind phase II clinical study to evaluate the safety and efficacy of multiple doses of the Antimicrobial Peptide PL-18 Suppositories in patients with Vulvovaginal Candidiasis (VVC). This trial builds on the completed Phase I studies conducted in Australia and China. Currently, the Phase II clinical trial in China is actively enrolling participants.
About Antimicrobial Peptide PL-18 Suppository
As a novel broad-spectrum anti-infective peptide drug, it has been independently developed by ProteLight Pharma, which holds complete intellectual property rights. The Antimicrobial Peptide (AMP) PL-18 Suppository represents a non-antibiotic approach to combating infections, featuring a distinctive antifungal and antibacterial mechanism of action. The AMP PL-18 Suppository demonstrates remarkable bactericidal efficacy against Candida albicans, Staphylococcus aureus, Gardnerella, and a range of antibiotic-resistant fungi and bacteria. This project has received support from the 13th Five-Year "Major New Drug Creation" science and technology initiatives, marking it as the world's first-in-class peptide suppository.
About Vulvovaginal Candidiasis
Vulvovaginal Candidiasis (VVC), formerly known as fungal vaginitis, is predominantly caused by the yeast Candida albicans. This condition is the most common infection of the reproductive tract among women of childbearing age, with over 70% of women experiencing it at least once in their lifetime. The clinical manifestations of VVC include vulvar itching, burning sensations, painful urination, and dyspareunia. Signs may include vulvar flushing, edema, and scratches or fissures. A white, membranous discharge may adhere to the inner labia minora and vaginal mucosa, and there may be an increased presence of a curd-like discharge within the vagina. Microscopic examination during laboratory analysis typically reveals the presence of budding spores, pseudo hyphae, lactobacilli, and inflammatory cells.
About ProteLight Pharma
Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. is a high-tech biomedical enterprise focusing on the R&D and manufacturing of peptide innovative drugs. The company has the world's leading de novo antimicrobial peptide drug design platform and peptide innovative preparation platform, and has a rich pipeline of drug products under development, including anti-infective, anti-tumor, autoimmune and metabolic multiple first-in-class innovative drugs and different forms of peptide innovative preparations such as sprays, suppositories, inhalers, and injections. The company's industrial base has the world's first peptide spray and peptide suppository production line. The company has dozens of invention patents, and many projects have been supported by the national "Major New Drug Creation" scientific and technological initiatives.
The company dedicates itself to developing innovative peptide and small molecule drugs that address critical clinical needs, ensuring more patients can access effective treatments that reduce the impact of various diseases.
References
- Denning DW, Matthew K, Sobel JD, et al. Global burden of recurrent vulvovaginal candidiasis: a systematic review[J]. The Lancet Infectious Diseases, 2018, 18（11）：e339-e347.
- Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23; 70(4):1-187. doi: 10.15585/mmwr.rr7004a1. PMID: 34292926; PMCID: PMC8344968.
