On June 14, 2024, ProteLight Pharma was granted the Study May Proceed (SMP) letter by the U.S. FDA to commence human clinical trials for their innovative Antimicrobial Peptide PL-3301 Oral Gel. This significant approval marks the beginning of clinical development for this promising drug compound.

About the Antimicrobial Peptide PL-3301 Oral Gel:

The PL-3301, developed by ProteLight Pharma, is an innovative peptide drug with broad-spectrum antifungal and antibacterial properties. This novel peptide stands out for its innovative mechanisms and unique sequences. It is the product of de-novo design and autonomous research conducted by Chinese scientists, who possess exclusive worldwide rights and stakes in this advancement. The PL-3301 peptide exhibits characteristics such as unique formulation, low dosage, strong biological activities, high specificity, low toxicity, and satisfied efficacy. It directly targets oropharyngeal candidiasis infection sites, minimizing the potential of antibiotic resistance. ProteLight Pharma submitted this clinical application to drug authorities in China and the United States to explore its safety and effectiveness in clinical development. The drug aims to combat the increasing therapeutical needs for oropharyngeal candidiasis, alleviate the burden of disease, and provide an innovative solution to the antibiotic resistance and misuse. The mechanism of action of the antimicrobial peptide PL-3301 involves targeting the fungal membrane to induce disruption or rupture, ultimately leading to the death of the pathogen cell. In preclinical in vitro and in vivo tests, PL-3301 has shown remarkable efficacy in eliminating various oropharyngeal candida strains as well as antibiotic-resistant candida. If successful in clinical development, this drug compound will offer a new therapeutic option for the treatment of oropharyngeal candidiasis, contributing to advancements in medical practices. This project represents a first-in-class and first-in-concept drug developing, pioneering a new class of antifungal peptide for oropharyngeal fungal infections. 

About Oropharyngeal Candidiasis:

Candida is a prevalent element of the normal oropharyngeal microbiota, with around 30% to 50% of individuals hosting this microorganism. The prevalence of carriage tends to rise with age. White candida, which is commonly found in the oral and pharyngeal regions, is present in approximately 45% of newborns, 45%-65% of healthy children, 30%-45% of healthy adults, 50%-65% of denture wearers, 65%-88% of hospitalized and nursing home residents, 90% of acute leukemia patients undergoing chemotherapy, and 95% of individuals with HIV infection. The distribution of this microorganism is extensive. Candidiasis is considered an opportunistic infection. White candida colonizes the oral, esophageal, and gastrointestinal mucosa of healthy individuals, often leading to mucosal candidiasis. This condition is frequently observed in populations with compromised immune systems, such as newborns, the elderly, individuals with immunodeficiency disorders (like HIV/AIDS), and patients receiving prolonged systemic corticosteroids and antibiotics. In individuals with severe illnesses such as leukemia, lymphoma, or solid tumors, the prevalence of oropharyngeal candidiasis can exceed 32% due to immune suppression caused by corticosteroid or cytotoxic drug therapies. This ailment can result in swallowing difficulties and have a significant impact on the quality of life and overall health of affected patients.

Reference:

1. Patil S, Rao RS, Majumdar B, Anil S. Clinical Appearance of Oral Candida Infection and Therapeutic Strategies. Front Microbiol. 2015 Dec 17;6:1391. doi: 10.3389/fmicb.2015.01391. PMID: 26733948; PMCID: PMC4681845Taylor M, Brizuela M, Raja A. Oral Candidiasis. [Updated 2023 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545282/