Tides Express | Pratt&Lyle polypeptide drug PL-3301 oral gel approved by FDA

Edited by the Peptide Biochemical Content Team
On June 14, 2024, Pratt&Lyle Pharmaceuticals received the official reply from the US FDA that approved its new class 1 drug, antibacterial peptide PL-3301 oral gel, to conduct human clinical research and verification.About Antimicrobial Peptide PL-3301 Oral gel
As a first in class peptide broad-spectrum antifungal and bacterial infection drug originally created in China, it was independently designed and developed by Pratt&Whitney Pharmaceuticals from scratch, with independent global intellectual property rights and rights. Antibacterial peptide PL-3301 has innovative mechanisms and peptide sequences. Its development characteristics include unique dosage form, low dosage, strong biological activity, high specificity, low toxicity, and significant therapeutic effect. It directly acts on the site of oral candidiasis infection and is not prone to drug resistance. The Prai Pharmaceuticals program will submit this clinical research project to relevant pharmaceutical regulatory authorities in China and the United States to explore its safety and effectiveness in clinical applications, meet the growing clinical treatment needs of oral and pharyngeal candidiasis, reduce the disease burden on patients, and provide innovative solutions to the risks of antibiotic resistance and abuse.
The mechanism of action of antimicrobial peptide PL-3301 is to kill fungi by targeting their cytoplasmic membranes, causing them to lose membrane integrity or rupture, leading to fungal cell death. The antimicrobial peptide PL-3301 has efficient bactericidal advantages against various oral Candida and antibiotic resistant Candida. Its antibacterial activity has been effectively demonstrated in preclinical in vitro experiments and animal models. If successful in clinical development, this product will provide a new option for the treatment of oropharyngeal candidiasis and current medical practice. This project belongs to first in class and first in concept drugs, and is the first antimicrobial peptide drug in China to resist oral fungal infections.
About Candida
Candida is one of the components of the normal oral microbiota, and approximately 30% to 50% of people carry this microorganism. The carrying rate increases with the age of the patient. It is reported that the incidence rate of candida albicans isolated from the oropharynx is 45% in newborns, 45% -65% in healthy children, 30% -45% in healthy adults, 50% -65% in people wearing dentures, 65% -88% in people hospitalized and nursing institutions, 90% in patients with acute leukemia receiving chemotherapy, and 95% in people infected with HIV. Its population is widely distributed.
Candidiasis is an opportunistic infectious disease. Candida albicans colonizes the oral, esophageal, and gastrointestinal mucosa of healthy individuals, and can cause mucosal candidiasis in these areas. This disease typically exists in populations with immune dysfunction and immunosuppression, including newborns and the elderly, immunocompromised diseases (such as HIV/AIDS), and patients with long-term systemic use of steroids and antibiotics. In the treatment of patients with leukemia, lymphoma, solid tumor and other serious diseases, due to the use of corticosteroids or cytotoxic drugs, their immunity is damaged, and the incidence rate of oral candidiasis is more than 32%, which leads to dysphagia and will seriously affect the life and quality of life of patients.
About Pulai Pharmaceuticals
Pulai Pharmaceutical is a high-tech biopharmaceutical enterprise mainly engaged in the research and production of innovative peptide drugs. The company has an internationally leading platform for the de novo design of antimicrobial peptide drugs and a platform for innovative peptide preparations. The pipeline layout of drug products under research is rich, including multiple first in class varieties of antimicrobial peptides and anti-tumor peptides, as well as different forms of innovative peptide preparations such as sprays, suppositories, gel, inhalants, and injections. The company’s industrial base is equipped with the world’s leading production line of polypeptide spray and polypeptide suppository, has dozens of invention patents, and many projects have won the national “major new drug creation” science and technology major special support.