On December 24, the official website of the Drug Evaluation Center (CDE) of the State Food and Drug Administration announced that the marketing application of Pratt&Lyle's Class 1 new drug Peceleganan Spray was accepted. In January 2023, CTTQ Pharma signed an exclusive commercial cooperation agreement with Pulei Pharmaceutical regarding the antimicrobial peptide product Peceleganan for the treatment of secondary wound infections in China.

Peceleganan (PL-5) spray is a new polypeptide broad-spectrum anti infective drug, which belongs to non antibiotic anti infective drugs and has a unique bactericidal mechanism. According to the pipeline information on the official website of ProteLight Pharma, the fastest indication for the research process of this product is secondary wound infection.

Secondary wound infection refers to open wound infection caused by various bacteria, including diabetes foot, bedsore, burn, etc. With the use of antibiotics, the proportion of drug-resistant bacteria is increasing, leading to the serious problem of pathogenic bacteria colonization. The continuous evolution of antibiotic resistance requires systematic antibacterial treatment, especially for local antibacterial treatment of infected sites.

According to the public information released by ProteLight Pharma, Peceleganan belongs to the application of the "cell membrane differentiation mechanism" theory. Based on the structure and composition of the cell membrane, a new antimicrobial peptide molecule was obtained using ProteLight Pharma's antimicrobial peptide development platform. It has a wide spectrum of antibacterial properties and has strong bactericidal advantages against various drug-resistant bacteria, including superbug MRSA (methicillin-resistant Staphylococcus aureus) and NDM-1 gene containing multidrug-resistant Acinetobacter baumannii.

In June this year, Network Open, a sub journal of the international medical journal Journal of the American Medical Association (JAMA), published the results of the Phase III clinical study of Jiangsu ProteLight Pharma’s Peceleganan spray. This Phase III randomized clinical study recruited and followed up 570 adult patients diagnosed with secondary open wound infection from 37 hospitals in China, and randomized them into two groups in a 2:1 ratio. They were treated with 2 ‰ Peceleganan spray (n=381) and 1% sulfadiazine silver (SSD) cream (n=189) respectively.

The proposed indication of this product is secondary wound infection. This study included patients with secondary infection caused by burns, physical injuries, ulcers or Wagner grade 2 diabetes foot ulcers and other reasons. The primary efficacy endpoint was the clinical effective rate on the first day after the end of the treatment (the eighth day after the first treatment). The clinical effective rate of the treatment group of Peceleganan spray was 90.4%, and the clinical effective rate of the positive control group was 78.7%. There was a significant statistical difference between the two groups (P<0.001), which realized the clinical efficacy research results of Peceleganan spray on the positive control drug.

Source: https://pharm.jgvogel.cn/c1476579.shtml