The publication of a confirmative Phase III clinical study on Peceleganan Spray (project code: PL-5), an innovative antimicrobial peptide developed by ProteLight Pharms, has been released.

2024-06-14


On June 11, 2024, the international renowned medical journal JAMA Network Open published the results of a large-scale Phase III clinical trial of Peceleganan spray, an innovative antimicrobial peptide developed by ProteLight Pharms, a company known for its expertise in developing cutting-edge antimicrobial/anti-cancer polypeptide.

 

This represents a significant milestone as the first successful Phase III clinical trial published in a prestigious international journal on an antimicrobial peptide drug developed to address wound infections. The trial, which meticulously monitored 570 adult patients diagnosed with secondary wound infections, was conducted across 37 hospitals in China. Patients meeting the criteria were randomly allocated in a 2:1 ratio to receive either treatment with 2% Peceleganan spray (n=381) or 1% silver sulfadiazine (SSD) cream (n=189). Peceleganan spray is specifically formulated for addressing secondary wound infections arising from burns, physical injuries, ulcers, or Wagner Grade 2 diabetic foot ulcers. The primary efficacy endpoint was the clinical efficacy rate on the first day post-treatment (day 8 after the initial treatment). The clinical efficacy rate of the Peceleganan spray treatment group was reached 90.4%, surpassing the positive control groups clinical efficacy rate 78.7%, with a statistically significant difference (P<0.001).

 

This study clearly demonstrated the clinical superiority of Peceleganan spray, a new therapeutic antimicrobial peptide spray, over the positive control medication. If Peceleganan spray successfully obtains market approval, it will provide patients suffering from secondary wound infections with a novel and effective treatment option. This advancement could significantly improve patient outcomes and quality of care in managing secondary wound infections.

References:

1.Wei Y, Li Y, Li X, et al. Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial. JAMA Netw. Open 2024; 7(6):e2415310. doi:10.1001/jamanetworkopen.2024.15310

2.Wei Y, Wu J, Chen Y, Fan K, Yu X, Li X, Zhao Y, et al. (2022). PL-5 Investigators. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. Ann. Surg. Jan 1; 277(1):43-49. doi: 10.1097/SLA.0000000000005508.