Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections

Background: Antimicrobial Peptide PL-5 (Peceleganan) Spray is a novel topical antimicrobial agent targeted on the treatment of skin wound infections. Methods: We conducted a multicenter, open-label, randomized, controlled phase IIb clinical trial to evaluate the efficacy and safety of PL-5 Spray, as compared with silver sulfadiazine, in patients with skin wound infections. The primary efficacy outcome was the clinical efficacy rate on the first day after ending the treatment (D8). The secondary efficacy outcome was the clinical efficacy rate on the fifth day post-treatment (D5), the bacteria clearance rate and the overall efficacy rate at the mentioned two timepoints. The safety outcomes included adverse reactions and pharmacokinetic analysis post-treatment. Findings: Between Jul 29, 2020, and May 10, 2021, a total of 220 patients from 27 hospitals in China were randomly assigned to 4 groups. On D8, the efficacy rate was 91·6%, 83·6%, 85·0% for the 1 ‰ PL-5, 2 ‰ PL-5, 4 ‰ PL-5 groups respectively, as compared with 60% for the control group. The efficacy rate between each PL-5 group and the control group was significantly different (P<0·05). On D5, the efficacy rate was 64·4%, 68·9%, 53·3% for the 1 ‰ PL-5, 2 ‰ PL-5, 4 ‰ PL-5 groups, respectively, as compared with 40·0% for the control group. The efficacy rate between each PL-5 group and the control group was significantly different (P<0·05). After the administration of 4 ‰ PL-5 on the wound, the blood concentration of PL-5 was not detectable in all patients of the pharmacokinetic group. No severe adverse event related to the application of PL-5 was reported among all participants of the study. Interpretation: Antimicrobial Peptide PL-5 Spray is safe and effective for the treatment of skin wound infections. Clinical Trial Registration Details: This study is registered through the Chinese Clinical Trial Registry Center (number: ChiCTR2000033334). Funding Information: Jiangsu Protelight Pharmaceutical & Biotechnology Co., Ltd. Declaration of Interests: Yating Wei, Jun Wu, Kunwu Fan, Xuming Yu, Xiaojian Li, Yaohua Zhao, Yi Li, Guozhong Lv, Guodong Song, Xinzhou Rong, Cai Lin, Haitao Wang, Xiaodong Chen, Pihong Zhang, Chunmao Han, Hongxu Zu, Wenjun Liu, Yi Zhang, Chang Liu, Yongtao Su, Baolin Zhang, Bingwei Sun, Lei Wang, Wen Lai, Jinhui Liu, Chengde Xia, Geng Ji, Feng Zhu, Jia’ao Yu and Akebaer·Ahemaiti have received grants from Jiangsu Protelight Pharmaceutical & Biotechnology Co·, Ltd. Yuxin Chen, Hu Dong, Mingxia Chen are employees of Jiangsu Protelight Pharmaceutical & Biotechnology Co., Ltd. Ethics Approval Statement: The study was designed and reported in accordance with The CONSORT statement,14 and conducted in accordance with the ethical principles of the Declaration of Helsinki,15 and the Good Clinical Practice guidelines of the International Council for Harmonisation.16 Ethical approvals from each independent ethics committee were obtained.