ProteLight Pharma Innovative Drug Peceleganan Spray (Antimicrobial Peptide PL-5) Received FDA Approval for Phase II Clinical Trials in the United States


ProteLight Pharma announces the application of Peceleganan Spray (antimicrobial peptide PL-5) for Phase II clinical trial in the United States has been approved by the US Food and Health Administration (FDA). This clinical study is a multicenter, randomized, double-blind, dose-exploring Phase II clinical study to evaluate the efficacy and safety of Peceleganan Spray (antimicrobial peptide PL-5) in patients with mild and moderate diabetic foot ulcer infection. This product is currently undergoing a Phase III clinical trial in China and is indicated for secondary wound infection. It is intended to be used for burns, abrasions, scratches, lacerations, suture injuries, traumatic ulcers, pressure ulcers, venous ulcer infections and Wagner grade II diabetic foot ulcers and other wound infections. About Peceleganan Spray Peceleganan Spray (antimicrobial peptide PL-5), a new generation of broad-spectrum antimicrobial peptide drugs is independently developed by ProteLight Pharma with global intellectual property rights. It belongs to non-antibiotic anti-infection drugs. It has a novel mechanism of action and shows strong bactericidal advantages against Gram-positive bacteria, Gram-negative bacteria, and various antibiotic-resistant bacteria. This project was supported by the National “12th Five-Year Plan” and “13th Five-Year Plan” Mega-Projects for Innovative Drugs of China, and it is an internationally leading class of Ganan-type anti-infection drug. About Diabetic Foot Ulcer (DFU) DFU affects around 26 million people worldwide annually1. Every 20 seconds, somewhere in the world a patient loses a leg due to the complications of DFU2. DFU wound infection is the main cause of wound nonunion and amputation. Many DFU wounds eventually develop into chronic wounds infected by drug-resistant bacteria. Due to the lack of effective anti-infective drug therapy for bacteria, especially drug-resistant bacteria, 28% of DFU patients end up with lower limb amputation3. DFU causes significant patient suffering and socio-economic costs. About ProteLight Pharma Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. (ProteLight Pharma) is a high-tech biomedical enterprise focusing on the R&D of innovative antimicrobial and anticancer peptide drugs. The company is strengthening with a de novo design platform of α-helical AMPs and an innovative formulation platform of peptide drugs. It has formed a rich pipeline layout of innovative peptide drugs led by first-in-class antimicrobial drugs and anticancer drugs, including various forms of peptide innovation preparations such as sprays, suppositories, inhalants, and injections. The company’s manufacturing base has set up the world's first peptide spray and peptide suppository production lines and owns dozens of patents. Many projects have been supported by the national Mega-Projects for Innovative Drugs of China. The mission of ProteLight Pharma is to make efforts to break through the dilemma of antibiotic resistance and cancer all around the world, and to strive to develop new peptide drugs to meet major clinical needs, thus relieving the sufferings of patients with innovative drugs.
Phase III Clinical Trial of the Innovative Drug-Antimicrobial Peptide PL-5 Spray Was Launche