. 2020 Jul:114:104665.
doi: 10.1016/j.yrtph.2020.104665. Epub 2020 Apr 22.
Lijuan Sun 2 , FengLing Ren 3 , Ping Huang 4 , Zhuang Tian 4 , Jiazhen Cui 4 , Wangqian Zhang 1 , Shuning Wang 1 , Kuo Zhang 1 , Lei He 1 , Wei Zhang 1 , Cun Zhang 1 , Qiang Hao 1 , Yingqi Zhang 1 , Meng Li 5 , Weina Li 6
Affiliations
PMID: 32334036 DOI: 10.1016/j.yrtph.2020.104665
Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds
Chuanyang Xu et al. Regul Toxicol Pharmacol. 2020 Jul.
Abstract
BPC157 displays protective activity in various organs and tissues. This report presents preclinical toxicity studies with BPC157 in mice, rats, rabbits and dogs. The single-dose toxicity study did not show any test-related effects that could be attributed to the test article. In repeated-dose toxicity evaluations, BPC157 was well tolerated in dogs, with no abnormal changes between the BPC157-treated groups and the solvent control group, with the exception of a decrease in creatinine level at a dose of 2 mg/kg but not at lower doses. The animals recovered spontaneously after 2 weeks of withdrawal. This may be due to the pharmacological activity of BPC157. A local tolerance test showed that the irritation caused by BPC157 was mild. BPC157 also showed no genetic or embryo-fetal toxicity. In summary, BPC157 was well tolerated and did not cause any serious toxicity in mice, rats, rabbits and dogs. These preclinical safety data contribute to the initiation of an ongoing clinical study. Based on the stability and protective effect of BPC157, which has been widely reported, BPC157 may have a better application prospect than the widely used cytokine drugs in wound therapy.
Keywords: BPC157; Preclinical evaluation; Repeated-dose toxicity study; Safety; Single-dose toxicity study.
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Conflict of interest statement
Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.