Recently, the independent research team from the School of Pharmacy at Nankai University achieved a significant milestone as their Class 1 innovative drug, CP0119 tablets, obtained the "Notice of Approval for Clinical Trial of Drugs" issued by the National Medical Products Administration. This approval allows for clinical trials targeting the treatment of slow transit constipation. This project marks Nankai University's second new drug project to receive clinical trial approval as the sponsoring institution, with the first new drug clinical trial approval granted back in 2017.
Epidemiological investigations reveal that the incidence of slow transit constipation in China ranges from 7.3% to 20.39%, and in recent years, there has been a steady upward trend in its incidence, significantly impacting patients' quality of life and compromising their physical and mental health. Moreover, it may lead to various serious complications. Current treatment methods mainly consist of basic therapy and medication. Basic therapy involves lifestyle adjustments and cognitive therapy, with medication being considered if basic therapy fails to show improvement after 4-8 weeks. However, existing treatment modalities have limitations, and the available options often fail to meet satisfactory outcomes. Therefore, treating slow transit constipation remains a challenging endeavor. Consequently, the development of an effective and low-toxicity therapeutic drug holds paramount importance.
CP0119, a Targeting Transgelin Therapy for Slow Transit Constipation: Mechanism Unveiled
CP0119, as elucidated by the project's principal investigator, stands as a novel small-molecule agonist of Transgelin, a member of the calponin family binding protein with a relative molecular weight of 22 kDa, predominantly found within smooth muscle cells. Acting as a stimulant on Transgelin within intestinal smooth muscle cells, CP0119 fosters the aggregation of G-actin to F-actin, thus bolstering the formation of stress fiber bundles within these cells. This enhancement culminates in amplified cellular contractility, facilitating intestinal peristalsis and ultimately ameliorating slow transit constipation. Notably, there are currently no similar medications targeting Transgelin for constipation on the market, rendering the development of CP0119 a groundbreaking endeavor in the realm of innovative drugs.
The project, spanning four years, encompassed scale-up synthesis of the active pharmaceutical ingredient, formulation development, systematic pharmacological and pharmacokinetic studies, as well as standardized preclinical GLP safety evaluations. These efforts have duly validated the controllability, safety, and efficacy of CP0119. Consequently, the development of CP0119 holds promise as a novel therapeutic option for patients suffering from slow transit constipation, promising substantial economic and societal benefits.
The research and development of CP0119 are spearheaded by the innovative drug development team from the School of Pharmaceutical Science and the State Key Laboratory of Medicinal Chemical Biology (SKLMCB) at Nankai University. It represents a significant collaboration with the China Medical Research and Development Center of CR Pharmaceuticals and the Tianjin International Biomedical Research Institute, emblematic of the collaborative efforts between academia, industry, and research institutions, epitomizing the synergy between academia and SKLMCB in joint ventures.
