Pharmaceutical research and development company Sumitomo Pharma Co, Ltd and biopharmaceutical company POXEL SA (Euronext: POXEL) on Wednesday announced the results of a post-marketing clinical study of TWYMEEG (imeglimin hydrochloride) for treating type 2 diabetes in Japanese patients with renal impairment. The study, TWINKLE, found that the drug was safe and well-tolerated, with an adverse event profile consistent with prior studies.

TWYMEEG, a first-in-class agent targeting mitochondrial dysfunction in type 2 diabetes and marketed in Japan since September 2021. TWYMEEG works by promoting glucose-dependent insulin secretion and improving glucose metabolism in the liver and skeletal muscle. It was tested in an open-label, long-term study involving 60 patients with moderate to severe renal impairment or end-stage renal disease. Participants received either 500 mg of TWYMEEG twice daily or once daily, depending on their level of renal function, for 52 weeks. No significant differences were observed in adverse event incidence compared to previous studies, with most events being mild or moderate.

Sumitomo Pharma plans to discuss with Japanese regulatory authorities the potential revision of the drug's package insert in fiscal 2024 to include patients with an estimated glomerular filtration rate (eGFR) of less than 45 mL/min/1.73 m². Currently, TWYMEEG is not recommended for these patients.

Poxel, headquartered in Lyon, France, focuses on developing treatments for chronic diseases with metabolic pathophysiology. Its product pipeline includes therapies for non-alcoholic steatohepatitis and rare metabolic disorders.

Headquartered in Osaka, Japan, Sumitomo Pharma is committed to innovative research and development, focusing on areas such as psychiatry, neurology, and oncology.

The companies have a strategic partnership covering TWYMEEG's development and commercialisation in Japan, China and 11 other Asian countries.