HighTide Therapeutics, a clinical-stage biopharmaceutical entity that focuses on the development of new therapies for the treatment of gastrointestinal diseases, chronic liver illnesses, and metabolic disorders, has announced that its lead candidate HTD1801 has gained approval by the Center for Drug Evaluation, National Medical Products Administration (NMPA) to facilitate clinical study in China.

For starters, HTD1801 is HighTide’s prominent drug candidate which is an ionic salt of ursodeoxycholic acid and berberine which is used to treat non-viral chronic liver disorders along with metabolic diseases. The candidate aims at enhancing blood glucose control in patients diagnosed with Type 2 Diabetes Mellitus (T2DM).

Sources claim that the recent grant will help accelerate the global development of HTD1801 along with the clinical progress in the treatment of T2DM, primarily T2DM comorbid with non-alcoholic fatty liver disorder across China.  

HTD1801 has already been awarded Fast Track designation by the U.S. FDA for NASH and PSC, coupled with Orphan Drug designation for PSC. The drug has also been included in China’s Major New Drug Innovation Program.    

According to Dr. Liping Liu, Founder and CEO, HighTide, the increasing incidences of metabolic diseases has led to complications like hyperlipidemia, hyperglycemia, obesity, and fatty liver. In HighTide’s latest Phase II clinical study in patients with non-alcoholic steatohepatitis comorbid along with T2DM in the U.S., HTD1801 has showcased considerable reduction in blood glucose, liver fat, serum lipids, liver enzymes, and body weight

Citing reports, T2DM has emerged as one of the leading health issues in the 21^st Century. China accounts for one of the largest T2DM patient pools across the globe, and the total number of patients is expected to rise rapidly.

Recent research data suggests that nearly 48.39% of the total Chinese adult population or 62 million people in China diagnosed with T2DM have non-alcoholic fatty liver disease.

Source Credit: https://www.businesswire.com/news/home/20210527005654/en/HighTide-Announces-NMPA-Approval-for-HTD1801-Clinical-Trial-in-China