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China based The United Laboratories International Holdings Limited (TUL) and Danish pharmaceutical company Novo Nordisk A/S have announced that Novo Nordisk and TUL's wholly-owned subsidiary The United Bio-Technology (Hengqin) Co. have entered into an exclusive license agreement for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early-stage clinical development for the treatment of obesity, type 2 diabetes, and other diseases.
Under the license agreement, Novo Nordisk will obtain exclusive worldwide rights (excluding Chinese mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize UBT251. United Biotechnology will retain the rights for UBT251 in Chinese mainland, Hong Kong, Macau, and Taiwan. United Biotechnology is eligible to receive an upfront payment of $200 million and potential milestone payments of up to $1.8 billion dollars from Novo Nordisk, as well as tiered royalties on net sales outside of Chinese mainland, Hong Kong, Macau, and Taiwan.
United Biotechnology recently completed a randomised, double-blind, placebo-controlled phase 1b trial in China designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of UBT251 in people with overweight or obesity.
A total of 36 patients were enrolled in three different dose groups (1mg, 1mg/3mg, 1mg/3mg/6mg). Each group adopted a dose titration method, with subcutaneous injection once a week for 12 consecutive weeks.
The safety profile of UBT251 was consistent with incretin-based therapies. The most common adverse events were gastrointestinal and the vast majority were mild to moderate in severity. In the highest dose group, the average weight of the people who completed the trial decreased by 15.1% from baseline, while the average weight of people in the placebo group increased by 1.5% from baseline.
