HighTide Therapeutics, Inc. (2511.HK) announced that HTD1801 met the primary endpoint in its Phase III HARMONY trial, a head-to-head study against dapagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin (N=369). The data showed a –1.12% LS mean reduction in HbA1c at Week 24 compared to –0.93% for dapagliflozin, representing a –0.20% difference (95% CI –0.37 to –0.03; P < 0.001). Gated secondary endpoints were also met, including superior improvements in LDL-C, non-HDL-C, and Lp(a), as well as a higher proportion of patients reaching HbA1c below 7.0%.

The safety and tolerability profile was favorable, with serious adverse events reported in 3.8% of the HTD1801 group versus 4.4% for dapagliflozin. Mild to moderate gastrointestinal events were the most common side effects, and no severe hypoglycemia occurred in the HTD1801 arm. According to the announcement, HARMONY is the third consecutive successful Phase III trial for HTD1801, following SYMPHONY-1 and SYMPHONY-2. HighTide Therapeutics intends to submit a New Drug Application for HTD1801 later this year.

The company cautioned that there is no guarantee HTD1801 will ultimately be successfully marketed. Shareholders and potential investors are therefore advised to exercise caution when dealing in the company’s shares.