HighTide Therapeutics, Inc. (Stock Code: 2511) released 52-week data from two Phase III clinical trials, SYMPHONY-1 and SYMPHONY-2, evaluating its new molecular entity HTD1801 in adult patients with type 2 diabetes mellitus (T2DM). The open-label extension phases of these trials demonstrated that the drug’s efficacy, observed over the initial 24-week double-blind period, was maintained through 52 weeks in both monotherapy and combination with Metformin.

In SYMPHONY-1 (N=408), HTD1801 monotherapy reduced glycated hemoglobin (HbA1c) from baseline by -1.3% at Week 24. Patients continuing HTD1801 maintained an average reduction of -1.2% at Week 52, while those initially on placebo achieved a similar reduction after switching to HTD1801. In SYMPHONY-2 (N=551), which evaluated HTD1801 in combination with Metformin, the initial -1.2% reduction of HbA1c was maintained at -1.1% by Week 52 for those remaining on HTD1801, with placebo-switched patients showing a comparable -1.2% decrease.

Additional long-term benefits at Week 52 included sustained improvements in cardiometabolic and renal endpoints, such as stable estimated glomerular filtration rate (eGFR) in the broader patient population, along with notable improvements in patients who entered with mild renal impairment. The overall safety and tolerability profile remained favorable, with no increase in the types or severity of adverse events upon extended treatment.

HighTide Therapeutics, Inc. plans to submit a new drug application for HTD1801 to the Center for Drug Evaluation of China’s National Medical Products Administration later this year. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares, as there is no guarantee that HTD1801 will ultimately be successfully marketed.