By Fineline Cube 
HighTide Therapeutics, Inc. (HKG: 2511) today announced that its two Phase III clinical trials, SYMPHONY‑1 (NCT06350890) and SYMPHONY‑2 (NCT06353347), have successfully completed, delivering robust efficacy and safety data for the first‑in‑class oral agent HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM).
Clinical Trial Highlights
| Study | Design | Population | Primary Endpoint | Key Findings (Week 52) |
|---|---|---|---|---|
| SYMPHONY‑1 | Randomized, double‑blind, placebo‑controlled | 408 adults with inadequate glycemic control after diet & exercise | Change in HbA1c at 24 weeks | Significant HbA1c reduction vs. placebo; durable benefit at 52 weeks |
| SYMPHONY‑2 | Randomized, double‑blind, placebo‑controlled | 551 adults with inadequate glycemic control after metformin | Change in HbA1c at 24 weeks | Significant HbA1c reduction vs. placebo; durable benefit at 52 weeks |
- Open‑label extension (28 weeks): All patients received HTD1801, confirming sustained efficacy and a favorable safety profile through 52 weeks.
- Safety: No new safety signals; adverse events comparable to placebo.
HTD1801 – A Dual‑Action Cardiorenal‑Metabolic Modulator
- Novel Mechanism – Activates AMPK while inhibiting the NLRP3 inflammasome, providing complementary anti‑inflammatory and metabolic benefits.
- First‑in‑Class – The only oral agent with a dual mechanism targeting both metabolic dysregulation and inflammasome‑driven inflammation in CKM disease space.
- Clinical Impact – Early Phase III data suggest HTD1801 could transform management of T2DM and reduce downstream cardiorenal complications.
Next Steps
- Regulatory Filing – HighTide will prepare a New Drug Application (NDA) for the U.S. FDA and a Marketing Authorization Application (MAA) for the EMA, leveraging the 52‑week dataset.
- Phase IV Planning – Post‑marketing studies will assess long‑term safety, cardiovascular outcomes, and real‑world effectiveness.
- Commercial Strategy – HighTide aims to position HTD1801 as a first‑line or add‑on therapy for T2DM, with potential expansion to other CKM indications.
Forward‑Looking Statements
This release includes forward‑looking statements that involve risks and uncertainties. Results may differ materially.-Fineline Info & Tech