Aardvark Therapeutics reported that it has dosed its first patient in Australia for the HERO Phase 3 trial of its lead candidate, ARD‑101, a gut‑restricted small molecule designed to reduce hyperphagia in Prader‑Willi syndrome. The dosing, completed on December 10, 2025, marks the first Australian enrollment and expands the trial’s global footprint to include sites in Canada, the United Kingdom, and South Korea.
The company’s announcement highlighted that regulatory clearance has already been obtained in Canada and the United Kingdom, allowing the trial to proceed in those markets without additional approval delays. The Australian enrollment is part of a broader international expansion strategy that aims to enroll 90 patients across five countries, with a primary endpoint of change in the Hyperphagia Questionnaire for Clinical Trials (HQ‑CT) score at week 12.
Aardvark’s management emphasized the strong patient interest driving enrollment momentum. CEO Tien Lee noted that “we have seen very strong interest in the HERO trial within the patient community, which has been driving enrollment in the United States and in our newly opened Australia sites.” He added that all patients who completed the initial 12‑week trial have enrolled in the open‑label extension, underscoring sustained engagement.
The company reiterated its commitment to a third‑quarter 2026 topline data readout, a timeline that has remained unchanged since the trial’s initiation. Maintaining this schedule signals confidence in the trial’s operational execution and the robustness of the data collection plan.
Financially, Aardvark reported a cash balance of $126.4 million as of September 30, 2025, providing a runway that extends into 2027. The company’s cash‑rich position supports continued investment in the HERO program and other pipeline assets, such as ARD‑201, a combination therapy for obesity that has shown promising pre‑clinical weight‑loss signals.
Chief Medical Officer Dr. Manasi Jaiman highlighted the unmet need in the Prader‑Willi community, stating that “the eagerness for a therapy to ameliorate relentless hunger underscores the therapeutic potential of ARD‑101.” The company’s ARD‑101 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA, further supporting its development pathway.
The announcement was well received by the market, with trading volume on the day of the announcement 32 % above the 20‑day average, indicating heightened investor interest in the company’s clinical progress.
Overall, the first Australian dosing milestone represents a tangible step forward in Aardvark’s global clinical strategy, reinforces the company’s financial stability, and maintains the projected data readout timeline, all of which are material to investors’ assessment of the company’s future prospects.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.