1. AARD's first patient dosed in HERO trial in Australia. 2. Strong U.S. enrollment supports planned topline data readout in Q3 2026. 3. Regulatory clearances obtained for Canada and the UK trial sites. 4. All patients from initial trials engaged in Open Label Extension trial. 5. Significant unmet needs in the PWS community underscore therapy demand.
FAQ
Why Bullish?
Strong patient engagement and regulatory support augment AARD's trial outlook. Historical examples indicate that successful trial phases often boost biotech stock prices.
How important is it?
The article covers key update on clinical trial progress for AARD's lead asset, directly influencing stakeholder perceptions.
Why Long Term?
Topline data expected in Q3 2026 could significantly influence AARD's market position. Long-term impact emerges from proven clinical efficacy.
Aardvark Therapeutics Doses First Patient in Australia for HERO Phase 3 Trial
On December 10, 2025, Aardvark Therapeutics, Inc. (Nasdaq: AARD), a clinical-stage biopharmaceutical company, announced the successful dosing of the first patient in Australia as part of its pivotal Phase 3 HERO clinical trial. This trial assesses the efficacy of ARD-101 for treating hyperphagia in individuals suffering from Prader-Willi Syndrome (PWS), a rare metabolic disorder.
Key Developments in the HERO Trial
The HERO trial is gaining momentum with multiple active sites and robust enrollment in the United States, paving the way for a topline data readout anticipated in Q3 2026. Additionally, clinical trial sites in Canada and the United Kingdom have received regulatory clearance to begin enrolling participants.
- Strong enrollment continues in the US.
- First patient dosed in Australia in November 2025.
- Regulatory approvals secured in Canada and the UK.
- All patients who completed the trial have opted for an Open Label Extension.
Comments from Aardvark's Leadership
Dr. Tien Lee, Founder and CEO of Aardvark, expressed optimism regarding the ongoing trial. “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 stated. Furthermore, Dr. Manasi Jaiman, Chief Medical Officer, emphasized the significant unmet needs in the PWS community, highlighting the urgency for therapeutic solutions.
About the HERO Phase 3 Trial
The Hunger Elimination or Reduction Objective (HERO) trial (ClinicalTrials.gov Identifier: NCT06828861) is a randomized, double-blind, placebo-controlled study aimed at enrolling 90 patients across the US, Australia, Canada, the UK, and South Korea. Key endpoints include:
- **Primary:** Change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12.
- **Secondary:** Evaluation of caregiver impressions of severity related to hyperphagia and clinical global impressions.
Topline data is expected in the third quarter of 2026.
ARD-101: The Treatment Under Investigation
ARD-101 is a gut-restricted small molecule that acts as a potent agonist for specific taste receptors (TAS2Rs) present in the intestine. This medication stimulates the release of various gut-peptide hormones, such as GLP-1 and cholecystokinin (CCK), which play critical roles in hunger regulation. The FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for ARD-101 in the context of PWS.
About Aardvark Therapeutics
Aardvark Therapeutics, Inc. is focused on developing innovative, small-molecule therapeutics aimed at managing hunger and related metabolic diseases. The company’s lead candidate, ARD-101, is under Phase 3 clinical evaluation for treating hyperphagia associated with Prader-Willi Syndrome. Aardvark is also exploring ARD-201, a combination therapy designed to enhance outcomes for obesity-related conditions.
Forward-Looking Statements
This communication may contain forward-looking statements regarding Aardvark’s plans and expectations concerning its clinical trials and product candidates. Key risks could influence actual results, including clinical trial delays and the company’s resource management. Aardvark’s management disclaims any obligation to update forward-looking statements unless legally required.
Contact Information
For further inquiries, please contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Carolyn.hawley@inizioevoke.com