Aardvark Therapeutics Reports Exploratory Data from the Terminated HERO and Open-Label Extension Trials
Key Highlights
- ➤HERO trial terminated early after 67 of 90 planned participants randomized.
- ➤ARD-101 produced modest HQ-CT reduction by Week 2 versus placebo.
- ➤Placebo-switching OLE participants saw an average 6-point HQ-CT reduction by Day 28.
- ➤FDA lifted ARD-101’s full clinical hold; Aardvark plans a new Phase 3 design meeting.
- ➤Aardvark plans to resume PWS clinical activities in 2027 at doses below 800 mg BID.
Expert Statements
Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark Therapeutics
“Though the HERO trial was stopped early and the current partial data are not sufficient to draw definitive conclusions, we believe these exploratory efficacy and safety data are directionally consistent and give us confidence in the continued development of ARD-101 for the treatment of PWS. We look forward to continuing to work closely with the FDA and plan to request a meeting to align on the design of a new Phase 3 trial intended to support a future marketing application, with the important goal of delivering this potential treatment option to patients in need.”
Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark Therapeutics
“Hyperphagia is one of the most challenging aspects of PWS for patients and their families, and we believe there remains a significant need for additional treatment options that can meaningfully reduce the constant, life-limiting hunger that defines this disease.”
* HERO trial terminated early (67 of 90 planned participants randomized); all efficacy data are considered exploratory * HQ-CT scores fell by Week 2 of dose escalation on ARD-101 and returned to near baseline within two weeks of stopping treatment, with less rebound on placebo * OLE participants switching from placebo to ARD-101 saw a further reduction in HQ-CT scores by Day 28 * ARD-101 was well tolerated; most adverse events mild to moderate * FDA lifted full clinical hold on ARD-101; Company plans to request FDA meeting to align on new Phase 3 trial design and expects to resume PWS clinical activities in 2027 * Conference call and webcast today at 8:00 a.m. ET SAN DIEGO, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi syndrome (PWS) and metabolic diseases, today reported exploratory efficacy data from its previously terminated Phase 3 Hunger Elimination or Reduction Objective (HERO) trial and open-label extension (OLE) trial. As previously announced, Aardvark unblinded the data accumulated across both the HERO trial and OLE trial to assess the totality of available efficacy and safety data to inform the path forward for ARD-101.
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