Aardvark Therapeutics releases exploratory HERO and OLE trial data for ARD-101
Aardvark Therapeutics reported exploratory efficacy and safety data from its previously terminated Phase 3 HERO trial and open-label extension, which the company says are directionally consistent with continued development of ARD-101 for Prader-Willi syndrome. The company states the partial data are not sufficient to draw definitive conclusions, the HERO trial was stopped early, and the FDA has lifted the clinical hold, so the company plans to request an FDA meeting on a new Phase 3 design.
Key points
- HERO trial was terminated early with 67 of 90 planned participants randomized; all efficacy data are considered exploratory
- OLE participants who switched from placebo to ARD-101 had an observed average 6-point reduction in HQ-CT score
- One Grade 4 cardiac serious adverse event occurred at 800 mg twice daily with pitolisant, which the FDA concurred is related to a drug-drug interaction
- FDA lifted the clinical hold on October 22, 2026; the company expects to resume PWS clinical activities in 2027
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 23, 2026.
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