Aardvark Therapeutics Reports Exploratory Data from the Terminated HERO and Open-Label Extension Trials
Aardvark Therapeutics reported exploratory data from the early-terminated Phase 3 HERO trial of ARD-101 in Prader-Willi syndrome, with 67 of 90 planned participants randomized. Efficacy signals were modest: HQ-CT scores fell by Week 2 on ARD-101, rebounded to near baseline after discontinuation (less rebound on placebo), and OLE participants switching from placebo to ARD-101 saw a further 6-point reduction by Day 28. Safety was generally acceptable, but one cardiac serious adverse event occurred at the 800 mg BID dose in a participant taking pitolisant, which FDA attributed to a drug-drug interaction.
Key figures
- Drug Name
- ARD-101
- Phase Of Trial
- Phase 3
- Sae dose
- 800 mg BID
- Pws clinical resume
- 2027
- Planned participants
- 90
- Randomized participants
- 67
- Hq ct reduction placebo to ard101 day28
- 6 points
AI analysis
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