Aardvark Therapeutics: Exploratory Data Shows ARD-101 Efficacy; Clinical Hold Lifted
Aardvark Therapeutics, Inc. announced exploratory efficacy and safety data from its previously terminated Phase 3 HERO and open-label extension (OLE) trials for ARD-101. The data showed a modest reduction in HQ-CT scores by Week 2 of dose escalation, with scores returning to near baseline upon discontinuation. Participants switching from placebo to ARD-101 in the OLE trial experienced further reductions. ARD-101 was generally well tolerated, with most adverse events being mild to moderate. Importantly, the FDA has lifted the clinical hold on ARD-101, and the company plans to request a meeting to align on a new Phase 3 trial design, aiming to resume clinical activities in 2027. A single cardiac serious adverse event was noted and attributed to a drug-drug interaction.
Key Highlights
- Aardvark Therapeutics reports exploratory efficacy data from terminated Phase 3 HERO and OLE trials for ARD-101.
- HQ-CT scores fell by Week 2 of dose escalation on ARD-101 and returned to near baseline within two weeks of stopping treatment.
- OLE participants switching from placebo to ARD-101 saw a further reduction in HQ-CT scores by Day 28.
- ARD-101 was generally well tolerated; most adverse events were 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.
- Company expects to resume PWS clinical activities in 2027.
- One cardiac serious adverse event observed at 800 mg BID in HERO trial, concurred to be a drug-drug interaction with pitolisant.
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