Aardvark Therapeutics Inc. (NASDAQ:AARD) stock plunged on Friday after the release of exploratory efficacy data from its terminated Phase 3 HERO trial and open-label extension study.
The biopharmaceutical company unblinded the accumulated data to evaluate the safety and clinical profile of ARD-101 in patients with Prader-Willi syndrome.
Trial Results And Hunger Score Trends
The HERO trial randomized 67 of 90 planned participants before the company ended the study early.
During the second week of dose escalation, participants taking ARD-101 demonstrated a modest reduction in Hyperphagia Questionnaire for Clinical Trials scores versus placebo.
Hyperphagia is a condition that causes extreme hunger in people with Prader-Willi syndrome (PWS), a rare genetic disorder.
Hunger scores returned near baseline after patients stopped ARD-101, while the placebo cohort showed less rebound.
In the open-label extension cohort, participants who switched from placebo to ARD-101 achieved an average six-point reduction in hunger scores. Caregiver and clinician outcome ratings mirrored this trend.
“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,” said Tien Lee, Founder and CEO of Aardvark.
Safety Profile And Regulatory Next Steps
Patients generally tolerated ARD-101 well, reporting mostly mild to moderate adverse events.
The company identified one serious cardiac adverse event at the 800 mg twice-daily dose in a patient concurrently taking pitolisant, which the U.S. Food and Drug Administration attributed to a drug-drug interaction.
Aardvark plans to resume ARD-101 dosing in patients at a dose below 800 mg twice daily. The drugmaker also plans to request an FDA meeting to align its Phase 3 program and advance the therapeutic toward potential regulatory approval.
FDA Lifts Clinical Hold
On Thursday, the Food and Drug Administration (FDA) lifted the clinical hold on its Prader-Willi Syndrome (PWS) drug candidate, ARD-101.
In February, Aardvark Therapeutics voluntarily paused its Phase 3 HERO trial due to reversible cardiac observations at higher than target therapeutic doses found during routine safety monitoring.
In May, the FDA placed a full clinical hold on ARD-101, applying to all ongoing studies under the IND, including the Phase 3 HERO trial evaluating ARD-101 in patients with hyperphagia linked to Prader-Willi Syndrome, as well as the open-label extension study.
AARD Price Action: Aardvark Therapeutics shares were down 56.71% at $1.70 at the time of publication on Friday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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