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Aardvark Therapeutics says the information about its Prader-Willi Syndrome drug isn't enough.

TrialRead the original at Benzinga
Bad for AARD

An extension group saw hunger scores fall by 6 points, and the FDA lifted the hold for a lower-dose restart. Still, the main trial ended early, its modest benefit faded after treatment stopped, and a serious heart event tied to a drug interaction leaves the treatment's value unproven.

AARD · Aardvark Therapeutics Inc.

AI read · Bad for AARD

The AI's read

This leaves Aardvark without clear proof that ARD-101 can reduce severe hunger for long enough to help patients. Some patients who switched from placebo had lower hunger scores, and most side effects were mild or moderate. But the main trial stopped early, scores returned close to their starting point after treatment ended, and one serious heart event occurred at the high dose. The FDA linked that event to another medicine and lifted the hold. A lower-dose restart is planned, but the trial still has not shown a lasting benefit.

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