Aardvark Therapeutics Expands Phase 3 HERO Trial Eligibility for ARD-101 in Prader-Willi Syndrome After FDA Protocol Alignment

Aardvark Therapeutics Inc. (NASDAQ:AARD) is one of the best young stocks with huge upside potential. On October 8, Aardvark Therapeutics announced that the company had reached alignment with the US FDA on a protocol amendment for its Phase 3 HERO trial. The trial is evaluating the company’s lead compound, ARD-101, for the treatment of hyperphagia (insatiable hunger) associated with Prader-Willi Syndrome/PWS, which is a rare disease.

The protocol amendment expands the eligibility of the patient population for the Phase 3 HERO trial by changing the minimum age for participation from 13 to 10 years old. The decision aligns with FDA guidance and was driven by support from the PWS community and historical data suggesting that younger patients may benefit more from early intervention.

ARD-101 is an oral, gut-restricted small molecule that acts as a potent pan-agonist of select bitter taste receptors/TAS2Rs expressed in the intestinal lumen. By stimulating enteroendocrine cells, it triggers the release of multiple gut-peptide hormones, including GLP-1 and the satiety hormone Cholecystokinin, which activates gut-brain neurological signaling to mediate hunger. ARD-101 has shown an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies.

Aardvark Therapeutics Inc. (NASDAQ:AARD) is a clinical-stage biopharmaceutical company that develops small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases.

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Disclosure: None. This article is originally published at Insider Monkey.