Aardvark Therapeutics’ ARD-101 Study: A New Hope for Prader-Willi Syndrome

Aardvark Therapeutics, Inc. ((AARD)) announced an update on their ongoing clinical study.

Study Overview: The Hunger Elimination or Reduction Objective (HERO) Open-Label Extension Trial is a Phase 3 clinical study conducted by Aardvark Therapeutics, Inc. This study aims to assess the long-term safety and efficacy of ARD-101 in treating hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The study’s significance lies in its potential to improve the quality of life for individuals with PWS by addressing hyperphagia, a critical symptom of the condition.

Intervention/Treatment: The intervention being tested is ARD-101, an experimental drug administered in increasing doses over a 12-month period. The purpose of ARD-101 is to reduce hyperphagia symptoms in PWS patients, potentially offering a new therapeutic option for this challenging condition.

Study Design: This interventional study follows a single-group model with no masking, focusing on treatment as its primary purpose. Participants who completed a previous study will receive ARD-101 daily, with regular clinic visits and tele-visits to monitor progress and safety.

Study Timeline: The study began on September 21, 2025, with the primary completion and estimated completion dates yet to be announced. The last update was also submitted on September 21, 2025, indicating the study’s current recruiting status.

Market Implications: The ongoing study of ARD-101 could influence Aardvark Therapeutics’ stock performance positively if results demonstrate significant efficacy and safety. Investors may view this as a promising development in the treatment of PWS, potentially affecting market dynamics in the biopharmaceutical sector, particularly among companies focusing on rare genetic disorders.

The study is currently ongoing, with further details available on the ClinicalTrials portal.