ARD-101 / Aardvark Therap - LARVOL DELTA

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Aardvark Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Sep 2024

Trial completion • Trial completion date • Prader–Willi syndrome

Aardvark Therapeutics Reports Full Year 2024 Financial Results and Provides Business Highlights (GlobeNewswire) - "Initiation of the Phase 2 HONOR trial of ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025. Initiation of the Phase 2 EMPOWER trial of ARD-201 for the treatment of obesity and obesity-related conditions as a fixed-dose combination of ARD-101 with a dipeptidyl peptidase-4 (DPP-4) inhibitor is expected in the second half of 2025. Topline data from the Phase 3 HERO trial for the treatment of hyperphagia associated with PWS is expected in early 2026."

New P2 trial • P3 data: top line • Obesity • Prader–Willi syndrome

HERO: The Hunger Elimination or Reduction Objective Trial (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: Aardvark Therapeutics, Inc.

New P3 trial • Prader–Willi syndrome

Metabolic disease biotech Aardvark Therapeutics sets terms for $100 million IPO (Renaissance Capital) - "Aardvark Therapeutics, a Phase 3 biotech developing novel small molecule therapies for metabolic diseases, announced terms for its IPO on Thursday. The San Diego, CA-based company plans to raise $100 million by offering 5.9 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Aardvark Therapeutics would command a market cap of $363.5 million. Aardvark's wholly-owned lead candidate, ARD-101 (denatonium acetate monohydrate), is an oral gut-restricted small-molecule agonist of certain Bitter Taste Receptors (TAS2Rs) expressed in the gut lumen. The company has initiated a potentially pivotal Phase 3 trial of ARD-101 for hyperphagia associated with Prader-Willi Syndrome, with topline data expected in early 2026."

Financing • New P3 trial • P3 data • Prader–Willi syndrome

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: Aardvark Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Prader–Willi syndrome

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Jan 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Prader–Willi syndrome

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | N=12 ➔ 18

Enrollment change • Prader–Willi syndrome

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | Trial completion date: May 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Prader–Willi syndrome

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: Aardvark Therapeutics, Inc. | Active, not recruiting ➔ Completed

Bariatric surgery • Surgery • Trial completion • Genetic Disorders • Obesity

Study to Evaluate ARD-101 in Adults With Obesity (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Aardvark Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Nov 2022

Trial completion • Trial completion date • Genetic Disorders • Obesity

Study to Evaluate ARD-101 in Adults With Obesity (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Aardvark Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=30 ➔ 20 | Trial completion date: Dec 2022 ➔ Mar 2023

Enrollment change • Enrollment closed • Trial completion date • Genetic Disorders • Obesity

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Aardvark Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=30 ➔ 12

Bariatric surgery • Enrollment change • Enrollment closed • Surgery • Genetic Disorders • Obesity

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Sep 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Study to Evaluate ARD-101 in Adults With Obesity (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | Trial completion date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Jun 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Oct 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Prader–Willi syndrome

First-in-Human Evaluation of Oral Denatonium Acetate (ARD-101), a Potential Bitter Taste Receptor Agonist: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial in Healthy Adults. (PubMed, Clin Pharmacol Drug Dev) - "The phase 1 clinical results demonstrated safety of ARD-101 and indicated activation of gut peptide hormone release in healthy adults. Further clinical trials will evaluate ARD-101 in patients with metabolic and inflammatory disorders."

Clinical • Journal • P1 data • Genetic Disorders • Immunology • Inflammation • Obesity

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Aardvark Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Aardvark Therapeutics, Inc.

New P2 trial • Genetic Disorders • Obesity

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2; N=12; Recruiting; Sponsor: Aardvark Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Prader–Willi syndrome