ARD-101 / Aardvark Therap - LARVOL DELTA

Updated Milestones (GlobeNewswire) - "Initiation of the Phase 2 HONOR trial evaluating ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025 with anticipated topline data readout in the second half of 2026."

New P2 trial • P2 data • Obesity

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