Aardvark Therapeutics Reveals Promising Weight Loss Data for ARD-201

Aardvark Therapeutics Showcases ARD-201's Efficacy in Obesity Treatment

Aardvark Therapeutics, Inc. (Aardvark) (NASDAQ: AARD) has unveiled new preclinical data that highlights the promising results of their innovative treatment ARD-201 in addressing obesity and related metabolic disorders. The recent findings stem from rigorous testing conducted in validated diet-induced obesity (DIO) mouse models, renowned for their relevance in studying glucagon-like peptide-1 receptor agonists (GLP-1RAs). Over the course of a 30-day treatment period, the study demonstrated an impressive reduction of approximately 19% in body weight among subjects.

ARD-201's Unique Approach to Weight Management

The studies reveal that ARD-201 not only includes mechanisms to encourage weight loss but also aids in preventing weight regain after the discontinuation of GLP-1RA treatments like tirzepatide. Moreover, when used in conjunction with low-dose tirzepatide, ARD-201 enhanced the effects of weight loss seen with tirzepatide alone. These findings suggest that ARD-201 has significant potential as a monotherapy and in combination with established weight-loss medications.

Understanding ARD-201

ARD-201 is formulated as an oral fixed-dose combination, incorporating both a dipeptidyl peptidase-4 (DPP-4) inhibitor and ARD-101, a small molecule that activates specific taste receptors located in the gut. This activation is essential for the regulation of food intake and appetite, addressing the dual challenges of obesity and associated metabolic conditions. By stimulating the release of crucial endogenous signaling molecules such as cholecystokinin (CCK) and GLP-1, ARD-201 optimizes the body’s hunger signals and promotes feelings of fullness.

Future Clinical Trials for ARD-201

As a response to the promising preclinical insights, Aardvark is gearing up to initiate two major Phase 2 clinical trials centered around ARD-201. The first, titled the Phase 2 POWER trial, aims to investigate ARD-201’s role in preventing weight regain in those who have previously lost considerable weight with GLP-1RA therapies. This trial is expected to commence in the latter half of the year, encompassing a 24-week program with interim evaluations at 12 weeks to assess initial outcomes.

The second trial, the Phase 2 STRENGTH trial, is set to begin in the first half of the following year. This pivotal study will evaluate weight loss achieved through ARD-201 treatment, both as a standalone therapy and in conjunction with GLP-1RA treatments. Crucial secondary objectives will delve into aspects like the quality of weight loss, particularly focusing on the balance between fat reduction and lean muscle preservation.

Expert Opinions Highlight the Potential of ARD-201

Timothy Kieffer, Ph.D., Chief Scientific Officer at Aardvark, expressed enthusiasm about ARD-201’s ability to assist patients transitioning away from GLP-1RA therapies while still achieving meaningful weight loss. He emphasized its oral administration, making it a more accessible option compared to injectable therapies. Randy J. Seeley, a professor specializing in surgery, noted the innovative mechanism behind ARD-201, suggesting it could revolutionize the obesity treatment landscape.

About Aardvark Therapeutics, Inc.

Aardvark Therapeutics pursues the development of novel small-molecule therapies aimed at addressing hunger and metabolic disorders. With a focus on understanding the distinct neural pathways associated with hunger and appetite, Aardvark is determined to enhance therapeutic applications in these areas. Their lead compound, ARD-101, is currently in Phase 3 clinical development, targeting hyperphagia relating to Prader-Willi Syndrome (PWS). Furthermore, Aardvark continues to advance its efforts with ARD-201, aspiring to tackle the limitations seen in current GLP-1RA treatments.

To learn more about Aardvark Therapeutics and their ongoing projects, interested parties can visit their website at aardvarktherapeutics.com.

Frequently Asked Questions

What is ARD-201, and how does it work?

ARD-201 is an oral treatment that combines a DPP-4 inhibitor with a small molecule. It aims to enhance weight loss by regulating hunger signals and promoting fullness.

What results were observed in the preclinical studies for ARD-201?

The studies indicated a 19% body weight reduction over 30 days and demonstrated its effectiveness in preventing weight regain after stopping GLP-1RA therapies.

When will clinical trials for ARD-201 begin?

The Phase 2 POWER trial is expected to start in the second half of the year, while the STRENGTH trial is planned for the first half of the following year.

How does ARD-201 compare to existing GLP-1RA therapies?

ARD-201 offers an innovative oral option that not only aids weight loss but also helps maintain weight after therapy, potentially offering improved tolerability than injectables.

What diseases does Aardvark Therapeutics focus on?

Aardvark focuses on developing treatments for hunger-related conditions and metabolic diseases, including significant efforts towards addressing obesity and hyperphagia associated with Prader-Willi Syndrome.

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