SAN DIEGO, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, announced that it will present poster presentations at ObesityWeek 2025, which is being held on November 4-7, 2025 in Atlanta, Georgia.
ObesityWeek Presentation Details:
Title: TAS2R Pan-Agonist ARD-101 Attenuates Weight Gain in Mice and Reduces Hunger in Adults with Obesity
Date and Time: Tuesday, November 4, 2025 at 7:30 p.m. - 8:30 p.m. ET
Presenter: Timothy Kieffer, Ph.D., Chief Scientific Officer of Aardvark
Title: An Isoflavonoid Modulator of Oxidative Metabolism with Therapeutic Potential in Obesity and Diabetes (WE-868)
Date and Time: Tuesday, November 4, 2025 at 7:30 p.m. - 8:30 p.m. ET
Presenter: Tien Lee, M.D., Chief Executive Officer of Aardvark
Aardvark to host investor webinar
Aardvark will be hosting an investor webinar on Wednesday, November 5, 2025 from 5:00 to 7:00 p.m. ET. Aardvark will provide an overview of ARD-101, ARD-201 and WE-868 data presented at ObesityWeek, feature a discussion with key opinion leaders in obesity drug development, and provide a discussion on ARD-101 in Prader-Willi Syndrome (PWS) with guests from Prader-Willi Syndrome Association - USA. The live webcast presentation will be accessible on the company’s website, www.aardvarktherapeutics.com, under the Investors tab, and an archived recording will be available on the website for approximately one month following the presentation.
About ARD-101
ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed in the intestinal lumen. As a potent bitter taste receptor pan-agonist, ARD-101 stimulates enteroendocrine cells of the digestive tract to release multiple gut-peptide hormones including GLP-1 and the satiety hormone cholecystokinin (CCK), which activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for PWS.
ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS.
About ARD-201
ARD-201 is an oral fixed dose combination of a dipeptidyl peptidase-4 (DPP-4) inhibitor and ARD-101. These receptors normally respond to nutrients and are part of the gut brain axis that helps regulate food intake. Activation of TAS2Rs stimulates the release of endogenous signaling molecules, including CCK and GLP-1, which play key roles in promoting satiety and reducing hunger. DPP-4 inhibitors, which are widely used for the treatment of diabetes, extend the biological activity of gut hormones, including GLP-1, by preventing their enzymatic inactivation. Together, these mechanisms allow ARD-201 to enhance and prolong the body’s natural signals for fullness.
Aardvark is advancing ARD-201 in two Phase 2 trials:
Expected to initiate in the second half of 2025, ARD-201 will be evaluated in the Phase 2 POWER trial for the potential to prevent weight regain in subjects who discontinue GLP-1RA therapy after achieving substantial prior weight loss (~15%).
Planned for initiation in the first half of 2026, ARD-201 will be evaluated in the Phase 2 STRENGTH trial for potential placebo-adjusted weight loss and the additive effects of ARD-201 combined with GLP-1RA therapy.
About WE-868
WE-868 is a novel, small molecule that modulates mitochondrial energy metabolism without directly suppressing the OXPHOS pathway. It is being evaluated in preclinical studies for the potential treatment of obesity and diabetes.
About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food). Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, and conducting two separate trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com.
Forward-Looking Statements
Statements in this communication about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning Aardvark’s upcoming presentations and webinar and the topics expected to be discussed in such presentations and webinar and the expected timing for commencement of its Phase 2 trials for ARD-201. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical and preclinical trials; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 that the Company filed with the Securities and Exchange Commission on August 13, 2025. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this communication are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.
Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Carolyn.hawley@inizioevoke.com
