Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome
Aardvark Therapeutics (Nasdaq: AARD) announced FDA alignment on a protocol amendment to its Phase 3 HERO trial of ARD-101 for hyperphagia in Prader-Willi syndrome (PWS).
The amendment lowers minimum enrollment age from 13 to 10 years, broadening the eligible patient population. Management cited community support and historical data suggesting younger patients may benefit more from early intervention. The company reaffirmed a planned topline data readout in Q3 2026.
Aardvark Therapeutics (Nasdaq: AARD) ha annunciato l'allineamento da parte della FDA su un emendamento al protocollo del suo studio di fase 3 HERO di ARD-101 per l'iperfagia nella sindrome di Prader-Willi (PWS).
L'emendamento riduce l'età minima di arruolamento da 13 a 10 anni, ampliando la popolazione di pazienti idonei. Il management ha citato il sostegno della comunità e dati storici che suggeriscono che i pazienti più giovani possano beneficiare maggiormente di un intervento precoce. L'azienda ha riaffermato un previsto lettura dei dati principali nel terzo trimestre del 2026.
Aardvark Therapeutics (Nasdaq: AARD) anunció la alineación de la FDA sobre una enmienda del protocolo de su ensayo de Fase 3 HERO de ARD-101 para la hiperfagia en el síndrome de Prader-Willi (PWS).
La enmienda reduce la edad mínima de inscripción de 13 a 10 años, ampliando la población de pacientes elegibles. La dirección citó el apoyo de la comunidad y datos históricos que sugieren que los pacientes más jóvenes podrían beneficiarse más de una intervención temprana. La empresa reafirmó una lectura de datos iniciales planificada para el Q3 de 2026.
Aardvark Therapeutics (Nasdaq: AARD)는 PRADER-WILLI 증후군(PWS)의 과식증에 대한 ARD-101의 3상 HERO 시험 프로토콜 수정에 대해 FDA의 조정을 발표했습니다.
수정 사항은 신청 최소 연령을 13세에서 10세로 낮추어 자격 환자군을 확대합니다. 경영진은 커뮤니티의 지지와 역사적 데이터를 근거로 더 어린 환자들이 조기 개입으로 더 큰 이점을 얻을 수 있다고 밝혔습니다. 회사는 2026년 3분기 상위 데이터 발표를 재확인했습니다.
Aardvark Therapeutics (Nasdaq: AARD) a annoncé l’alignement par la FDA sur un amendement du protocole de son essai de phase 3 HERO d’ARD-101 pour l’hyperphagie dans le syndrome de Prader-Willi (PWS).
L’amendement abaisse l’âge minimum d’inclusion de 13 à 10 ans, élargissant ainsi la population de patients éligibles. La direction a évoqué le soutien communautaire et des données historiques suggérant que les patients plus jeunes pourraient bénéficier davantage d’une intervention précoce. L’entreprise a réaffirmé une publication des données principales prévue au T3 2026.
Aardvark Therapeutics (Nasdaq: AARD) hat eine FDA-Übereinstimmung zu einer Protokolländerung für die Phase-3-Studie HERO von ARD-101 gegen Hyperphagie bei Prader-Willi-Syndrom (PWS) angekündigt.
Die Änderung senkt das Mindestalter für die Einschreibung von 13 auf 10 Jahre und erweitert damit die anrechenbare Patientenpopulation. Das Management verwies auf die Unterstützung der Gemeinschaft und historische Daten, die darauf hindeuten, dass jüngere Patienten stärker von einer frühzeitigen Intervention profitieren könnten. Das Unternehmen bekräftigte eine geplante Topline-Datenmeldung im Q3 2026.
Aardvark Therapeutics (Nasdaq: AARD) أعلنت عن توافق هيئة الغذاء والدواء الأمريكية على تعديل البروتوكول في تجربة المرحلة 3 HERO لـ ARD-101 لعلاج فرط الشهية في متلازمة برادر-ويلي (PWS).
يقلل التعديل الحد الأدنى لعمر التسجيل من 13 إلى 10 سنوات، موسعاً شريحة المرضى المؤهلين. أشار المديرون إلى دعم المجتمع والبيانات التاريخية التي تشير إلى أن المرضى الأصغر سناً قد يستفيدون بشكل أكبر من التدخل المبكر. وأكدت الشركة مجدداً خطة إصدار بيانات رئيسية في الربع الثالث من 2026.
Aardvark Therapeutics (Nasdaq: AARD) 宣布 FDA 就其第三阶段 HERO 试验 ARD-101 在 Prader-Willi 综合征（PWS）中的高食欲症的方案修订达成一致。
该修订将最低招募年龄从 13 岁降至 10 岁，扩大了符合条件的患者人群。管理层引用社区支持和历史数据，认为更年轻的患者可能从早期干预中受益更多。公司重申计划在 2026 年第三季度公布初步数据。
- FDA alignment on Phase 3 protocol amendment
- Eligibility expanded to ages 10+, increasing potential pool
- Planned topline readout in Q3 2026 for potentially pivotal trial
- None.
Protocol Expansion to Ages 10+ Aligned with FDA Guidance, Broadening Patient Population
SAN DIEGO, Oct. 08, 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, announces alignment with the U.S. Food and Drug Administration (FDA) on a protocol amendment to the company’s Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS). The protocol amendment changes the minimum age of eligibility to participate in the trial from 13 to 10 years old.
“Expansion of the Phase 3 HERO trial to include children 10 years of age and older will allow us to reach a larger segment of the PWS patient population to potentially serve more patients in need,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “This decision to expand eligibility is driven by support from the PWS community, alongside historical data showing that younger patients are more likely to benefit from early intervention. We look forward to our topline data readout for this potentially pivotal trial in the third quarter of 2026.”
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 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 press release 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 business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding the expected timeline for receiving topline data from the Phase 3 HERO trial, the potential for younger patients to benefit from early intervention and the potential pivotal nature of the Phase 3 HERO trial. 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 we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our 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 press release 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.
Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Carolyn.hawley@inizioevoke.com
FAQ
What change did Aardvark (AARD) make to the HERO Phase 3 trial eligibility on Oct 8, 2025?
How does the AARD protocol amendment affect the Prader-Willi syndrome patient population?
When does Aardvark expect topline results for the ARD-101 HERO Phase 3 trial?
Why did Aardvark expand the HERO trial to include children 10 years and older?
What is ARD-101 being tested to treat in the HERO trial (AARD)?
