纪要涉及的公司 Aardvark Therapeutics（股票代码：aard），一家位于加利福尼亚州圣地亚哥的上市公司 [2] 纪要提到的核心观点和论据 公司药物特点 - 公司有一款口服小分子药物，可靶向苦味受体，激活肠脑信号通路以抑制饥饿而非食欲 [3] - 药物通过肠道限制和激活肠脑CCK，经脑干调节饥饿，降低胃饥饿素水平，与GLP - 1作用途径不同且互补 [8] - 药物99%受肠道限制，因靶点在肠道腔内而发挥作用，提高了药物安全性，且可能与多种疗法产生叠加效果 [21] 临床项目布局 - 最先进的项目是针对普拉德威利综合征（Prader Willi syndrome）的潜在关键III期试验，预计2026年初有结果；还计划启动针对下丘脑性肥胖的II期项目，以及推进用于普通肥胖的ARD201制剂研发 [4] - 普拉德威利综合征在美国约有1 - 2.5万名患者，全球发病率约为1/15000，全球患者约35万或更多 [10] - 公司已在包括普拉德威利综合征在内的不同人群中完成了ARD101的I期和多个II期试验，超过70名患者接受了给药，未观察到超过2级的不良事件 [10][11] 普拉德威利综合征项目数据 - 18名普拉德威利综合征患者在28天的相对短时间内完成给药，低剂量组（200毫克，每日两次）患者的HQCT（食欲过盛评分）平均降低9分；剂量递增组患者的HQCT平均降低30%，符合III期纳入排除标准的患者降低48% [11][12][14] - 患者出现将食物留在盘子里、饥饿感明显缓解等情况，且药物可能改善焦虑、炎症和肠道运输等临床特征 [12] 与GLP - 1药物对比 - GLP - 1药物主要是抗食欲途径药物，会降低食物吸引力，与恶心相关，且会使胃饥饿素水平升高；而公司药物降低胃饥饿素水平，针对饥饿途径，与GLP - 1作用机制不同 [7][8][20] 其他项目情况 - 下丘脑性肥胖与普拉德威利综合征在机制和神经生理学上有很多相似之处，此前有临床数据显示血清CCK对下丘脑性肥胖的暴饮暴食有改善作用 [16][17] - ARD201是与TPD4抑制剂的固定剂量组合，增强了ARD101的活性，但因TPD4抑制剂可能导致胃轻瘫，不适用于普拉德威利综合征患者 [17][18] - 在普通肥胖患者的随机安慰剂对照II期研究中，观察到LDL和糖化血红蛋白A1c降低的信号，患者自我报告的饥饿评分显著降低，血清胃饥饿素水平也降低 [19] 未来研究计划 - EMPOWER研究是针对普通肥胖的研究，第一部分将展示药物在GLP - 1基础上的叠加效果和更好的瘦体重保留效果；第二部分将观察患者停用GLP - 1后的体重反弹情况，公司认为药物可防止体重反弹 [20][22] 其他重要但是可能被忽略的内容 - 公司执行团队经验丰富，拥有临床、监管和业务发展方面的专家 [5] - 普拉德威利综合征III期试验为传统设计，包括筛选期、治疗期（ARD101与安慰剂随机分组），主要终点是第12周HQCT与基线的比较，还设置了多个次要终点 [15][16] - 2026年2月将有多个数据读出，包括III期HERO试验以及下丘脑性肥胖和肥胖两个II期项目的顶线数据 [23]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-42513 AARDVARK THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 82-1606367 | | --- | --- | ...

Exhibit 99.1 Aardvark Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Highlights SAN DIEGO, CA, May 14, 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, today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. "We ...

Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS); data readout expected in early 2026$151.3 million in cash, cash equivalents, and short-term investments supports projected operations into 2027 SAN DIEGO, May 14, 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 ...

SAN DIEGO, May 07, 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 at the following conferences during May: Live webcasts of each presentation will be accessible on the company's website, www.aardvarktherapeutics.com, under the investors section and an archived record ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-42513 AARDVARK THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 82-1606367 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | I ...

Exhibit 99.1 Aardvark Therapeutics Reports Full Year 2024 Financial Results and Provides Business Highlights SAN DIEGO, March 31, 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, today reported financial results for the full year ended December 31, 2024, and provided business highlights. Forward-Lo ...