Our Clinical Programs

We have assembled a portfolio of novel and proprietary small molecule programs that we believe can induce feelings of appetite satiety and fullness in patients with hunger-associated conditions.
Phase 1
Phase 2
Phase 3
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Prader-Willi Syndrome (PWS)
HERO Trial

ARD-101
Phase 1
Phase 2
Phase 3
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HERO Trial (Hunger Elimination or Reduction Objective)

ARD-101 is an investigational orally delivered small-molecule for the treatment of hyperphagia-related behavior in Prader-Willi Syndrome (PWS). We believe ARD-101’s unique ability to induce gut-localized CCK and GLP-1 secretion could result in a reduction in hyperphagia-related behaviors.

Hypothalamic Obesity (HO)
HONOR Trial

ARD-101
Phase 1
Phase 2
Phase 3
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HONOR Trial (Hypothalamic Obesity Neutralized On TAS2Rs)

ARD-101 is an investigational orally delivered small-molecule for the treatment of hyperphagia associated with Hypothalamic Obesity (HO). We believe ARD-101’s unique ability to induce gut-localized CCK and GLP-1 secretion could result in a reduction in hyperphagia for patients with Hypothalamic Obesity.

Obesity
Empower Trial

ARD-201
Phase 1
Phase 2
Phase 3
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EMPOWER Trial (Exploratory Multi-arm Prevention Of WEight Regain)

ARD-201 will be an investigational, fixed-dose combination of ARD-101 and a DPP-4 inhibitor for the potential treatment of obesity and obesity-related conditions. It will be designed to be taken orally once a day. We believe combining ARD-101 with a DPP-4 inhibitor will support weight management and address unmet needs in obesity care.

Last Updated: November 4, 2024

Expanded Access Program

We are committed to developing novel investigational therapies that address serious, unmet medical conditions for patients. To that end, we conduct clinical trials using our investigational therapeutics with the goal of gaining regulatory approval(s) to allow marketing of future products.

Currently, we do not make our investigational therapeutics available outside of our clinical trials, such as under an offer expanded access program. We encourage patients interested in gaining access to our investigational therapeutics to consult with their physician regarding potential participation in clinical trials. A listing of our and other clinical trials can be found at ClinicalTrials.gov. For any further questions, please direct your physician to contact us at [email protected].

Prader-Willi Syndrome

What is Prader-Willi?

Prader-Willi Syndrome (PWS) is a genetic neurodevelopmental disorder caused by a lack of expression of multiple genes on paternal chromosome 15. PWS is a rare disorder affecting an estimated 10,000 to 20,000 individuals in the United States and approximately 350,000 to 400,000 worldwide. The condition is characterized by developmental delays, physical and cognitive challenges, and severe hyperphagia that can lead to early onset obesity and metabolic disorders. PWS-associated hyperphagia manifests as a feeling of intense persistent hunger, food preoccupation, extreme drive to food-seeking behaviors that severely impact the life of both the patients and the caregivers.

Trial Summary

We are currently planning our Phase 3, placebo-controlled clinical trial, which is designed to evaluate the effect of ARD-101 on hyperphagia-related behavior in individuals aged 13 years and older who have a confirmed diagnosis of Prader-Willi Syndrome (PWS). Participants with hyperphagia-related behaviors, as measured by a clinical questionnaire score, may be eligible to enroll. The study is intended to be conducted across multiple sites within North America, Asia Pacific, and the European Union.

Hypothalamic Obesity

What is Hypothalamic Obesity?

Hypothalamic Obesity (HO) is a rare form of obesity that is a result of a variety of hypothalamic pathophysiologies in the brain. The hypothalamus is responsible for regulating fundamental biological processes such as temperature control, sleep cycles, and feeding behavior. This condition is characterized by uncontrollable hunger (hyperphagia), metabolic dysfunction, and weight gain. HO is most commonly caused by sequelae from the treatment of hypothalamic and pituitary tumors (e.g., craniopharyngiomas).

Trial Summary

We are planning a Phase 2, placebo-controlled clinical trial, which will be designed to evaluate the effect of ARD-101 on hyperphagia associated with Hypothalamic Obesity (HO).

Obesity

What is Obesity?

Obesity is a medical condition caused by a combination of biological, environmental, and lifestyle factors. It is marked by excessive body fat and a high BMI (>25 kg/m² is overweight, >30 kg/m² is obese). Obesity is linked to numerous comorbidities such as diabetes, hypertension, high cholesterol, coronary artery disease, cancer and liver pulmonary ailments.

The prevalence of Obesity presents a global health challenge, as over 1 billion individuals are living with Obesity. While there are FDA-approved pharmacologic treatments for obesity available, they may not be suitable for all patients.

Trial Summary

We are planning a Phase 2 multi-arm clinical trial, which will be designed to evaluate the effect of ARD-201 on a variety of parameters related to obesity and obesity-related conditions. It will also be evaluated for complementary effects to currently available therapies.