Aardvark Therapeutics Expands Management Team with Two Key Hires

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Sep 10, 2024, 07:00 ET

Chief Medical Officer
Head of Regulatory Affairs

SAN DIEGO, Sept. 10, 2024 /PRNewswire/ -- Aardvark Therapeutics, Inc., a biopharmaceutical company, announced the appointment of Manasi Sinha Jaiman, M.D., M.P.H. as Chief Medical Officer and Tom Bicsak, Ph.D., as Head of Regulatory Affairs today.

Commenting on the new hires, Aardvark CEO Tien Lee, M.D. said, "These new key positions will significantly accelerate the development of our lead investigational asset, ARD-101, which is designed to suppress the signs and symptoms of hunger and help reduce the effects of obesity and other indications."

ARD-101, Aardvark Therapeutics' lead compound, is a first-in-class small-molecule bitter taste receptor (TAS2R) pan-agonist. Oral ARD-101 is a largely gut-restricted compound that is thought to bind enteroendocrine cells to stimulate release of Cholecystokinin (CCK). CCK is normally released in response to large meals and stimulates the vagus nerve through the gut-brain axis to send signals of satiety to the brain. It has promising activity for patients with Prader-Willi Syndrome (PWS), a genetic disease associated with unabating hunger, i.e., hyperphagia. A defect in CCK production in PWS patients has been implicated as a key driver of hyperphagia. In addition to utility in treating PWS, the ability to suppress hunger could be useful in the treatment of general obesity in a way that complements the appetite suppressing abilities of the growing number of GLP-1 mimetics. Hunger is one of the key reasons that overweight people have trouble complying with diet regimens.

Dr. Lee further commented, "We believe ARD-101 is a well-differentiated first-in-class drug candidate that is orthogonal and complementary to existing obesity drugs, which reduces hunger through the selective induction of gut-brain signaling. The novel mechanism of action and gut-restricted nature of ARD-101 contribute to its encouraging safety and tolerability profile, as well as its broad-spectrum of activity. These additions to our management team will help us to get this treatment to patients as quickly as possible."

About Manasi Sinha Jaiman, M.D., M.P.H.

Prior to joining Aardvark, Dr. Jaiman was Vice President at Vertex Pharmaceuticals and Chief Medical Officer of ViaCyte where she developed novel approaches in cell therapy.

Previously she was an attending physician at Harvard Medical School and Massachusetts General Hospital, where she was responsible for the clinical care of pediatric endocrinology patients, including those with diabetes, metabolic disease, obesity, and Prader-Willi Syndrome. She also served as a co-investigator for several trials developing the bionic pancreas at Massachusetts General Hospital.

Dr. Jaiman received her M.D. from Medical University of South Carolina and her M.P.H. from Tulane University School of Public Health and Tropical Medicine. She completed her pediatric residency at Dartmouth-Hitchcock Medical Center and her endocrinology fellowship, which focused on type 1 diabetes research, at Massachusetts General Hospital.

Dr. Jaiman commented, "As a pediatric endocrinologist, the ability to directly impact the root causes of hyperphagia in PWS patients is an exciting opportunity because it aims to decrease the immense burden these patients and families face. My background in endocrinology with a focus on metabolic disease and diabetes makes this a particularly interesting science to be involved with at this exciting time."

About Tom Bicsak, Ph.D.

Dr. Bicsak is a regulatory affairs professional with nearly 35 years of experience in all phases of drug development. Prior to joining Aardvark, Dr. Bicsak worked at Biosplice, Elcelyx, Orexigen, Amylin, Dura, and Johnson & Johnson in therapeutic areas including endocrine/cardiometabolic disorders, hematology, immunology/inflammation, oncology, pulmonary/respiratory medicine, rare inherited diseases, renal disease, rheumatology/pain, and wound healing. He was a significant contributor to multiple marketing approvals in the United States and European Union, including Bydureon, Byetta, Contrave/Mysimba, Procrit/Eprex, Regranex, and Symlin.

Dr. Bicsak received his B.A. in Biochemistry from Rutgers University and his Ph.D. in Chemistry from the University of California, San Diego. He completed postdoctoral studies in Reproductive Endocrinology at the University of California, San Diego.

Dr. Bicsak said, "Much of my career has been focused on developing treatments for endocrinologic disorders and I am excited about the opportunity to work with a patient population in such desperate need of a new treatment alternative."

About Prader-Willi Syndrome (PWS)

PWS is a severe neuro-developmental disorder with an incidence of about 1 in 15,000-20,000 births. The disorder is caused by the loss of function of several genes located on chromosome 15. PWS impacts multiple organ systems and is characterized by metabolic, endocrine, and neurological dysfunction. One of the hallmark characteristics of PWS is hyperphagia-driven extreme and unrelenting hunger accompanied by developmental delays and musculoskeletal malformations. There are currently no approved therapies for the treatment of hyperphagia, which affects the health and quality of life of children and adults with PWS.About Aardvark Therapeutics, Inc. and ARD-101

Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, inflammation, and other indications. Aardvark's lead investigational compound, oral ARD-101, is a potent bitter taste receptor (TAS2R) pan-agonist that 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. Data from ARD-101 studies supports its ability to reduce hunger when used alone or in combination with other currently available therapies. Based on promising clinical data from an ongoing ARD-101 trial, the FDA has granted the drug both Orphan Drug designation and Rare Pediatric Rare Disease designation in PWS.
For more information visit www.aardvarktherapeutics.com.

SOURCE Aardvark Therapeutics, Inc.