Aardvark Therapeutics, a San Diego-based biotech company, is on track for an initial public offering (IPO) this summer. The company is developing a weight loss pill, ARD-101, that has shown promise in early-stage trials. ARD-101 works differently from other weight loss drugs by targeting two gut hormones, GLP-1 and CCK, which could potentially reduce side effects.
Investors are excited about Aardvark’s progress. The company is close to finalizing a pre-IPO funding round of $75 million to $100 million from major healthcare investors. A successful IPO could raise an additional $150 million to $200 million, valuing the company at close to $2 billion.
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Aardvark’s lead drug, ARD-101, has shown success in suppressing hunger cravings in patients with Prader-Willi syndrome (PWS), a rare genetic disorder that causes obesity. It has also shown similar promise in people with general obesity. If phase 3 trials are successful, ARD-101 could be brought to market by 2026, offering a much-needed treatment option for PWS patients.
Prader-Willi Syndrome (PWS)
PWS is a severe neurodevelopmental disorder with a prevalence 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 morbid obesity in early childhood, accompanied by developmental delays and musculoskeletal malformations. Obesity in PWS is driven by hyperphagia and mitigated by strict control of food intake. The strict food control, if anything, exacerbates the hyperphagia and is stressful for those afflicted as well as the caregivers.
ARD-101 is differentiated from other treatment options
ARD-101 has been shown to be safe and substantially gut-restricted. Yet ARD-101 conveys its systemic effects by activating secretion of several gut peptide hormones, including GLP-1, GLP-2, and cholecystokinin (CCK). Gut CCK has long been recognized as the “satiety signal”, acting via the gut-brain axis, to control hunger. While PWS patients have a normal CCK receptor, their CCK release from gut enteroendocrine I-cells in response to food is impaired, leaving PWS patients with a continuous sense of extreme hunger.
In June 2023, The FDA granted Aardvark Orphan Drug Designation for the use of ARD-101 in PWS, based on early results of an ongoing Phase 2 trial of oral ARD-101 in young adults with PWS.
GLP-1 Weight Loss Drugs
Aardvark’s unique approach could significantly impact the GLP-1 weight loss drug category. By activating both GLP-1 and CCK, ARD-101 has the potential to reduce the nausea and muscle-wasting side effects that limit the long-term appeal of current GLP-1 drugs. If successful, this could position ARD-101 as a more desirable and sustainable treatment option, expanding the patient base for GLP-1 based therapies.
The potential market for weight loss drugs is significant, with analysts projecting it to reach $150 billion by the end of the decade. Aardvark’s IPO coincides with a renewed interest in the biotech sector after years of declines.
Aardvark’s success hinges on the continued positive results of ARD-101 trials. If the drug proves effective and avoids the side effects associated with other weight loss medications, it could become a major player in the anti-obesity market.