Funding of $85 million secured for Prader-Willi Syndrome drug

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Aardvark Therapeutics has announced an $85 million oversubscribed Series C financing.

The funding will be used to complete the clinical trials required for regulatory approval of Aardvark’s lead asset, ARD-101, for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS), as well as to demonstrate ARD-101’s complementary mechanism of action to the current GLP-1 therapies in the treatment of obesity, and to advance other Aardvark pipeline programmes.

PWS is a severe neuro-developmental disorder with an incidence of about one 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 characterised 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.

The round was led by Decheng Capital, with participation from Cormorant Asset Management, Surveyor Capital, SymBiosis, Tetragon Financial Group, Walleye Capital, Laurion Capital Management, LG Technology Ventures, Cantor Fitzgerald & Co, Silver Arc Private Capital, The Prader-Willi Syndrome Association – USA, and existing investors, including Vickers Venture Partners and the Foundation for Prader-Willi Research.

Complementary to existing obesity drugs

Aardvark Therapeutics CEO, Tien Lee, commented: “We believe our lead compound, ARD-101, is a well-differentiated first-in-class drug candidate that is orthogonal and complementary to existing obesity drugs and reduces hunger through the selective induction of gut-brain signalling. 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. We are excited that our new and existing investors share our vision of ARD-101’s potential therapeutic impact and the relevance of TAS2R receptors as unique pharmaceutical targets.”

Dr Theresa Strong, Director of Research Programs at the Foundation for Prader-Willi Research (FPWR), said: “We are truly encouraged by the early findings of the ongoing trial of ARD-101 in young adults with PWS, which have shown marked decreases in hunger and food-seeking behaviour in several treated individuals. Based on these promising findings, the FDA has already granted ARD-101 Orphan Drug Designation and Rare Paediatric Disease Designation. With the FDA’s guidance and the now secured funds, our PWS community is looking forward to a rapid expansion of the clinical evaluation of ARD-101 in the hope of bringing this novel oral drug to patients in need.”

Megan Thomas, Multimedia Editor, DDW

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