Rare Daily Staff

Rhythm Pharmaceuticals said CEO and President Keith Gottesdiener will step down once the company applies to the U.S. Food and Drug Administration for approval for its rare obesity drug setmelanotide, as the company readies to transition into a commercial enterprise.

The Board has formed a search committee and retained an executive search firm to assist in identifying Gottesdiener’s successor. Gottesdiener will also step down from the company’s board.

“Under Keith’s leadership, Rhythm has become a recognized leader in rare genetic disorders of obesity, advancing setmelanotide through late-stage clinical development in four indications, identifying additional melanocortin-4 receptor (MC4R) pathway disorders that may be amenable to treatment, and building a robust community of healthcare providers, advocacy groups, patients, and families to better understand, identify, and treat people living with these conditions,” said Rhythm Chairman David Meeker.

In August of 2019, Rhythm announced the achievement of positive topline results from its pivotal phase 3 clinical trials evaluating setmelanotide, the company’s MC4R agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities.

POMC deficiency obesity is a disorder caused by variants in the POMC or PCSK1 genes that can often lead to severe obesity beginning early in life, insatiable hunger, endocrine abnormalities, including adrenocorticotropic hormone deficiency and mild hypothyroidism, red hair, and light skin pigmentation. LEPR deficiency obesity is a disorder caused by variants in the LEPR gene that can often lead to severe obesity beginning early in life, insatiable hunger, and endocrine abnormalities, including hypogonadotropic hypogonadism and hypothyroidism.

Setmelanotide activates MC4R, part of the key biological pathway that independently regulates hunger and body weight. Variants in genes within the MC4R pathway are associated with unrelenting hunger and severe, early-onset obesity.

Rhythm expects to complete the submission of a rolling New Drug Application to the FDA that will cover both POMC and LEPR deficiency obesities in the first quarter of 2020.

Photo: Keith Gottesdiener, CEO of Rhythm Pharmaceuticals

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