Rhythm Pharmaceuticals Announces Acquisition of Xinvento B.V. & Portfolio of Investigational Therapeutics

Rhythm Pharmaceuticals, Inc. recently announced Rhythm’s Netherlands subsidiary, Rhythm Pharmaceuticals Netherlands B.V., acquired Xinvento B.V., a Netherlands-based biotech company focused on developing therapies for congenital hyperinsulinism (CHI). CHI is a rare genetic disease in which cells secrete excess insulin, causing hypoglycemia, which can result in serious health outcomes including seizures, coma, permanent brain damage, and death.

Xinvento was founded in 2021 by Claudine van der Sande, an experienced biopharmaceutical leader who previously held positions at Roche and Sanofi, and whose first-hand experience as a caregiver to her son living with CHI inspired her mission to seek a more effective treatment for CHI patients. Ms. van der Sande partnered with Dr. Piet Wigerinck, a medicinal chemist who served as chief scientific officer of Galapagos for 10 years, to lead the scientific effort. Xinvento is developing novel investigational therapeutic candidates designed to improve the care of patients with CHI.

Following the closing of this acquisition, Ms. van der Sande, Founder and CEO of Xinvento, will join Rhythm as Vice President, Head of CHI program, and will provide her deep subject matter expertise to the advancement of the CHI program.

“As a mother and primary caregiver to a child with CHI, Claudine knows that there is significant unmet need for new treatment options that can safely lower the frequency of hypoglycemic events and help minimize the incidence of irreversible brain damage in people born with CHI. In 2 short years, we believe she has driven a nimble, science-focused organization towards bringing a highly promising therapeutic candidate into the clinic,” said David Meeker, MD, Chair, President and Chief Executive Officer of Rhythm. “We are excited for the opportunity to expand our pipeline into CHI, a rare disease that is well aligned with our corporate strategy and our focus on rare endocrinology indications. We look forward to entering the clinic with a new therapeutic candidate in 2024.”

“I am confronted daily with the constant challenges and fears of living with CHI and the urgent need for an effective new treatment. I believe Rhythm’s deep clinical development, regulatory and commercial experience in rare diseases makes it the ideal partner to accelerate Xinvento’s CHI program,” said Ms. van der Sande. “I’m thrilled to join the Rhythm team to continue our work to bring a new therapy to patients and families who need improved options to treat this difficult, chronic disease.”

According to the terms of the acquisition agreement, Rhythm B.V. will purchase 100 percent of Xinvento’s fully diluted equity for an upfront payment of $5 million (subject to customary adjustments) with an additional payment of up to $6 million in preclinical development milestones and up to an additional $50 million payable upon certain U.S. or EU regulatory approvals. Rhythm B.V. will also pay up to an additional $150 million in certain commercial net sales milestones related to the lead candidate or a second molecule, in the event a second molecule is selected, developed and approved.

Congenital hyperinsulinism (CHI) is the most frequent cause of severe, random and persistent hypoglycemia in newborns and children. Hypoglycemia results from a dysregulation of insulin, which causes blood sugar levels to fall dangerously low. Without proper and immediate treatment, children with CHI may suffer seizures, coma, or even death and, longer term, patients may experience developmental delays, epilepsy, cerebral palsy, and other neurological damage. The estimated incidence rate for CHI is 1:29,000 to 1:31,000, according to the literature.

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases. Rhythm’s lead asset, IMCIVREE (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity caused by these diseases, is approved by the US FDA for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare MC4R pathway diseases, as well as a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.