Protocol for non-interventional patient registry presented at 57th Annual ESPE Meeting
BOSTON, Sept. 28, 2018 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM), a biopharmaceutical company focused on the development and commercialization of therapeutics for the treatment of rare genetic disorders of obesity, today announced the launch of a new non-interventional patient registry, called Tracing the Effect of the MC4R Pathway in Obesity (TEMPO). The TEMPO registry protocol is being presented at the 57th Annual European Society for Paediatric Endocrinology (ESPE) Meeting held September 27-29, 2018 in Athens, Greece.
“We are pleased to announce the launch of the TEMPO registry, a landmark effort to gather clinical information about people affected by rare genetic disorders that lead to insatiable hunger and severe obesity,” said Keith Gottesdiener, M.D., Chief Executive Officer of Rhythm. “This registry will support global efforts to measure the prevalence of these disorders and collect data on the burden of disease. Data from the registry will also help inform future research aimed at identifying effective strategies to improve patient care and management in the years ahead.”
The TEMPO registry is open to patients two years of age and older who present with severe obesity early in childhood and may experience insatiable hunger, also known as hyperphagia. Potential patients can be referred to coordinating centers by their healthcare provider, whether a treating physician, diagnosing physician or primary care physician, and must meet certain eligibility criteria. The registry will capture data entered by the patient as well as healthcare providers and caregivers using online survey tools administered at baseline and annually thereafter. Survey tools include questions on patient and caregiver demographics, physical activity, food and hunger episodes, quality of life, and caregiver perspective of burden of disease on the family.
“Obesity is one of the most prevalent chronic conditions in the U.S. and around the world. Rare genetic disorders of obesity include a subset of individuals who have a deficit, or variant, in genes that increase their risk for excessive appetite, poor satiety, and early-onset obesity,” said TEMPO registry principal investigator Ihuoma Eneli, M.D., Director of the Center for Healthy Weight and Nutrition at Nationwide Children's Hospital and Professor of Pediatrics at The Ohio State University. “We hope that as we learn more about these disorders we can decrease the bias and stigma often directed at people with severe obesity in our community.”
For more information about the TEMPO registry, visit ClinicalTrials.gov.
Rhythm is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. Rhythm is currently evaluating the efficacy and safety of setmelanotide, the Company’s first-in-class melanocortin-4 receptor (MC4R) agonist, in Phase 3 studies in patients with pro-opiomelanocortin (POMC) deficiency obesity (which includes deficiencies in both the POMC and PCSK1 genes) and leptin receptor (LEPR) deficiency obesity. Rhythm also supports The Genetic Obesity Project (www.GeneticObesity.com), which is dedicated to improving the understanding of severe obesity that results from specific genetic disorders. The company is based in Boston, MA.
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties, including statements regarding the impact of data from the TEMPO registry. Statements using word such as "expect", "anticipate", "believe", "may", "will" and similar terms are also forward looking statements. Such statements are subject to numerous risks and uncertainties, including but not limited to, the ability to gather data about people affected by rare genetic disorders of obesity and to successfully make use of that data, general risks associated with data analysis and reporting, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
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