Release Details

BOSTON, Oct. 30, 2019 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that it will present clinical data from its two pivotal Phase 3 clinical trials evaluating setmelanotide for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities, as well as preclinical data characterizing missense variants within the melanocortin-4 receptor pathway, during the 37^th Annual Meeting of The Obesity Society at ObesityWeek^® 2019, Nov. 3-7, at Mandalay Bay South Convention Center in Las Vegas. Data from the Phase 3 trials in POMC and LEPR deficiency obesity will be presented during a special, late-breaking research forum, highlighting late-stage clinical data on novel anti-obesity medications.  

Details on the presentations are as follows:

Oral Presentations

ObesityWeek’s special late-breaking research forum, “Emerging Pharmacological Anti-obesity Therapies,” is Monday, Nov. 4, from 11 a.m. - 12:30 p.m. PT (2 - 3:30 p.m. ET) in Mandalay Bay Jasmine Ballroom ABCEFG. The forum includes:

• “Efficacy and Safety of the MC4R Agonist Setmelanotide in POMC Deficiency Obesity: A Phase 3 Trial,” presented by Peter Kühnen, M.D., Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Germany;  
• “Efficacy and Safety of the MC4R Agonist Setmelanotide in LEPR Deficiency Obesity: A Phase 3 Trial,” presented by Erica Van Den Akker, M.D., Ph.D., Erasmus MC-Sophia Children’s Hospital University in Rotterdam, Netherlands.

Poster Presentations

The same abstracts also will be presented during the Pharmacotherapy Late Breaking Poster Session on Thursday, Nov. 7, from 12 noon - 1:30 p.m. PT (3 p.m. - 4:30 p.m. ET) in Mandalay Bay’s Shoreline Exhibit Hall.

In addition, a third poster, “Functional Characterization of Missense Variants in LEPR, POMC, & PCSK1 Genes Arising From SNV,” will be presented during the CNS Poster Session on Wednesday, Nov. 5, 12 noon - 1:30 p.m. PT (3 p.m. - 4:30 p.m. ET), in the Shoreline Exhibit Hall.

About Rhythm
Rhythm is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. The company recently announced positive topline results from pivotal Phase 3 clinical trials of setmelanotide, its MC4R agonist, in patients with POMC deficiency obesity and LEPR deficiency obesity. The company plans to complete its first rolling new drug application (NDA) submission to the U.S. Food and Drug Administration in the fourth quarter of 2019 or the first quarter of 2020. Rhythm is also evaluating setmelanotide in a pivotal Phase 3 study in patients with Bardet-Biedl syndrome and Alström syndrome, and expects to complete enrollment in the second half of 2019. The company is leveraging the Rhythm Engine -- comprised of its Phase 2 basket study, TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of rare genetic disorders of obesity. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.

Forward-Looking Statements

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 Rhythm’s anticipated timing for enrollment of patients in clinical trials and submission of an NDA, its ongoing efforts related to patient identification, the timing of the release of results of clinical trials, the efficacy of setmelanotide in patients with POMC deficiency obesity, LEPR deficiency obesity, Bardet-Biedl syndrome, Alström syndrome, POMC heterozygous deficiency obesity, or POMC epigenetic disorders, as well as new indications that we may pursue. 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, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, and expenses, 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.

Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com

Investor Contact:
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com

Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

Source: Rhythm Pharmaceuticals, Inc.