Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global
commercial-stage biopharmaceutical company focused on transforming
the lives of patients living with rare neuroendocrine diseases,
today announced that David Meeker, M.D., Chair, President and
Chief Executive Officer, will participate in fireside chats at two
upcoming investor conferences:
- Guggenheim Securities Healthcare Innovation Conference on
Monday, November 11 at 11:30 a.m. ET
- Stifel 2024 Healthcare Conference on Monday, November 18, 2024,
at 11:30 a.m. ET
The fireside chats will be webcasted and available under “Events
& Presentations” in the Investor Relations section of the
Company’s website at www.rhythmtx.com, and webcast replays
will be available for 30 days following the presentations.
About Rhythm PharmaceuticalsRhythm is a
commercial-stage biopharmaceutical company committed to
transforming the lives of patients with rare neuroendocrine
diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R
agonist designed to treat hyperphagia and severe obesity, is
approved by the U.S. Food and Drug Administration (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. The EC has also authorized
setmelanotide for control of hunger and treatment of obesity in
children as young as 2 years old, living with BBS or POMC, PCSK1,
or LEPR deficiency. Additionally, Rhythm is advancing a broad
clinical development program for setmelanotide in other rare
diseases, as well as investigational MC4R agonists LB54640 and
RM-718, and a preclinical suite of small molecules for the
treatment of congenital hyperinsulinism. Rhythm’s headquarters is
in Boston, MA.
Setmelanotide IndicationIn the United States,
setmelanotide is indicated for chronic weight management in adult
and pediatric patients 6 years of age and older with monogenic or
syndromic obesity due to POMC, PCSK1 or LEPR deficiency as
determined by an FDA-approved test demonstrating variants in POMC,
PCSK1 or LEPR genes that are interpreted as pathogenic, likely
pathogenic, or of uncertain significance (VUS) or BBS.
In the European Union, setmelanotide is indicated for the
treatment of obesity and the control of hunger associated with
genetically confirmed BBS or loss-of-function biallelic POMC,
including PCSK1, deficiency or biallelic LEPR deficiency in adults
and children 2 years of age and above. In Europe, setmelanotide
should be prescribed and supervised by a physician with expertise
in obesity with underlying genetic etiology.
Limitations of Use
Setmelanotide is not indicated for the treatment of patients
with the following conditions as setmelanotide would not be
expected to be effective:
- Obesity due to suspected POMC, PCSK1 or LEPR deficiency with
POMC, PCSK1 or LEPR variants classified as benign or likely
benign.
- Other types of obesity not related to POMC, PCSK1 or LEPR
deficiency, or BBS, including obesity associated with other genetic
syndromes and general (polygenic) obesity.
ContraindicationPrior serious hypersensitivity
to setmelanotide or any of the excipients in IMCIVREE. Serious
hypersensitivity reactions (e.g., anaphylaxis) have been
reported.
WARNINGS AND PRECAUTIONS
Skin Pigmentation and Darkening of Pre-Existing
Nevi: Generalized increased skin pigmentation and
darkening of pre-existing nevi have occurred because of its
pharmacologic effect. Full body skin examinations prior to
initiation and periodically during treatment should be conducted to
monitor pre-existing and new pigmentary lesions.
Heart rate and blood pressure monitoring: In
Europe, heart rate and blood pressure should be monitored as part
of standard clinical practice at each medical visit (at least every
6 months) for patients treated with setmelanotide.
Disturbance in Sexual Arousal: Spontaneous
penile erections in males and sexual adverse reactions in females
have occurred. Patients who have an erection lasting longer than 4
hours should seek emergency medical attention.
Depression and Suicidal Ideation: Depression
and suicidal ideation have occurred. Patients should be monitored
for new onset or worsening depression or suicidal thoughts or
behaviors. Consideration should be given to discontinuing
setmelanotide if patients experience suicidal thoughts or
behaviors, or clinically significant or persistent depression
symptoms occur.
Hypersensitivity Reactions: Serious
hypersensitivity reactions (e.g., anaphylaxis) have been reported.
If suspected, advise patients to promptly seek medical attention
and discontinue setmelanotide.
Pediatric Population: The prescribing physician
should periodically assess response to setmelanotide therapy. In
growing children, the impact of weight loss on growth and
maturation should be evaluated. In Europe, the prescribing
physician should monitor growth (height and weight) using age- and
sex-appropriate growth curves.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol
Preservative in Neonates and Low Birth Weight Infants:
Setmelanotide is not approved for use in neonates or infants.
Serious and fatal adverse reactions including “gasping syndrome”
can occur in neonates and low birth weight infants treated with
benzyl alcohol-preserved drugs.
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) included skin
hyperpigmentation, injection site reactions, nausea, headache,
diarrhea, abdominal pain, vomiting, depression, and spontaneous
penile erection.
USE IN SPECIFIC POPULATIONS
Lactation: Not recommended when
breastfeeding.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm
Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch. See section 4.8 of the Summary of Product
Characteristics for information on reporting suspected adverse
reactions in Europe.
Please see the full U.S. Prescribing Information and EU
Summary of Product Characteristics for additional Important Safety
Information.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without including without
limitation statements regarding the safety, efficacy, potential
benefits of, and clinical design or progress of any of our products
or product candidates at any dosage or in any indication, our
participation in upcoming events and presentations, and the date,
time and content thereof and the timing of any of the foregoing .
Statements using words 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, our ability to successfully commercialize
setmelanotide, our liquidity and expenses, our ability to retain
our key employees and consultants, and to attract, retain and
motivate qualified personnel, and general economic conditions, and
the other important factors discussed under the caption “Risk
Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three
months ended September 30, 2024 and other filings 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 ConnollyHead of Investor Relations and
Corporate CommunicationsRhythm Pharmaceuticals,
Inc.857-264-4280dconnolly@rhythmtx.com
Media Contact:Sheryl
SeapyReal Chemistry(949) 903-4750sseapy@realchemistry.com
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