Rhythm Pharmaceuticals to Provide Update on Phase 2 Basket Study and Genetic Sequencing Efforts
January 19 2021 - 8:00AM
Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical
company aimed at developing and commercializing therapies for the
treatment of rare genetic diseases of obesity, today announced that
it plans to host a virtual event on Tuesday, January 26, 2021 from
8 to 10 a.m. ET to provide an update on its ongoing exploratory
Phase 2 Basket Study and genetic sequencing efforts.
At the event, Rhythm management plans to report data for
setmelanotide in individuals living with heterozygous (HET) obesity
due to genetic variants in one of two alleles of the POMC,
PCSK1 or LEPR gene, as well as SRC1 and SH2B1
deficiency obesities, and plans to provide an update on data from
the Company’s sequencing efforts, which now comprises samples from
approximately 37,500 individuals with severe obesity.
A live webcast of the event will be available under “Events
& Presentations” in the Investors & Media section of the
Company’s website at http://www.rhythmtx.com. A replay of the
webcast will be available on the Rhythm website for 30 days
following the event.
About Rhythm PharmaceuticalsRhythm is a
commercial-stage biopharmaceutical company committed to
transforming the treatment paradigm for people living with rare
genetic diseases of obesity. The company’s precision medicine,
IMCIVREE™ (setmelanotide), has been approved by the FDA for chronic
weight management in adult and pediatric patients 6 years of age
and older with obesity due to POMC, PCSK1 or LEPR deficiency
confirmed by genetic testing. IMCIVREE is the first-ever FDA
approved therapy for these rare genetic diseases of obesity. Rhythm
is advancing a broad clinical development program for setmelanotide
in other rare genetic diseases of obesity. The Company is
leveraging the Rhythm Engine and the largest known obesity DNA
database - now with more than 30,000 sequencing samples - to
improve the understanding, diagnosis and care of people living with
severe obesity due to certain genetic deficiencies. 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.
IMCIVREE™ (setmelanotide) Indication IMCIVREE
is indicated for chronic weight management in adult and pediatric
patients 6 years of age and older with obesity due to
proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin
type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The condition
must be confirmed by genetic testing demonstrating variants in
POMC, PCSK1, or LEPR genes that are interpreted as pathogenic,
likely pathogenic, or of uncertain significance (VUS).
Limitations of Use
IMCIVREE is not indicated for the treatment of patients with the
following conditions as IMCIVREE 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; and
- Other types of obesity not related to POMC, PCSK1 or LEPR
deficiency, including obesity associated with other genetic
syndromes and general (polygenic) obesity.
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Sexual adverse
reactions may occur in patients treated with IMCIVREE. Spontaneous
penile erections in males and sexual adverse reactions in females
occurred in clinical studies with IMCIVREE. Instruct patients who
have an erection lasting longer than 4 hours to seek emergency
medical attention.
Depression and Suicidal Ideation: Some drugs
that target the central nervous system, such as IMCIVREE, may cause
depression or suicidal ideation. Monitor patients for new onset or
worsening of depression. Consider discontinuing IMCIVREE if
patients experience suicidal thoughts or behaviors.
Skin Pigmentation and Darkening of Pre-Existing
Nevi: IMCIVREE may cause generalized increased skin
pigmentation and darkening of pre-existing nevi due to its
pharmacologic effect. This effect is reversible upon
discontinuation of the drug. Perform a full body skin examination
prior to initiation and periodically during treatment with IMCIVREE
to monitor pre-existing and new skin pigmentary
lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol
Preservative in Neonates and Low Birth Weight Infants:
IMCIVREE is not approved for use in neonates or infants.
ADVERSE REACTIONS
- The most common adverse reactions (incidence ≥23%) were
injection site reactions, skin hyperpigmentation, nausea, headache,
diarrhea, abdominal pain, back pain, fatigue, vomiting, depression,
upper respiratory tract infection, and spontaneous penile
erection.
USE IN SPECIFIC POPULATIONSDiscontinue IMCIVREE
when pregnancy is recognized unless the benefits of therapy
outweigh the potential risks to the fetus. Treatment with IMCIVREE
is not recommended for use while 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 Full Prescribing Information for IMCIVREE.
Forward-Looking StatementsThis 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 limitation statements regarding the potential,
safety, efficacy, and regulatory and clinical progress of
setmelanotide, the anticipated timing for release of clinical data,
data to be presented in the upcoming presentation and our business
strategy and plans. 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, risks
associated with data analysis and reporting, the impact of the
COVID-19 pandemic on our business and operations, including our
preclinical studies, clinical trials and commercialization
prospects, and the other important factors discussed under the
caption “Risk Factors” in our Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2020 and our 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
Investor Contact:Hannah DeresiewiczStern
Investor Relations,
Inc.212-362-1200hannah.deresiewicz@sternir.com
Media Contact:Adam DaleyBerry & Company
Public Relations212-253-8881adaley@berrypr.com
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