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
Linda Shapiro Manning, M.D., Ph.D., Senior Vice President,
Clinical, will be promoted to Chief Medical Officer (CMO) effective
September 10, 2021. She will succeed Murray Stewart, M.D., who will
transition from his current role to Senior Medical Advisor
effective as of the same date.
“We are thrilled to promote Linda to CMO as we initiate our next
wave of clinical trials, including our pivotal EMANATE Phase 3
trial and DAYBREAK Phase 2 trial. Linda already has made meaningful
contributions across our clinical development, medical and
regulatory efforts since coming on board as a senior vice president
in July,” said David Meeker, Chair, President and Chief Executive
Officer of Rhythm. “With her strong track record both as a
practicing physician specializing in obesity and deep experience in
multiple leadership roles in the biopharmaceutical industry, Linda
is the right leader for Rhythm as we expand our understanding of
setmelanotide in the treatment of rare genetic diseases of
obesity.”
Dr. Shapiro joined Rhythm as Senior Vice President, Clinical, in
July, bringing more than 20 years of experience in obesity
medicine. She spent the previous decade in the biopharmaceutical
industry, with clinical development and medical affairs roles at
Applied Therapeutics, Boehringer Ingelheim, Merck and Novo
Nordisk. In these roles, she led clinical development for assets in
type 2 diabetes and cardiometabolic conditions and, at Novo
Nordisk, she served as head of medical science and international
medical director for the company’s GLP-1 and obesity global
development programs. Prior to joining industry, Dr.
Shapiro practiced medicine in Colorado, obtaining
certification and specializing in obesity medicine. She holds a
Ph.D. and completed a post-doctoral research fellowship in
kinesiology and applied physiology from the University of
Colorado, an M.D. from Tulane University School of Medicine,
and a bachelor’s degree in exercise science from
the University of Southern California.
Dr. Shapiro said, “I am excited about what Rhythm is ready to
accomplish. Murray has built capable and competent teams across
clinical, medical and regulatory as well as positive relationships
with external collaborators, and I look forward to leading these
teams forward and further supporting the collaborations as we
advance our mission of transforming the care of patients with rare
diseases of obesity. Setmelanotide has already established itself
as a first-in-class precision medicine for people living with
obesity due to POMC, PCSK1 or LEPR deficiency, and I believe it has
the potential to provide similarly meaningful benefit to people
with obesity caused by variants in many other genes in the MC4R
pathway.”
Dr. Meeker concluded, “Murray has been instrumental in
establishing Rhythm as the leader in the development of new
medicines and transforming the care for patients with rare genetic
diseases of obesity and developing a community of health care
providers, patients, caregivers and patient advocates. He led
efforts to secure our first U.S. and European approvals, gain
regulatory alignment for multiple phase 2 and 3 trials of
setmelanotide and prepare Bardet-Biedl and Alström syndrome
regulatory submissions. As Murray transitions from the CMO role, we
are in a strong position to continue advancing setmelanotide and
will be able to continue to leverage Murray’s knowledge and
experience as an active senior medical advisor supporting our BBS
regulatory submissions and clinical development efforts. We look
forward to continuing to benefit from Murray’s
involvement.”
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), was approved
in November 2020 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 obesity due to
POMC, PCSK1 or LEPR deficiency confirmed by genetic testing and by
the European Commission (EC) in July 2021 for
the treatment of obesity and the control of hunger associated with
genetically confirmed loss-of-function biallelic POMC, including
PCSK1, deficiency or biallelic LEPR deficiency in adults and
children 6 years of age and above. IMCIVREE is the first-ever FDA
and EC-approved therapy for patients with 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 approximately
37,500 sequencing samples—to improve the understanding, diagnosis
and care of people living with severe obesity due to certain
genetic deficiencies. The company is based in Boston, MA.
IMCIVREE® (setmelanotide)
IndicationIn the United States, 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).
In the EU, IMCIVREE is indicated for the treatment of obesity
and the control of hunger associated with genetically confirmed
loss-of-function biallelic POMC, including PCSK1, deficiency or
biallelic LEPR deficiency in adults and children 6 years of age and
above. IMCIVREE should be prescribed and supervised by a physician
with expertise in obesity with underlying genetic etiology.
Limitations of UseIMCIVREE 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;
- 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, and expectations regarding the CMO transition. Such
statements are subject to numerous risks and uncertainties,
including, but not limited to, the impact of our management
transition, 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 liquidity
and expenses, the impact of the COVID-19 pandemic on our business
and operations, including our preclinical studies, clinical trials
and commercialization prospects, and general economic conditions,
and the other important factors discussed under the caption “Risk
Factors” in our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2021 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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