Neothetics Initiates Phase 2 Proof of Concept Trial for LIPO-202 for the Reduction of Submental Subcutaneous Fat
December 23 2016 - 8:00AM
Neothetics, Inc. (NASDAQ:NEOT) today announced the initiation of
the Phase 2 proof of concept trial, LIPO-202-CL-31, for LIPO-202
for the reduction of submental subcutaneous fat.
“The initiation of our Phase 2 proof of concept trial for
LIPO-202 for the reduction of submental fat is a significant
milestone for Neothetics,” said Kim Kamdar, Ph.D., a member of
Neothetics’ Operating Committee and Board of Directors. “We
continue to believe LIPO-202 could have exceptional impact in the
submental fat reduction market.”
LIPO-202-CL-31 is a multi-center, randomized, double-blind,
placebo-controlled Phase 2 proof of concept trial to assess the
safety and efficacy of two doses of LIPO-202 versus placebo for the
reduction of submental bulging due to subcutaneous fat. The
trial is expected to enroll a total of 150 patients at
approximately ten sites across the United States. Subjects
will receive up to 30 subcutaneous injections of LIPO-202 or
placebo once a week for eight weeks. Subjects will be
randomized 1:1:1 and receive either 0.3 mcg, or 3.0 mcg dose of
LIPO-202, or placebo. Follow up visits to access safety and
efficacy will occur one week and four weeks post the last
treatment.
The study endpoints include both safety and efficacy
measurements. Efficacy measures will assess improvement in the
patient’s submental region as evaluated by both the patient and
clinician, overall patient satisfaction and evaluation of submental
fat thickness by calipers.
The company expects to report top-line data from this trial in
late second quarter 2017.
More information about the Neothetics trials and
participating sites is available by
visiting www.clinicaltrials.gov.
About LIPO-202
LIPO-202 is an injectable formulation of salmeterol xinafoate, a
well-known long-acting ß2-adrenergic receptor agonist used in
several FDA-approved drugs, including ADVAIR® for asthma.
LIPO-202 is designed to be a locally-injected drug that causes
localized shrinking of fat cells without any effect on nearby
tissues. LIPO-202 activates ß2-adrenergic receptors on fat cells,
triggering the metabolism of triglycerides stored in the fat cells,
and thereby shrinking them across the treatment area.
About Neothetics, Inc.
Neothetics is a clinical-stage specialty pharmaceutical company
focused on development and commercialization of therapeutics for
the aesthetic market. Our current focus is on localized fat
reduction and body contouring. Neothetics’ product candidate,
LIPO-202, is a potential injectable treatment for undesirable,
localized areas of fat that requires no pain management before or
after treatment and no downtime without damage to nearby tissues.
For more information on Neothetics, please visit
www.neothetics.com. Neothetics, LIPO-202, LIPO-102 and the
Neothetics logo are trademarks or registered trademarks of
Neothetics, Inc. Other names and brands may be claimed as the
property of others.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements include, but are not limited to,
statements regarding the ability to develop a modified
formulation of LIPO-202, timing of conducting and obtaining results
from Phase 2 trials and proof of concept study with a modified
formulation of LIPO-202, whether our modified formulation of
LIPO-202 is able to demonstrate positive results,
Neothetics’ plans to research, develop and commercialize
LIPO-202 and other product candidates, our expectations regarding
the potential market size and opportunity of LIPO-202, as well as
expected timing for reporting results from clinical trials. Because
such statements are subject to risks and uncertainties, actual
results may differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon Neothetics’ current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with clinical trials, such as the ability to timely initiate
clinical trials and enroll a sufficient number of patients on a
timely basis into clinical trials, the extent to which top-line
data is available and whether the clinical trials achieve positive
results, product development activities, obtaining regulatory
approval to commercialize LIPO-202 and other product candidates,
Neothetics’ use of cash and the need to raise additional funding,
when needed, in order to conduct our clinical trials and other
business, the degree of market acceptance of LIPO-202 by
physicians, patients and others in the medical community, our
reliance on third parties, including third-party suppliers for
manufacturing and distribution of products, regulatory developments
in the United States and foreign countries, Neothetics’
ability to obtain and maintain intellectual property protection for
LIPO-202 and its product candidates, competition in the aesthetics
industry and other market conditions. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Neothetics undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made.
Investors should consult all of the information set forth herein
and should also refer to the risk factor disclosure set forth in
the reports and other documents the company files with
the SEC available at www.sec.gov, including without
limitation, Neothetics’ Form 10-K for the year ended December
31, 2015 and subsequent Quarterly Reports on Form 10-Q.
COMPANY CONTACTS:
Susan A. Knudson
Chief Financial Officer
858-500-7780
sknudson@neothetics.com
Fara Berkowitz, R.Ph, Pharm.D
Senior Director, Investor Relations and Corporate Development
646-494-1589
fberkowitz@neothetics.com
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