Neothetics Announces Last Subject Enrolled in Phase 2 Proof of Concept Trial for LIPO-202 for the Reduction of Submental Subc...
March 20 2017 - 8:00AM
Neothetics, Inc. (NASDAQ:NEOT), a clinical-stage specialty
pharmaceutical company developing therapeutics for the aesthetic
market today announced completion of subject enrollment for its
Phase 2 proof of concept trial, LIPO-202-CL-31, for the reduction
of submental subcutaneous fat.
“We are excited to announce the conclusion of enrollment in our
first trial with LIPO-202 for the reduction of submental fat. We
are encouraged by the strong investigator interest and rapid
subject enrollment,” said Kim Kamdar Ph.D., a member of Neothetics’
Operating Committee and Board of Directors. “This is a robust
clinical trial design based on both our significant experience with
LIPO-202 and extensive feedback from key opinion leaders and
investigators on submental fat reduction.”
LIPO-202-CL-31 is a multi-center, randomized, double-blind,
placebo-controlled Phase 2 proof of concept trial to evaluate the
safety and efficacy of two doses of LIPO-202 versus placebo for the
reduction of submental bulging due to subcutaneous fat. The
trial has enrolled approximately 150 subjects at 12 sites across
the United States. Subjects will be randomized 1:1:1 and
receive up to either 0.3 mcg, or 3.0 mcg dose of LIPO-202, or
placebo. Subjects will receive up to 30 subcutaneous
injections of LIPO-202 or placebo once a week for eight weeks and
follow up visits to assess 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 subject’s submental region as evaluated by both the patient and
clinician, covering overall subject satisfaction and evaluation of
submental fat thickness by calipers.
The Company expects to report top-line data in June 2017.
About LIPO-202
LIPO-202 is a proprietary, first-in-class injectable formulation
of the well-known long-acting ß2-adrenergic receptor agonist,
salmeterol xinafoate, which is an active ingredient of FDA-approved
inhaled products such as SEREVENT DISKUS, ADVAIR HFA and ADVAIR
DISKUS. Our studies suggest that salmeterol xinafoate activates ß2
-adrenergic receptors on fat cells, triggering the body’s natural
process of metabolizing stored triglycerides (fat) resulting in a
reduction in size and volume of the fat cells in the treatment area
without damage of nearby tissues. LIPO-202 has an extremely
favorable safety profile, with little to no adverse post treatment
effects. LIPO-202 is being evaluated for the reduction of
submental fat commonly referred to as a double-chin.
About Neothetics, Inc.
Neothetics is a San Diego based clinical-stage specialty
pharmaceutical company developing therapeutics for the aesthetic
market. Our initial focus is on localized fat reduction and body
contouring. Our lead product candidate, LIPO-202, is a
first-in-class injectable formulation of the long-acting
ß2-adrenergic receptor agonist, salmeterol xinafoate, which is an
active ingredient in the U.S. Food and Drug Administration, or FDA,
approved inhaled products SEREVENT DISKUS, ADVAIR HFA and ADVAIR
DISKUS. 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 StatementsStatements 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,
2016 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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