Prolor Biotech Announces Positive Results of Its Obesity/Diabetes Drug Candidate in Preclinical Weight Loss Study
—MOD-6030 Administered Once Weekly Over 30 Days Produced
28% Weight Loss and Improved Glycemic Profiles—
—Other Potential Health Benefits Included 57% Reduction in
Cholesterol Levels—
—Data to Be Presented at 5th Diabetes Drug Discovery and
Development Conference—
Nes-Ziona, Israel – April 17, 2012 – PROLOR Biotech,
Inc. (NYSE Amex: PBTH) today reported positive preclinical results
from an animal study of its long-acting obesity/Type II diabetes
drug candidate MOD-6030. The study was designed to measure the
potential therapeutic effect of MOD-6030 injected once weekly as
measured by weight loss, reduction in food intake, glycemic control
and cholesterol levels. The study results will be presented at
GTC’s 5th Diabetes Drug Discovery and Development Conference
on April 19, 2012 in Boston, MA.
In the study, MOD-6030 administered to diet-induced obese (DIO)
mice once weekly over a 30-day period demonstrated significant
efficacy in reducing weight, lowering blood glucose levels,
increasing insulin sensitivity and reducing cholesterol levels as
compared to a group that received placebo. Animals in the placebo
group showed minimal changes in the study parameters, while the
animals receiving MOD-6030 achieved on average a 28% reduction in
weight, a 29% reduction in food intake, a 19% reduction in blood
glucose levels and a 57% reduction in cholesterol levels. Body
composition analysis showed that the weight loss resulted
specifically from reductions in body fat.
“We believe there is great demand among obese patients and
their physicians for therapies that will help patients lose weight
and reduce elevated glucose levels resulting from obesity with
minimal side effects and a favorable administration profile,”
said Dr. Abraham Havron, CEO of PROLOR. “In this study in
animals, our MOD-6030 therapy demonstrated a unique combination of
achieving substantial weight loss and improved glycemic profiles
while also significantly lowering cholesterol levels.”
Dr. Havron continued, “MOD-6030 is a long-acting version of a
native peptide that acts as a natural satiety signal to reduce food
intake, and we believe it has the potential be a major new
treatment for obesity and Type II diabetes that is both effective
and safe. We are currently on track to initiate the first human
clinical trial of MOD-6030 in 2013.”
MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide, is a
long-acting version of oxyntomodulin, a naturally occurring hormone
that acts as a natural satiety signal to reduce food intake and
increase energy expenditure following food ingestion. Previous
third-party studies in humans showed that the native oxyntomodulin
can reduce appetite and food intake, leading to significant weight
loss without apparent side effects. However, as a result of its
very short half-life, oxyntomodulin has to be administered via
three daily injections. PROLOR developed MOD-6030, its
longer-acting version, by combining the naturally occurring hormone
with the company’s proprietary Reversible PEGylation
technology designed to increase the half-life of therapeutic
peptides and small molecules.
For more information on the 5th Diabetes Drug Discovery and
Development Conference, visit
www.gtcbio.com/component/conference/?file=home&cn=5th+Diabetes+Drug+Discovery+&Development=&cid=16.
ABOUT PROLOR PROLOR Biotech, Inc. is a clinical stage
biopharmaceutical company applying unique technologies, including
its patented CTP technology, primarily to develop longer-acting
proprietary versions of already approved therapeutic proteins that
currently generate billions of dollars in annual global sales. The
CTP technology is applicable to virtually all proteins. PROLOR is
currently developing a long-acting version of human growth hormone,
which has successfully completed a Phase II clinical trial. It also
is developing long-acting versions of Factor VIIa and Factor IX for
hemophilia and a GLP-1/Glucagon dual receptor agonist peptide for
diabetes and obesity, as well as agents for atherosclerosis and
rheumatoid arthritis, which are all in preclinical development. For
more information, visit www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking
statements, which may be identified by words such as
“expects,” “plans,” “projects,”
“will,” “may,” “anticipates,”
“believes,” “should,” “would”,
“intends,” “estimates,”
“suggests,” “has the potential to” and
other words of similar meaning, including statements regarding the
results of current clinical studies and preclinical experiments and
the effectiveness of PROLOR’s long-acting protein programs,
which are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Investors are
cautioned that forward-looking statements involve risks and
uncertainties that may affect PROLOR’s business and
prospects, including the risks that PROLOR may not succeed in
generating any revenues or developing any commercial products,
including any long-acting versions of human growth hormone,
erythropoietin, interferon beta, GLP-1 and other products; that the
long-acting products in development may fail, may not achieve the
expected results or effectiveness and/or may not generate data that
would support the approval or marketing of these products for the
indications being studied or for other indications; that ongoing
studies may not continue to show substantial or any activity; that
the actual dollar amount of any grants from Israel’s Office
of the Chief Scientist is uncertain and is subject to policy
changes of the Israeli government, and that such grants may be
insufficient to assist with product development; and other risks
and uncertainties that may cause results to differ materially from
those set forth in the forward-looking statements. The results of
clinical trials in humans may produce results that differ
significantly from the results of clinical and other trials in
animals. The results of early-stage trials may differ significantly
from the results of more developed, later-stage trials. The
development of any products using the CTP platform technology could
also be affected by a number of other factors, including unexpected
safety, efficacy or manufacturing issues, additional time
requirements for data analyses and decision making, the impact of
pharmaceutical industry regulation, the impact of competitive
products and pricing and the impact of patents and other
proprietary rights held by competitors and other third parties. In
addition to the risk factors described above, investors should
consider the economic, competitive, governmental, technological and
other factors discussed in PROLOR’s filings with the
Securities and Exchange Commission. The forward-looking statements
contained in this press release speak only as of the date the
statements were made, and we do not undertake any obligation to
update forward-looking statements, except as required under
applicable law.
Barbara Lindheim
BioCom Partners LLC
1375 Broadway - 11th floor
New York, NY 10018
212.584.2276 x201 (office)
917.355.9234 (mobile)
Posted: April 2012
