- Taldefgrobep is a novel myostatin inhibitor with the potential
to be an important therapy for neuromuscular disorders and
metabolic diseases including obesity.
- Taldefgrobep monotherapy significantly reduced fat and
increased lean muscle mass in an obese mouse model; potential body
composition changes relevant to individuals living with overweight
and obesity.
- Biohaven presented an analysis supporting change in waist
circumference as a strong correlate for weight loss, suggesting
potential alternative endpoints for obesity studies.
NEW
HAVEN, Conn., Oct. 16,
2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN)
("Biohaven"), announced the presentation of preclinical data
demonstrating the ability of taldefgrobep alfa to significantly
reduce fat mass while increasing lean mass in an obese mouse model.
Separately, data supporting the correlation between change in waist
circumference and change in total body weight among adults living
with overweight and obesity treated with approved anti-obesity
medications were reported. Both sets of data were presented on
October 15, 2023 at The Obesity
Society's annual ObesityWeek conference held in Dallas, TX.
Poster 210: Correlation Between Reduction in Total Body
Weight and Change in Waist Circumference
Poster 211: Taldefgrobep Alfa Reduces Fat and Increases
Muscle in an Obese Mouse Model
The poster presentations hightlight the potential benefit of
taldefgrobep in the treatment of adults living with overweight and
obesity and suggest anthropometric measures of central obesity,
such as waist circumference or waist-to-height ratio, may be
considered as effective alternative estimations of therapeutic
effect.
In a mouse model of diet-induced obesity, untreated mice
exhibited an increase in fat mass of 31%, while the
taldefgrobep-treated mice demonstrated increases in lean mass of
25% from baseline (p£.0.001; Figure 1) and lost 11% of their
baseline fat (p£.0.001; Figure 2) compared to vehicle (placebo)
treated mice. Insulin and leptin levels were consistently lower in
taldefgrobep-treated mice compared to untreated. There was no
difference in food intake over time across the taldefgrobep and
untreated mice, counter to what has been observed with incretin
mimetics (e.g., semaglutide) which are consistently associated with
a reduction in energy intake.
"The disease of obesity is a public health crisis for which
alternative treatment options remain necessary. With the
unprecedented amount of weight loss generated by the latest
anti-obesity medications, it is important that we carefully
consider the quality of resulting body composition changes,
including the degree of lean muscle loss. Taldefgrobep's
differentiated mechanism offers the potential for a meaningful
reduction in fat mass, the primary pathogenic tissue in obesity,
while increasing lean mass. These body changes are unique relative
to all approved anti-obesity medications which achieve reductions
in total body weight based on a composite of fat mass loss and lean
muscle mass loss, the latter of which may pose important adverse
long-term health consequences" said Peter
Ackerman, M.D., Vice President and Clinical Lead for
Metabolic Disorders at Biohaven.
A Phase 2 obesity study with taldefgrobep is planned for
2024. Full posters will be available on the Posters and
Presentations page at: www.biohaven.com.
Irfan Qureshi, MD, Chief Medical
Officer at Biohaven, commented, "Together these posters support the
development of taldefgrobep as a novel therapy for the treatment of
overweight and obesity that can result in significant fat loss
while increasing lean mass. This is a paradigm-shift from
traditional obesity therapies that focus on overall weight loss
despite significant difficult to reverse loss in muscle mass."
About Taldefgrobep alfa
Taldefgrobep alfa
(BHV-2000) is a fully human recombinant protein designed to
specifically designed to bind to myostatin (GDF-8) and inhibit the
signaling of both myostatin and activin A, both key regulators of
muscle and adipose tissue. Taldefgrobep binds myostatin. The
myostatin-taldefgrobep complex then acts as an Activin
2a/2b receptor antagonist.
Anti-myostatin therapy has a novel mechanism of action that may
reduce fat mass, increase lean mass, and improve other metabolic
parameters.
About Biohaven
Biohaven is a global clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of life-changing therapies for people with
debilitating neurological and neuropsychiatric diseases, including
rare disorders. Biohaven is advancing a pipeline of best-in-class
therapies for diseases with little or no treatment options,
leveraging its proven drug development capabilities and proprietary
platforms, including Kv7 ion channel modulation for epilepsy and
neuronal hyperexcitability; glutamate modulation for
obsessive-compulsive disorder and spinocerebellar ataxia and
myostatin inhibition for neuromuscular diseases. Biohaven's
portfolio of early- and late-stage product candidates also includes
discovery research programs focused on TRPM3 channel activation for
neuropathic pain and CD-38 antibody recruiting, bispecific
molecules for multiple myeloma. More information about Biohaven is
available at www.biohaven.com.
Forward-looking Statements
This news release includes
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The use of certain words,
including "believe", "may" and "will" and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Biohaven's management about
taldefgrobep alfa as treatment for patients with neuromuscular or
obesity disorders. Investors are cautioned that any forward-looking
statements, including statements regarding the future development,
timing and potential marketing approval and commercialization of
development candidates are not guarantees of future performance or
results and involve substantial risks and uncertainties. Additional
important factors to be considered in connection with
forward-looking statements are described in Biohaven's filings with
the Securities and Exchange Commission, including within the
sections titled "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations". The
forward-looking statements are made as of the date of this new
release, and Biohaven does not undertake any obligation to update
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
Biohaven Contact:
Jennifer
Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
201-248-0741
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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