Stanford Researchers Presented Results from an Exploratory Study of Serlopitant for the Treatment of Chronic Itch in Epidermo...
May 21 2018 - 8:30AM
Menlo Therapeutics Inc. (NASDAQ:MNLO), a late-stage
biopharmaceutical company focused on the development of serlopitant
for the treatment of pruritus associated with various underlying
dermatologic conditions and for refractory chronic cough, today
announced that data from an exploratory study of serlopitant for
the treatment of chronic itch in epidermolysis bullosa (EB)
patients was presented by a research team from Stanford University
in an oral presentation at the International Investigative
Dermatology meeting on May 18, 2018 in Orlando, Florida.
The exploratory study was conducted
independently by a Stanford University EB research team as an
investigator-sponsored, double-blind, parallel arm,
placebo-controlled, randomized clinical trial evaluating the
comparative effect of serlopitant 5 mg, versus placebo in the
treatment of chronic pruritus in 14 EB patients ages 13 years and
older. Seven patients were treated with serlopitant, and
seven with placebo. This was an exploratory study to determine if
there is any indication that serlopitant may provide benefit to EB
patients by reducing itch. As an exploratory study with only
14 patients, the study was not powered to detect statistically
significant treatment effects at the magnitudes observed in this
trial.
Efficacy at reducing itch was evaluated based
upon a change in Numeric Rating Scale (NRS) itch score from
baseline over the eight-week treatment period. After eight
weeks of treatment, there was a numerically greater decrease in NRS
itch score of 2.1 in the serlopitant treated group versus a
decrease of 1.5 in the placebo treated group (p=0.11).
More patients in the active group (43% vs. 14%) achieved at least a
three-point reduction in NRS itch score by the end of treatment as
compared to placebo.
Serlopitant was well-tolerated in this study
with no new observed safety signals.
“We were pleased to see a greater reduction in
pruritus in the serlopitant arm than in the placebo arm,” said
Albert Chiao, MD, MBA, Clinical Assistant Professor of Dermatology,
Stanford University School of Medicine. “This is an important
finding in EB, as these patients experience significant pruritus,
which has proven very difficult to manage.”
“The findings of this exploratory study in EB
patients further support the potential of serlopitant as a therapy
to reduce pruritus,” said Paul Kwon, MD, Menlo’s Chief Scientific
Officer.
The study was supported by the Epidermolysis
Bullosa Research Partnership and the Epidermolysis Bullosa Medical
Research Foundation.
About Serlopitant
Serlopitant is a once-daily NK1 receptor
antagonist being developed for the treatment of pruritus, or itch,
associated with psoriasis and prurigo nodularis. Serlopitant is
also being evaluated as a potential treatment for refractory
chronic cough, a cough which persists for greater than eight weeks
despite treatment of any identified underlying cause. Menlo
Therapeutics has completed two Phase 2 studies with serlopitant
showing a statistically significant reduction in pruritus compared
to placebo. Originally developed by Merck and licensed to
Menlo Therapeutics in 2012, serlopitant has been evaluated in more
than 1,300 patients and has been shown to be well-tolerated,
including in patients who have received treatment for up to a year.
Serlopitant is an investigational drug that is not currently
approved for use in any indication.
About Epidermolysis Bullosa
EB is a group of rare inherited skin disorders
characterized by skin fragility and blistering. Chronic
pruritus is a lifelong challenge in EB and has been reported to be
the most distressing disease-related symptom. There have been no
new drugs approved for pruritus in EB, and the current management
of pruritus in EB with antihistamines and topical corticosteroids
only minimally relieves itch.
About Menlo Therapeutics
Menlo Therapeutics Inc. is a late-stage
biopharmaceutical company focused on the development of
serlopitant, a once-daily oral NK1 receptor antagonist, for the
treatment of pruritus associated with various underlying
dermatologic conditions and for refractory chronic cough. The
Company’s clinical development program for serlopitant includes
ongoing Phase 2 studies for the treatment of pruritus associated
with psoriasis and refractory chronic cough and ongoing and planned
Phase 3 studies for the treatment of pruritus associated with
prurigo nodularis.
Forward Looking Statements
This press release contains forward-looking
statements, including but not limited to the potential of
serlopitant to treat pruritus associated with epidermolysis
bullosa, psoriasis, and prurigo nodularis, or to treat refractory
chronic cough. Such forward-looking statements involve substantial
risk and uncertainties that could cause Menlo Therapeutics’
development program for serlopitant, future results, achievements
or performance to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, risks that future clinical
trials do not replicate the results from completed clinical trials
or do not demonstrate efficacy of serlopitant in the studied
indications, the risk of adverse safety events, risks that the
costs of clinical trials will exceed expectations, risks that Menlo
Therapeutics will need to raise additional capital, risks of
competition and the risk that Menlo Therapeutics is not able to
successfully defend or protect its intellectual property. For more
information about these and other risks, see Menlo Therapeutics’
quarterly report on Form 10-Q filed with the Securities and
Exchange Commission on May 9, 2018, under the heading “Risk
Factors” and any subsequent current and periodic reports filed with
the Securities and Exchange Commission. Menlo Therapeutics
undertakes no obligation to update these forward-looking
statements.
Media Contact: media@menlotx.com
Investor Contact: dsheel@menlotx.com
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