Menlo Therapeutics Announces Results from a Phase 2 Trial of Serlopitant for Pruritus Associated with Atopic Dermatitis
April 08 2018 - 6:00PM
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 the treatment of refractory chronic
cough, today announced top-line results from MTI-103 (ATOMIK), the
Phase 2 clinical trial of serlopitant for the treatment of pruritus
in adults and adolescents with a history of atopic dermatitis
(AD). The study did not meet its primary or key secondary
efficacy endpoints with no statistically significant difference
demonstrated between the serlopitant treated groups and the placebo
treated group. Numerical differences favoring the serlopitant
treated group were evident at all timepoints. Serlopitant was
well-tolerated in this study.
Summary Results:
Endpoint |
Placebo |
Serlopitant 1 mg |
Serlopitant 5 mg |
Mean Change from
Baseline |
|
Absolute Change |
Absolute Change |
Treatment Effect(1) |
Absolute Change |
Treatment Effect(1) |
WI-NRS mean change from baseline at week 2 |
-1.13 |
|
-1.42 |
|
-0.29 |
-1.29 |
|
-0.16 |
WI-NRS mean change from baseline at week 4 |
-1.66 |
|
-1.79 |
|
-0.13 |
-1.78 |
|
-0.12 |
WI-NRS change mean from baseline at week 6 (Primary Endpoint) |
-2.01 |
|
-2.32 |
|
-0.32 (p=0.11) |
-2.25 |
|
-0.23 (p=0.17) |
Responder Rate Analysis |
|
Response Rate |
Response Rate |
Treatment Effect(2) |
Response Rate |
Treatment Effect(2) |
NRS ≥ 4-point responder rate at week 6 (Secondary Endpoint) |
16.5 |
% |
22.4 |
% |
5.9% (p=0.09) |
20.6 |
% |
4.2% (p=0.17) |
(1) Treatment effect represents the difference between the
absolute change in the serlopitant treated groups vs. the absolute
change in the placebo treated group.
(2) Treatment effect represents the difference between the
response rate in the serlopitant treated groups vs. the response
rate in the placebo treated group.
“While we are disappointed that the results in this Phase 2
trial of pruritus associated with atopic dermatitis did not reach
statistical significance and did not show the same magnitude of
treatment effect as in our prior pruritus studies, we do see in the
results a pattern that shows numerical improvement in each
serlopitant treatment group above the placebo group at every
timepoint. This is our third pruritus study of serlopitant.
Reduction of pruritus has been demonstrated in two prior
Phase 2 studies, one trial in patients with chronic pruritus and
one trial in patients with prurigo nodularis,” stated Steve Basta,
Chief Executive Officer of Menlo Therapeutics. “We are initiating
Phase 3 studies in prurigo nodularis this quarter, and we are
looking forward to the Phase 2 results in refractory chronic cough
in the fourth quarter of this year, and the Phase 2 results in
pruritus associated with psoriasis by late 2018 or early 2019.”
Serlopitant was well-tolerated in this study. No serious
adverse events were assessed as likely related to serlopitant.
Treatment-emergent adverse events that were assessed as possibly
related to treatment were observed with similar frequency in all
three study groups (9.5% for placebo, 7.5% for 1 mg, and 8.1% for 5
mg). The only treatment emergent adverse events that were
reported in more than 5% of patients in any study group were
worsening of atopic dermatitis (3.2% for placebo, 1.3% for 1 mg,
and 5.6% for 5 mg) and worsening of pruritus (5.1% for placebo,
5.6% for 1 mg, and 1.9% for 5 mg). The consolidated safety
summary for serlopitant now includes more than 1,300 patients that
have been evaluated, including patients who have received treatment
for up to a year.
The ATOMIK, MTI-103 study, was a multi-center, randomized,
placebo-controlled Phase 2 clinical trial conducted at 52 US sites
to assess the efficacy, safety and tolerability of serlopitant. The
study enrolled 484 subjects ages 13 years of age and older with a
past or present diagnosis of atopic dermatitis, pruritus for at
least six weeks, and an average weekly worst-itch numeric rating
scale, or WI-NRS score ≥ 6 for each of the two weeks of the
screening period, as recorded in the eDiary. Patients were
randomized into one of three treatment arms: once-daily doses of
placebo, 1 mg serlopitant, or 5 mg serlopitant. The trial
included a two-week screening period, a six‑week treatment period
and a four‑week follow-up period. This trial was intended to
evaluate if treatment with either 5 mg or 1 mg serlopitant daily
for six weeks could reduce pruritus associated with atopic
dermatitis compared with placebo. The primary efficacy analysis
compared the difference between serlopitant and placebo in the mean
change in WI‑NRS from baseline to week 6. A key secondary endpoint
was a responder-rate analysis of a 4-point WI-NRS improvement at
week 6.
Management will conduct a conference all at 4:00AM PT / 7: 00AM
ET on Monday, April 9, 2018 to discuss the results. The
conference call will be webcast live and can be accessed by logging
on to the “Investors” section of the Menlo Therapeutics website,
www.menlotherapeutics.com, prior to the event. A replay of the
webcast will be archived on the Company’s website for 30 days
following the call.
To participate on the live call, please dial (877) 253-4330
(toll-free) or (706) 643-0896 (toll) and reference conference ID
6191407 prior to the start of the call.
About Serlopitant
Serlopitant is a once-daily NK1 receptor antagonist being
developed for the treatment of pruritus, or itch, associated with
atopic dermatitis, 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 three Phase 2 studies with serlopitant
showing a statistically significant reduction in pruritus compared
to placebo in two of the three studies. 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 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 has a broad clinical
development program for serlopitant including two ongoing Phase 2
studies for the treatment of pruritus associated with psoriasis and
refractory chronic cough and expects to start Phase 3 trials for
the treatment of pruritus associated with prurigo nodularis in the
second quarter of 2018. Menlo Therapeutics has exclusive worldwide
rights to serlopitant, excluding in Japan where Menlo Therapeutics
has licensed exclusive rights to JT Torii.
Forward Looking Statements
This press release contains forward-looking statements,
including but not limited to the potential of serlopitant to treat
pruritus associated with atopic dermatitis, psoriasis, and prurigo
nodularis, or to treat refractory chronic cough, the anticipated
announcement of results of Phase 2 clinical studies for refractory
chronic cough and pruritus associated with psoriasis, and
expectations about the start of Phase 3 clinical trials for
pruritus associated with prurigo nodularis. 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 the timing of
enrollment or commencement of clinical trials may be delayed, the
risk that subsequent 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’ annual report on Form 10-K
filed with the Securities and Exchange Commission on March 28,
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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