Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage
biopharmaceutical company focused on the development of serlopitant
for the treatment of pruritus associated with various conditions
and for refractory chronic cough, today announced it has initiated
enrollment in the second of two Phase 3 trials of serlopitant for
the treatment of pruritus with prurigo nodularis (PN). This
second PN Phase 3 trial is being conducted in Europe.
In May, Menlo began enrollment in the first of the two PN Phase
3 trials which is being conducted in the U.S. The U.S. PN
Phase 3 trial is more than 20% enrolled.
Both PN Phase 3 trials are multi-center, randomized,
double-blind, placebo‑controlled trials intended to evaluate if
treatment with 5 mg serlopitant daily for ten weeks can reduce
pruritus associated with PN compared with placebo. Menlo expects to
enroll 200 patients at approximately 50 sites in each trial. The
trials are enrolling patients with a worst‑itch NRS score, or
WI‑NRS, of at least seven at screening. The primary efficacy
analysis for both of these trials is a four‑point responder rate in
the WI‑NRS at ten weeks. Results from both trials are expected in
the first half of 2020.
Completed Phase 2 Clinical Trial of Serlopitant in
Patients with PN
The Phase 2 clinical trial of serlopitant in patients with PN
was completed in June 2016. The study was a multi-center,
randomized, double‑blind, placebo‑controlled study in 127 adult
patients. As previously reported, the study met its primary
and multiple secondary efficacy endpoints of pruritus reduction in
patients in the serlopitant-treatment group compared with placebo.
For the primary efficacy analysis defined as change from baseline
in average itch VAS at weeks four and eight, a serlopitant dose of
5 mg given once a day led to a superior change from baseline in
average itch VAS than placebo. At week four, the serlopitant 5 mg
group showed a 25 mm improvement from baseline in average itch VAS
compared to a 15 mm improvement from baseline in the placebo group
(p = 0.025), and at week eight, the serlopitant 5 mg group showed
an improvement of 36 mm from baseline in average itch VAS compared
with an improvement of 19 mm for the placebo group (p = 0.001).
Patients receiving 5 mg serlopitant had a statistically significant
reduction in the average itch VAS score for pruritus compared to
the placebo group at every measured time point.
Serlopitant has been dosed in approximately 1,400 individuals
and has been shown to be well‑tolerated, including when
administered to patients in a clinical trial for up to one
year.
New Exploratory Analysis of Additional Data from the
Phase 2 Clinical Trial of Serlopitant in PN Presented at the
European Academy of Dermatology and Venereology (EADV)
Congress on September 15th, 2018
A recent exploratory analysis of results from a qualitative
Verbal Rating Scale (VRS) survey instrument given to patients
throughout the completed Phase 2 clinical trial of serlopitant in
patients with PN was presented by Sonja Ständer, M.D., Center for
Chronic Pruritus, Department of Dermatology, University Hospital
Münster, Münster, Germany at the EADV Congress in Paris, France on
Saturday, September 15th. The presentation was based on a
retrospective analysis of the qualitative survey instrument
administered to patients as part of this Phase 2 clinical
trial. The objective of the analysis was to assess the impact
of treatment on sensory sensations of PN experienced by the
patients.
The VRS survey asked patients with respect to pruritus, burning,
and stinging whether such sensations were either not present, mild,
moderate, severe, or very severe. As this was a retrospective
assessment of these data, only descriptive statistical analyses
were conducted. The patient-reported VRS scores indicate
greater improvement in itching, burning and stinging for
serlopitant treated patients as compared to placebo treated
patients.
Characteristic |
Baseline |
After 8 Weeks of Treatment |
|
Placebo-Treated Patients
(n=63) |
Serlopitant-Treated
Patients(n=64) |
Placebo-Treated
Patients(n=63) |
Serlopitant-Treated
Patients(n=64) |
Patients with Moderate, Severe or Very Severe
Pruritus |
96.8% |
|
100% |
|
71.1% |
|
45.6% |
|
Patients with Moderate, Severe or Very Severe
Burning |
64.5% |
|
59.4% |
|
53.5% |
|
26.8% |
|
Patients with Moderate, Severe or Very Severe
Stinging |
45.0% |
|
45.0% |
|
39.5% |
|
22.2% |
|
“Limited data are available about disease characteristics for
patients with prurigo nodularis. The Phase 2 trial of
serlopitant was one of the largest randomized controlled trials
conducted to date in this patient population, and we wanted to
conduct a retrospective analysis to better understand the sensory
experience of patients with PN and the impact of treatment on these
sensations,” said Dr. Sonja Ständer. “The most common
descriptions of pruritus reported by these patients at baseline
were itching, combined with pain-related sensations such as burning
and stinging. In this retrospective analysis, we observed
improvement in some of the most common pruritus characteristics
reported by the patients in this study when treated with
serlopitant for eight weeks.”
About Serlopitant
Serlopitant is a once-daily NK1 receptor antagonist being
developed for the treatment of pruritus, or itch, associated with
various conditions. 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
approximately 1,400 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 Prurigo Nodularis
We estimate that there are approximately 350,000 people with
prurigo nodularis in the United States. Prurigo nodularis is a
chronic skin disorder affecting primarily older adults and is
characterized by multiple, firm, itchy nodules typically found on a
patient’s arms, legs and trunk. Prurigo nodularis results from a
vicious cycle of repeated itching and scratching leading to
formation of raised, inflamed skin nodules that can develop sores
or become hard and crusty. The itching sensation in prurigo
nodularis is extreme and often leads to scratching to the point of
bleeding or pain. No treatment for prurigo nodularis has been
approved in the United States or Europe.
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 conditions and for refractory chronic
cough. The Company’s clinical development program for serlopitant
includes ongoing and planned Phase 3 studies for the treatment of
pruritus associated with prurigo nodularis, ongoing Phase 2 studies
for the treatment of pruritus associated with psoriasis and
refractory chronic cough, and a planned Phase 2 study for the
treatment of chronic pruritus of unknown origin.
Forward-Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Menlo
Therapeutics, they are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the
safe harbor of the Private Securities Reform Act of 1995,
including, but not limited to, statements regarding expectations
about the conduct of a Phase 3 clinical trial in the United States
for pruritus associated with prurigo nodularis and a Phase 3
clinical trial in Europe 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 results, 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 and will be unable to do so on favorable
terms or at all, risks of competition and the risk that Menlo
Therapeutics is not able to successfully defend or protect its
intellectual property. These factors, together with those
that are described in greater detail in Menlo Therapeutics Annual
Report on Form 10-K filed on March 28, 2018 and its Quarterly
Report on Form 10-Q filed on August 1, 2018, as well as any reports
that it may file with the SEC in the future, may cause Menlo
Therapeutics actual results, performance or achievements to differ
materially and adversely from those anticipated or implied by our
forward-looking statements. Menlo Therapeutics undertakes no
obligation to update or revise any forward-looking statements.
Investor Contact: dsheel@menlotx.com
Media Contact: media@menlotx.com
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