Full Press Release Details
Menlo Therapeutics Announces Positive
2 Trial of FCD105 for the Treatment of Moderate-to-Severe
The Company plans to present trial data
along with a proposed Phase 3
development program in an End of Phase 2 meeting with the FDA before the
BRIDGEWATER, New Jersey, June 02, 2020 -- Menlo Therapeutics
Inc. (Nasdaq: MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing
and commercializing proprietary therapies to address unmet needs in dermatology, today announced positive results from a Phase
2 clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever
topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. Study FX2016-40 enrolled
447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle
foam. The Company has begun preparations to conduct an End of Phase 2 meeting with the FDA before the end of this year.
FCD105 showed a highly statistically significant improvement
compared to vehicle for the endpoints of (1) Investigator's Global Assessment (IGA) treatment success (IGA score "0"
or "1" and at least a two-grade improvement from baseline) and (2) absolute change from baseline in mean inflammatory
counts at Week 12. The proportion of patients achieving IGA treatment success in the FCD105 treatment group was 35.9% compared
to 15.7% of patients in the vehicle treatment group (p=0.0003). Absolute reduction in inflammatory lesion counts at Week 12 was
-19.4 (-64.1%) for the FCD105 treatment group compared to -15.58 (-50.9%) for the vehicle treatment group (p=0.0020).
The trial was not originally powered to demonstrate a statistical
difference between FCD105 and either 3% minocycline foam or 0.3% adapalene foam treatments; however, the majority of these comparisons
did show a statistically significant improvement of FCD105 at Week 12. Numerical improvement was observed for FCD105 on all efficacy
endpoints for these comparisons at Week 12.
Absolute reduction in non-inflammatory lesion counts at Week
12 was also assessed with a mean lesion count reduction of -24.94 (-51.0%) for the FCD105 treatment group compared to -22.87 (-45.9%)
for the vehicle treatment group. Although numerical improvement was shown, this was not statistically significant, which has been
attributed to outlier results affecting both FCD105 and vehicle treatment groups. Conversely, absolute reduction in non-inflammatory
lesion counts at Week 12 for FCD105 did show a statistically significant improvement compared to each of (1) 3% minocycline
foam and (2) 0.3% adapalene foam.
The most commonly reported treatment-emergent adverse event
in the trial was upper respiratory tract infection (4.9% in the vehicle treatment group) with dry skin being the most commonly
reported cutaneous adverse event (3.6% in the 0.3% adapalene treatment group). The majority of adverse events were assessed as
mild in severity. There were no serious adverse events.
FCD105 was comparably tolerated to vehicle in all local skin
tolerability assessments with 93% or greater of severity scores being assessed as "none" or "mild" for
burning/stinging, itching, dryness, scaling, erythema and hyperpigmentation.
"We are pleased with the results of this study. The data
suggests FCD105 has the potential to be a best-in-class treatment for patients with acne and could provide an important new treatment
option for this challenging condition," said Dr. Iain Stuart, Chief Scientific Officer of Menlo. "We look forward to
engaging with the FDA on these data and our plans for the Phase 3 program."
About Study FX2016-40
Study FX2016-40 is a prospective, randomized, double-blind,
vehicle-controlled Phase 2 trial that enrolled patients aged 12 years and older with a clinical diagnosis of moderate-to-severe
acne vulgaris. Patients were randomized to one of four treatment arms: FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or
vehicle foam and self-applied their assigned treatment once daily for 12 weeks. The primary efficacy endpoints were: (1) the proportion
of patients achieving treatment success at Week 12 based on an Investigator's Global Assessment (success is defined as a score
of 0 "clear" or 1 "minimal" and at least a two-grade improvement from baseline), (2) the mean change from baseline
in inflammatory lesion counts in each treatment group at Week 12, and (3) the mean change from baseline in non-inflammatory lesion
counts in each treatment group at Week 12. Safety evaluations include reported adverse events, local skin tolerability assessments,
physical examinations and vital signs.
Acne is a chronic, inflammatory skin condition that affects
the skin's oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory
lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to
50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that significantly impacts
self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However,
some individuals, particularly women, can experience acne much later in life.
FCD105 is Menlo's proprietary 3% minocycline, 0.3% adapalene
combination foam formulation intended for the treatment of moderate-to-severe acne vulgaris. FCD105 combines the bacteriostatic
and anti-inflammatory properties of minocycline with the third-generation retinoid, adapalene, which acts in regulating the differentiation
of follicular epithelial cells. Oral minocycline and topical adapalene products are approved for use in the treatment of acne vulgaris
in the United States, with the latter available in combination and as monotherapy. Pending a successful development program,
the FCD105 new drug application is intended to be filed under the FDA's 505(b)(2) regulatory pathway.
Menlo Therapeutics Inc. recently combined
with Foamix Pharmaceuticals Ltd. to form a different type of biopharmaceutical company working to solve some of today's
most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard,
the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology
(MST ), and has received FDA approval for AMZEEQ (minocycline) topical foam, 4%, the world's first topical minocycline,
and now also for ZILXI (minocycline) topical foam, 1.5%, the first
minocycline product of any kind to be approved by the FDA for use in rosacea.
For more information about Menlo or its investigational products,
visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Menlo's website in addition to following its press releases, filings with the U.S.
Securities and Exchange Commission, public conference calls, and webcasts.
Cautionary Statement Regarding Forward-Looking Statements
release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including,
but not limited to, statements regarding expectations with respect to the financial results of Menlo and statements regarding
the development and commercialization of Menlo's products and product candidates and other statements regarding the future
expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking
statements. Any forward-looking statements are based on Menlo's current knowledge and its present beliefs and expectations
regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ
materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include,
but are not limited to the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization
of our products; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that
results from Menlo's clinical trials are not sufficient to support registration or marketing approval of product candidates;
the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products
or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional
requirements before approving AMZEEQ or ZILXI prescription reimbursement; the eligible patient base and commercial potential of
AMZEEQ, ZILXI or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights,
such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted
narrowly or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable
or one or more of Menlo's patent applications may not be granted and potential competitors may also seek to design around
Menlo's granted patents or patent applications; additional competition in the acne and dermatology markets; risks related
to our indebtedness; inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and
retain key employees; and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion
of other risks and uncertainties, and other important factors, any of which could cause Menlo's actual results to differ
from those contained in the forward-looking statements, see the section titled "Risk Factors" in Menlo's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other
important factors in Menlo's subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes
these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation
to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required