Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a
commercial-stage pharmaceutical company that primarily focuses on
the selling and marketing of FDA-approved prescription
pharmaceutical products for the treatment of dermatological
conditions, today announced positive topline results from the two
Phase 3 multicenter, randomized, double-blind, parallel-group,
active-comparator and placebo-controlled clinical trials,
Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline
Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline
Hydrochloride Modified Release Capsules, 40 mg (“DFD-29”) for the
treatment of moderate-to-severe papulopustular rosacea in adults.
DFD-29 is being developed for the treatment of rosacea in
collaboration with Dr. Reddy’s Laboratories Ltd.
Subjects in the MVOR-1 and MVOR-2 Phase 3
clinical trials were randomized in a 3:3:2 ratio to treatment with
DFD-29, Doxycycline Capsules, 40 mg (“Oracea”) or placebo once
daily for 16 weeks. The primary objective of both studies was to
evaluate the safety and efficacy of DFD-29 compared to placebo for
the treatment of papulopustular rosacea. The secondary objective
was to evaluate the safety and efficacy of DFD-29 compared to
Oracea. Both clinical trials achieved the co-primary and all
secondary endpoints, which compared the efficacy of DFD-29 to
Oracea and placebo for the treatment of rosacea. The proportion of
subjects achieving Investigator’s Global Assessment (“IGA”)
treatment success in the DFD-29 group was statistically superior to
those in Oracea and placebo groups. Additionally, the reduction in
the total inflammatory lesion count from baseline to week 16 in the
DFD-29 group was statistically superior to Oracea and placebo
groups. There were no major safety issues and no serious adverse
events related to study products in both MVOR-1 and MVOR-2 trials.
The number of treatment emergent adverse events (“TEAEs”) and their
severity were similar between the treatment groups. The number of
TEAEs related to study products were also similar between the
groups.
MVOR-1 Topline Results
In the DFD-29 group, 65.0% of subjects
demonstrated IGA success, while 46.1% showed IGA success in the
Oracea group and 31.2% of subjects showed IGA success in the
placebo group. The difference between the DFD-29 and Oracea groups
was statistically significant with a p-value of 0.007, and the
difference between the DFD-29 and the placebo groups was
statistically significant with a p-value of <0.001. The DFD-29
group showed a mean reduction of 21.3 lesions, while the Oracea
group showed a mean reduction of 15.9 lesions, and the placebo
group showed a mean reduction of 12.2 lesions from baseline to week
16. The difference between the DFD-29 and Oracea groups and the
difference between the DFD-29 and placebo groups were statistically
significant, each with a p-value of <0.001.
MVOR-2 Topline Results
In the DFD-29 group, 60.1% of subjects
demonstrated IGA success, while 31.4% showed IGA success in the
Oracea group and 26.8% of subjects showed IGA success in the
placebo group. The difference between the DFD-29 and Oracea groups
was statistically significant with a p-value of <0.001, and the
difference between the DFD-29 and the placebo groups was
statistically significant with a p-value of <0.001. The DFD-29
group showed a mean reduction of 18.4 lesions, while the Oracea
group showed a mean reduction of 14.9 lesions, and the placebo
group showed a mean reduction of 11.1 lesions from baseline to week
16. The difference between the DFD-29 and Oracea groups and the
difference between the DFD-29 and placebo groups were statistically
significant, each with a p-value of <0.001.
Summary Topline Results from MVOR-1 and
MVOR-2
|
MVOR-1 |
MVOR-2 |
IGA Success at Week 16 |
Inflammatory Lesion Change at Week 16 |
IGA Success at Week 16 |
Inflammatory Lesion Change at Week 16 |
DFD-29 (40 mg) |
65.0% |
-21.3 |
60.1% |
-18.4 |
Oracea (40 mg) |
46.1% |
-15.9 |
31.4% |
-14.9 |
Placebo |
31.2% |
-12.2 |
26.8% |
-11.1 |
P-value: DFD-29 versus Oracea |
P=0.007 |
P<0.001 |
P<0.001 |
P<0.001 |
P-value: DFD-29 versus Placebo |
P<0.001 |
P<0.001 |
P<0.001 |
P<0.001 |
Claude Maraoui, Co-Founder, President and Chief
Executive Officer of Journey Medical, stated, “We are very pleased
with the positive results for our two Phase 3 clinical trials
evaluating DFD-29 for the treatment of rosacea, which demonstrated
statistical superiority over both Oracea and placebo. This is a
significant milestone for Journey Medical and potentially the
broader dermatology community. There were approximately 4 million
prescriptions written for rosacea in 2022, according to Symphony
Health Prescription Data. Based on these positive study results, we
plan on submitting a new drug application (“NDA”) for DFD-29 in the
second half of 2023. If approved by the FDA, we believe that DFD-29
has annual peak sales potential of $300 million, globally. With
these clinically meaningful outcomes, DFD-29 has the potential to
be the new treatment paradigm for the millions of patients
suffering from rosacea as the lowest-dose oral minocycline on the
market. The success of this program is a direct result of the
exceptional collaboration between Journey Medical, Dr. Reddy’s, the
Investigators and all others that are involved.”
About the DFD-29 Phase 3 Clinical
ProgramThe DFD-29 Phase 3 clinical program consisted of
two multicenter, randomized, double-blind, parallel-group,
active-comparator and placebo-controlled clinical trials, MVOR-1
and MVOR-2, that are expected to support an NDA submission in the
United States as well as a Marketing Authorization Application in
Europe. The combined enrollment target of 640 adult patients with
moderate-to-severe papulopustular rosacea was achieved in these
trials; MVOR-1 enrolled patients exclusively in the United States,
while MVOR-2 enrolled patients in both the United States and
Europe. Subjects in the MVOR-1 and MVOR-2 trials were randomized in
a 3:3:2 ratio to treatment with DFD-29, Oracea or placebo once
daily for 16 weeks. The primary objective of both studies was to
evaluate the safety and efficacy of DFD-29 compared to placebo for
the treatment of papulopustular rosacea. The secondary objective
was to evaluate the safety and efficacy of DFD-29 compared to
Oracea. Additional information on the DFD-29 Phase 3 clinical trial
program can be found on ClinicalTrials.gov using the identifiers:
NCT05296629 and NCT05343455.
About RosaceaRosacea is a
chronic, relapsing, inflammatory skin condition that most commonly
presents with symptoms such as deep facial redness, acne-like
inflammatory lesions (papules and pustules) and spider veins
(telangiectasia). According to The National Rosacea
Society, it is estimated that rosacea affects well over 16
million Americans and as many as 415 million
worldwide. Rosacea is most frequently seen in adults between
30 and 50 years of age. Surveys conducted by The National
Rosacea Society report more than 90 percent of rosacea
patients said their condition had lowered their self-confidence and
self-esteem, and 41 percent reported that it had caused them to
avoid public contact or cancel social engagements. Among rosacea
patients with severe symptoms, 88 percent said the disorder had
adversely affected their professional interactions, and 51 percent
said they had missed work because of their condition.
Oracea® is a registered trademark of
Galderma Holdings, S.A.
About Journey Medical
CorporationJourney Medical Corporation (Nasdaq: DERM)
(“Journey Medical”) is a commercial-stage pharmaceutical company
that primarily focuses on the selling and marketing of FDA-approved
prescription pharmaceutical products for the treatment of
dermatological conditions through its efficient sales and marketing
model. The company currently markets eight branded and three
generic products that help treat and heal common skin conditions.
The Journey Medical team comprises industry experts with extensive
experience in developing and commercializing some of dermatology’s
most successful prescription brands. Journey Medical is located in
Scottsdale, Arizona and was founded by Fortress Biotech, Inc.
(Nasdaq: FBIO). Journey Medical’s common stock is registered under
the Securities Exchange Act of 1934, as amended, and it files
periodic reports with the U.S. Securities and Exchange Commission
(“SEC”). For additional information about Journey Medical, visit
www.journeymedicalcorp.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
As used below and throughout this press release, the words “the
Company”, “we”, “us” and “our” may refer to Journey Medical. Such
statements include, but are not limited to, any statements relating
to our growth strategy and product development programs and any
other statements that are not historical facts. The words
“anticipate,” “believe,” “estimate,” “may,” “expect,” “will,”
“could,” “project,” “intend” and similar expressions are generally
intended to identify forward-looking statements. Forward-looking
statements are based on management’s current expectations and are
subject to risks and uncertainties that could negatively affect our
business, operating results, financial condition and stock price.
Factors that could cause actual results to differ materially from
those currently anticipated include: the fact that our products and
product candidates are subject to time and cost intensive
regulation and clinical testing and as a result, may never be
successfully developed or commercialized; a substantial portion of
our sales derive from products that may become subject to
third-party generic competition, the introduction of new competitor
products, or an increase in market share of existing competitor
products, any of which could have a significant adverse impact on
our operating income; we operate in a heavily regulated industry,
and we cannot predict the impact that any future legislation or
administrative or executive action may have on our operations; our
revenue is dependent mainly upon sales of our dermatology products
and any setback relating to the sale of such products could impair
our operating results; competition could limit our products’
commercial opportunity and profitability, including competition
from manufacturers of generic versions of our products; the risk
that our products do not achieve broad market acceptance, including
by government and third-party payors; our reliance third parties
for several aspects of our operations; our dependence on our
ability to identify, develop, and acquire or in-license products
and integrate them into our operations, at which we may be
unsuccessful; the dependence of the success of our business,
including our ability to finance our company and generate
additional revenue, on the successful development and regulatory
approval of the DFD-29 product candidate and any future product
candidates that we may develop, in-license or acquire; clinical
drug development is very expensive, time consuming, and uncertain
and our clinical trials may fail to adequately demonstrate the
safety and efficacy of our current or any future product
candidates; our competitors could develop and commercialize
products similar or identical to ours; risks related to the
protection of our intellectual property and our potential inability
to maintain sufficient patent protection for our technology and
products; our business and operations would suffer in the event of
computer system failures, cyber-attacks, or deficiencies in our or
our third parties’ cybersecurity; the substantial doubt about our
ability to continue as a going concern; the effects of major public
health issues, epidemics or pandemics on our product revenues and
any future clinical trials; our potential need to raise additional
capital; Fortress controls a voting majority of our common stock,
which could be detrimental to our other shareholders; as well as
other risks described in Part I, Item 1A, “Risk Factors,” in our
Annual Report on Form 10-K for the year ended December 31, 2022,
subsequent Reports on Form 10-Q, and our other filings we make with
the SEC. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations or any changes in events, conditions or circumstances
on which any such statement is based, except as may be required by
law, and we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Company Contact:Jaclyn Jaffe (781)
652-4500ir@jmcderm.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
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