Journey Medical Corporation Completes Enrollment in Phase 3 Clinical Trials Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Papulopustular Rosacea
January 10 2023 - 08:30AM
Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a
commercial-stage biopharmaceutical company that focuses on the
development and commercialization of pharmaceutical products for
the treatment of dermatological conditions, today announced that it
has fully enrolled and randomized all of the patients in its Phase
3 clinical program to assess the safety, efficacy and tolerability
of DFD-29 (Minocycline Modified Release Capsules 40 mg) for the
treatment of papulopustular rosacea (“PPR”). The Phase 3 clinical
trials are part of a collaboration with Dr. Reddy’s Laboratories
Ltd. for the ongoing development and commercialization of the
DFD-29 program.
Claude Maraoui, Co-Founder, President and Chief
Executive Officer of Journey Medical, stated, “We are thrilled to
have completed enrollment in our two DFD-29 Phase 3 clinical trials
and look forward to announcing topline data in the first half of
2023, with a New Drug Application (“NDA”) filing subsequently
expected in the second half of 2023. We are extremely grateful to
the patients, physicians and their research teams participating in
these clinical trials, as they are essential to the development of
a new treatment option for the millions of patients worldwide who
suffer with rosacea. Data from the Phase 2 multicenter clinical
trial demonstrated that DFD-29 achieved nearly double the efficacy
compared to doxycycline capsules 40 mg on reducing total
inflammatory lesions and Investigator’s Global Assessment (“IGA”)
treatment success, suggesting the potential of DFD-29 as a more
effective treatment option for rosacea. After approval, we
anticipate DFD-29 achieving peak annual net sales exceeding $100
million.”
The DFD-29 Phase 3 clinical program consists of
two multicenter, randomized, double-blind, parallel-group,
active-comparator and placebo-controlled clinical trials, MVOR-01
and MVOR-02 (Minocycline versus Oracea® in Rosacea), that are
expected to support an NDA submission in the United States and
potentially a Marketing Authorization Application in Europe. The
combined enrollment target of 640 total adult patients with
moderate to severe PPR was achieved in the trials; one trial was
enrolling patients in the United States, and the other was
enrolling patients in both the United States and Europe. The
MVOR-01 and MVOR-02 clinical trials are randomized in a 3:3:2 ratio
to DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40
mg), Oracea® (Doxycycline capsules 40 mg) or placebo once daily for
16 weeks. The primary objective is to evaluate the safety, efficacy
and tolerability of DFD-29 compared to placebo for the treatment of
PPR. The secondary objective is to evaluate the safety, efficacy
and tolerability of DFD-29 compared to Oracea® (Doxycycline
capsules 40 mg). To date, no major safety issues have been
reported, and no drug-related serious adverse events have been
observed.
Data published in The Journal of Clinical and
Aesthetic Dermatology determined DFD-29 40 mg demonstrated
significantly greater efficacy than doxycycline 40 mg, placebo and
DFD-29 20 mg for the treatment of PPR in a Phase 2 clinical study.
DFD-29 40 mg demonstrated statistical significance compared to both
placebo and doxycycline 40 mg on both co-primary
endpoints—proportion of subjects with IGA treatment success (grade
0 or 1 with at least a two-grade reduction from baseline at week
16) and total inflammatory lesion count reduction from baseline to
week 16.
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.
Oraycea® and Oracea® are registered
trademarks of Galderma Holdings, S.A.
About Journey Medical
CorporationJourney Medical Corporation (NASDAQ: DERM)
(“Journey Medical”) is focused on identifying, acquiring,
developing and strategically commercializing innovative,
differentiated dermatology products through its efficient sales and
marketing model. The company currently markets eight 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 and Section
21E of the Securities Exchange Act of 1934, as amended. As used
below and throughout this press release, the words “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: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; uncertainties
relating to preclinical and clinical testing; risks relating to the
timing of starting and completing clinical trials, including
disruptions that may result from hostilities in Europe; our
dependence on third-party suppliers; risks relating to the COVID-19
outbreak and its potential impact on our employees’ and
consultants’ ability to complete work in a timely manner and on our
ability to obtain additional financing on favorable terms or at
all; our ability to attract, integrate and retain key personnel;
the early stage of products under development; our need for
substantial additional funds; government regulation; patent and
intellectual property matters; competition; potential recovery of
funds lost from previously disclosed cyber security breaches; as
well as other risks described in Part I, Item 1A, “Risk Factors,”
in our Annual Report on Form 10-K filed on March 28, 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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