Journey Medical Corporation Announces Completion of Treatment Assessing Impact of DFD-29 (Minocycline Modified Release Capsules 40 mg) on Microbial Flora in a Separate Phase 1 Clinical Trial
16 March 2023 - 11:30PM
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
completion of treatment in the Phase 1 clinical trial assessing the
impact of DFD-29 (Minocycline Modified Release Capsules 40 mg) on
the microbial flora of healthy adults. The clinical trial is also
assessing the safety and tolerability of the treatment. DFD-29 is
being developed for the treatment of papulopustular rosacea (“PPR”)
in collaboration with Dr. Reddy’s Laboratories Ltd.
DFD-29-CD-006 is a multi-center,
randomized, double-blind, placebo-controlled, parallel
group study that enrolled 60 healthy, adult subjects (30 males
and 30 females) in a 2:1 randomization between DFD-29 and placebo.
Treatment was administered once daily orally over 16 weeks.
Microbiological samples were collected from the skin (forehead),
stool and vagina at multiple timepoints through the study. No
significant safety issues were noted during the study. Additional
information on the DFD-29 Phase 1 clinical trial can be found on
ClinicalTrials.gov using the identifier: NCT05597462.
Claude Maraoui, Co-Founder, President and Chief
Executive Officer of Journey Medical, stated, “DFD-29 continues to
make positive progress in the clinic, bringing us closer to
potentially providing a new treatment option for the millions of
patients suffering from rosacea. We expect to report topline
results from the Phase 1 trial in the first half of 2023. In
addition, we are pleased that the DFD-29 Phase 3 clinical trials
have been fully enrolled as of January 2023. We anticipate topline
data from the Phase 3 clinical trials in the first half of 2023,
with a New Drug Application filing subsequently expected in the
second half of 2023.”
The DFD-29 Phase 3 clinical program consists of
two multicenter, randomized, double-blind, parallel-group,
active-comparator and placebo-controlled clinical trials, MVOR-1
and MVOR-2 (Minocycline versus Oracea® in Rosacea), that are
expected to support a New Drug Application (NDA) submission in the
United States and 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-1
and MVOR-2 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.
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; 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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