Journey Medical Corporation Announces 50% Enrollment Milestone Achieved in Phase 3 Clinical Trials Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Papulopustular Rosacea
August 30 2022 - 8:30AM
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 enrolled and randomized over 50 percent 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. 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 very pleased
to have enrolled over 50 percent of the patients in our DFD-29
Phase 3 clinical program, an important milestone for Journey
Medical. In a Phase 2 multicenter clinical trial, 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. As such, data to date
suggests the potential of DFD-29 as a more effective treatment
option that we hope to provide for the millions of patients
worldwide who suffer with rosacea. We 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.
After approval, we anticipate DFD-29 achieving peak annual net
sales in excess of $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 we expect
to support an NDA submission in the United States and potentially a
Marketing Authorization Application in Europe. Over 50 percent of
the combined enrollment target of 640 total adult patients with
moderate to severe papulopustular rosacea (“PPR”) have been
enrolled in the trials; one trial is enrolling patients in the
United States, and the other is 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 nine branded and
three authorized 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 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 Contacts:Jaclyn Jaffe and Bill
Begien(781) 652-4500ir@jmcderm.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
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