Journey Medical Corporation Announces Positive Comparative Pharmacokinetic (PK) Data for DFD-29
December 20 2022 - 8:30AM
Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a
commercial-stage biopharmaceutical company focused on the
development and commercialization of pharmaceutical products for
the treatment of dermatological conditions, today announced
positive PK comparability data of DFD-29 and key updates on the
progress of its pivotal, Phase 3 clinical study of DFD-29 for the
treatment of papulopustular rosacea in collaboration with Dr.
Reddy’s Laboratories Ltd. (“Dr. Reddy’s”).
The PK study was designed as a single-center,
randomized, open-label, single-dose, three-treatment, crossover,
comparative bioavailability study of Journey Medical’s DFD-29
(Minocycline Modified Release Capsules 40 mg) versus SOLODYN®
(Minocycline Modified Release Tablets 105 mg). A total of 24
healthy adult volunteers were enrolled and examined for up to 30
days. The primary objectives of the study were to assess: 1) the
comparative bioavailability of DFD-29 (Minocycline MR Capsules 40
mg) with SOLODYN® (Minocycline MR Tablets 105 mg) following a
single oral dose administration under fasting conditions in healthy
adult human subjects; and 2) the effect of food on the
bioavailability of DFD-29 (Minocycline MR Capsules 40 mg). The
secondary objective of the study was to evaluate and compare the
safety and tolerability profiles of each study treatment. The study
successfully demonstrated that the systemic exposure of DFD-29 (40
mg) was significantly lower than that of SOLODYN (105 mg).
Additionally, the study showed that food did not have a significant
effect on the pharmacokinetics of DFD-29.
Claude Maraoui, Co-Founder, President and Chief
Executive Officer of Journey Medical, stated, “We are pleased to
continue advancing the DFD-29 clinical program as part of our
collaboration with Dr. Reddy’s. The PK data indicate the safety of
DFD-29 is on par with SOLODYN. To date, the enrollment of our
pivotal, Phase 3 program has reached 96 percent. We look forward to
providing further updates on the DFD-29 program including potential
topline data from the Phase 3 studies, anticipated in the first
half of 2023. Journey Medical also plans to file a New Drug
Application (“NDA”) in the second half of 2023. We hope to show the
potential of DFD-29 as an effective treatment option for the
millions of patients worldwide who suffer with rosacea.”
Additional information on this DFD-29 study can
be found on ClinicalTrials.gov using the identifier:
NCT05452785.
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 is comprised of industry experts with extensive experience
commercializing some of the most successful prescription
dermatology 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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