Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg)
October 20 2023 - 8:30AM
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 data from a comparative bioavailability
(bridging) study of DFD-29 (Minocycline Hydrochloride Modified
Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride
Extended-Release Tablets, 105 mg). DFD-29 is being developed for
the treatment of rosacea in collaboration with Dr. Reddy’s
Laboratories Ltd. The data were presented at the 43rd Annual Fall
Clinical Dermatology Conference taking place in Las Vegas, NV.
“The results of this bioavailability study
successfully demonstrate that the systemic exposure of minocycline
with DFD-29 (40 mg) was significantly lower than that of Solodyn
(105 mg),” said Srinivas Sidgiddi, M.D., Vice President, Research
& Development of Journey Medical. “We’re also encouraged by
DFD-29’s safety profile demonstrated throughout our ongoing
development program.”
The single-center, randomized, open-label,
laboratory-blinded, three-way, six-sequence crossover study
enrolled 24 healthy subjects with three objectives: 1) to assess
the comparative bioavailability of DFD-29 vs. Solodyn (105 mg), 2)
to evaluate the impact of food on DFD-29 bioavailability and 3) to
evaluate the safety and tolerability profile of DFD-29. The mean
age of the subjects was 42.4 years, 87% male (n=20), 78.3%
Caucasian (n=18) and 78.3% were not Hispanic or Latino (n=18).
The study compared the pharmacokinetics of a
single dose of: 1) DFD-29 after an overnight fast of ≥10.5 hours;
2) DFD-29 after an overnight fast of ≥10.5 hours and 30 minutes
after the start of a high-fat, high-calorie breakfast; and 3)
Solodyn (105 mg) after an overnight fast of ≥10.5 hours.
Data highlights include:
- Bioavailability of minocycline was
significantly lower after a single dose of DFD-29 under fasting and
fed conditions vs. Solodyn (105 mg) following a single dose under
fasting conditions.
- Food intake had no impact on
maximum concentration (Cmax) of minocycline from DFD-29 but may
delay absorption and may slightly increase exposure (AUC).
- Treatment-emergent adverse events
were mostly mild (21/22; 95.5%), the most common being headache. No
serious adverse events were reported in the study.
Claude Maraoui, Co-Founder, President and Chief
Executive Officer of Journey Medical, stated, “We continue to be
encouraged by the growing body of clinical research evaluating
DFD-29. Given the previously reported positive results from our two
Phase 3 clinical trials of DFD-29, we anticipate submitting a New
Drug Application to the FDA by the end of this year. If approved,
DFD-29 will be the lowest-dose minocycline on the market and may
create a paradigm shift in how rosacea is treated in the millions
of patients suffering from this condition.”
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.
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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