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)
Study demonstrated systemic exposure of DFD-29 was significantly lower than that of Solodyn (105 mg)
Data presented at 43rd Annual Fall Clinical Dermatology Conference
New Drug Application submission to FDA for DFD-29 anticipated in the fourth quarter of 2023
SCOTTSDALE, Ariz., Oct. 20, 2023 (GLOBE NEWSWIRE) — 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.”
Rosacea 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 Corporation
Journey 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.
This 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.
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