Journey Medical Corporation Announces Positive Topline Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adult Subjects
Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues
Results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance
Topline data from Phase 3 clinical trials are anticipated in June 2023; New Drug Application filing subsequently expected in the second half of 2023
SCOTTSDALE, Ariz., June 13, 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 positive topline data from the Phase 1 clinical trial assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults. The clinical trial also assessed 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. The study achieved all primary objectives and no significant safety issues were noted during the study. Treatment with DFD-29 for 16 weeks did not produce significant negative impact on the normal microbial flora and did not induce significant bacterial resistance. Additionally, treatment with DFD-29 did not cause significant proliferation of opportunistic organisms. The results indicate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. 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, “We are very pleased with the topline results of this Phase 1 clinical trial, indicating that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. Additionally, we anticipate topline data from the Phase 3 clinical trials in June, with a New Drug Application filing subsequently expected in the second half of 2023. If approved, DFD-29 could provide a new treatment option for the millions of patients suffering from rosacea.”
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 (Minocycline versus Oracea® in Rosacea-1) and MVOR-2 (Minocycline versus Oracea® in Rosacea-2), 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 enrolled patients in the United States, and the other enrolled 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.
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.
Oraycea® and Oracea® are registered trademarks of Galderma Holdings, S.A.
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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Released June 13, 2023