Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting
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Insights
The successful completion of a Phase 1 clinical trial for DFD-29, with all three primary objectives met and no significant safety issues, is a noteworthy milestone for Journey Medical Corporation. The absence of microbiota suppression or development of resistance is particularly significant given the growing concern over antibiotic resistance. This suggests that DFD-29 could offer a differentiated advantage in the treatment of rosacea, potentially positioning it as a best-in-class option if approved by the FDA.
The implications for Journey Medical are substantial, as the approval of DFD-29 could open up a new revenue stream and strengthen its product portfolio. For stakeholders, the short-term focus will be on the FDA's decision, which could lead to stock volatility. Long-term benefits hinge on the commercial success of the drug, which would depend on its efficacy, safety profile and market acceptance relative to existing treatments.
DFD-29's ability to address both inflammatory lesions and erythema without affecting the skin, GI tract, or vaginal microbiota over a 16-week period is promising. This dual-action treatment approach is relatively rare in rosacea medications, which typically target either pimples or redness but not both. The data presented at the AAD meeting could influence the medical community's perception of DFD-29's therapeutic potential.
From a research perspective, the robustness of the safety data is crucial, as long-term antibiotic use is often associated with concerns about microbiota health. The study's design, which is randomized, double-blind and placebo-controlled, adds credibility to the findings. However, subsequent Phase 2 and Phase 3 trials will be critical to confirm these results and determine the true efficacy of DFD-29.
The treatment landscape for rosacea is competitive, with various topical and systemic therapies available. DFD-29's purported efficacy in treating both inflammatory lesions and erythema could address a significant unmet need in rosacea care. Dermatologists will be interested in the long-term impact of DFD-29 on patients' quality of life and its potential to reduce the need for combination therapies, which can be more complex and costly.
Understanding the impact of DFD-29 on microbiota is also crucial for dermatologists, as the skin microbiome plays a role in the pathogenesis of rosacea. The finding that DFD-29 does not significantly alter the microbiome is reassuring and could be a deciding factor in its prescription. However, it's important to note that Phase 1 trials primarily assess safety and not efficacy, so the dermatological community will await further data before fully endorsing this treatment option.
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 detectable effects on microbiota in the skin, GI tract, or vagina
New Drug Application for DFD-29 currently under review by U.S. FDA
SCOTTSDALE, Ariz., March 11, 2024 (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, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, “We are encouraged by the data presented at the AAD meeting as they demonstrate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. Based on the robust safety and efficacy data seen throughout all of our clinical trials, we believe that DFD-29 has the potential to change the treatment landscape for the millions of patients suffering from rosacea. If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea.”
DFD-29-CD-006 is a multicenter, 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. Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462.
About Rosacea
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 seven branded and two 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 Statements
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,” “potential” 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) 652-4500
ir@jmcderm.com
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FAQ
What were the primary objectives of the DFD-29 Phase 1 clinical trial presented by Journey Medical at the AAD Annual Meeting?
Who presented the data from the Phase 1 clinical trial for DFD-29 at the 2024 American Academy of Dermatology Annual Meeting?
What is DFD-29 being developed for in collaboration with Dr. Reddy's Laboratories Ltd?
How many subjects were enrolled in the DFD-29 Phase 1 clinical trial, and what was the randomization ratio between DFD-29 and placebo?
Where can additional information on the DFD-29 Phase 1 clinical trial be found?
