The Phase 3 clinical trials achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues
DFD-29 demonstrated statistical superiority over both Oracea®(doxycycline) capsules and placebo for IGA treatment success in both studies
DFD-29 demonstrated statistical superiority over both Oracea® and placebo for the reduction in the total inflammatory lesion count in both studies
SCOTTSDALE, Ariz., July 11, 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 results from the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg (“DFD-29”) for the treatment of moderate-to-severe papulopustular rosacea in adults. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
Subjects in the MVOR-1 and MVOR-2 Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Doxycycline Capsules, 40 mg (“Oracea”) or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD-29 to Oracea and placebo for the treatment of rosacea. The proportion of subjects achieving Investigator’s Global Assessment (“IGA”) treatment success in the DFD-29 group was statistically superior to those in Oracea and placebo groups. Additionally, the reduction in the total inflammatory lesion count from baseline to week 16 in the DFD-29 group was statistically superior to Oracea and placebo groups. There were no major safety issues and no serious adverse events related to study products in both MVOR-1 and MVOR-2 trials. The number of treatment emergent adverse events (“TEAEs”) and their severity were similar between the treatment groups. The number of TEAEs related to study products were also similar between the groups.
MVOR-1 Topline Results
In the DFD-29 group, 65.0% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.007, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 21.3 lesions, while the Oracea group showed a mean reduction of 15.9 lesions, and the placebo group showed a mean reduction of 12.2 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001.
MVOR-2 Topline Results
In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 18.4 lesions, while the Oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001.
Summary Topline Results from MVOR-1 and MVOR-2
|IGA Success at Week 16||Inflammatory Lesion Change at Week 16||IGA Success at Week 16||Inflammatory Lesion Change at Week 16|
|DFD-29 (40 mg)||65.0%||-21.3||60.1%||-18.4|
|Oracea (40 mg)||46.1%||-15.9||31.4%||-14.9|
|P-value: DFD-29 versus Oracea||P=0.007||P<0.001||P<0.001||P<0.001|
|P-value: DFD-29 versus Placebo||P<0.001||P<0.001||P<0.001||P<0.001|
Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We are very pleased with the positive results for our two Phase 3 clinical trials evaluating DFD-29 for the treatment of rosacea, which demonstrated statistical superiority over both Oracea and placebo. This is a significant milestone for Journey Medical and potentially the broader dermatology community. There were approximately 4 million prescriptions written for rosacea in 2022, according to Symphony Health Prescription Data. Based on these positive study results, we plan on submitting a new drug application (“NDA”) for DFD-29 in the second half of 2023. If approved by the FDA, we believe that DFD-29 has annual peak sales potential of $300 million, globally. With these clinically meaningful outcomes, DFD-29 has the potential to be the new treatment paradigm for the millions of patients suffering from rosacea as the lowest-dose oral minocycline on the market. The success of this program is a direct result of the exceptional collaboration between Journey Medical, Dr. Reddy’s, the Investigators and all others that are involved.”
About the DFD-29 Phase 3 Clinical Program
The DFD-29 Phase 3 clinical program consisted of two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, MVOR-1 and MVOR-2, that are expected to support an NDA submission in the United States as well as a Marketing Authorization Application in Europe. The combined enrollment target of 640 adult patients with moderate-to-severe papulopustular rosacea was achieved in these trials; MVOR-1 enrolled patients exclusively in the United States, while MVOR-2 enrolled patients in both the United States and Europe. Subjects in the MVOR-1 and MVOR-2 trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Oracea or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Additional information on the DFD-29 Phase 3 clinical trial program can be found on ClinicalTrials.gov using the identifiers: NCT05296629 and NCT05343455.
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.
Oracea® is a registered trademark 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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