Journey Medical Corporation An – GuruFocus.com
SCOTTSDALE, Ariz., Aug. 30, 2022 (GLOBE NEWSWIRE) — Journey Medical Corporation (DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of dermatological diseases . conditions, today announced that it has recruited and randomized more than 50% of patients in its Phase 3 clinical program to evaluate the safety, efficacy and tolerability of DFD-29 (minocycline modified release capsules 40 mg) for the treatment of papulo-pustular rosacea. The Phase 3 clinical trials are part of a collaboration with Dr. Reddy’s Laboratories Ltd. for the ongoing development and commercialization of the DFD-29 program.
Claude Maraoui, Co-Founder, President and CEO of Journey Medical, said, “We are very pleased to have enrolled over 50% of patients in our DFD-29 Phase 3 clinical program, an important milestone for Journey Medical. In a Phase 2 multi-center clinical trial, DFD-29 achieved nearly double the efficacy of doxycycline 40 mg capsules on reduction of total inflammatory lesion and treatment success as per Investigator’s Global Assessment (“IGA”). Thus, the data to date suggests the potential of DFD-29 as a more effective treatment option that we hope to offer to the millions of patients worldwide who suffer from rosacea. We look forward to announcing early data in the first half of 2023, with a New Drug Application (“NDA”) filing expected thereafter in the second half of 2023. Upon approval, we expect DFD-29 to achieve Maximum annual net sales over $100 million.
The DFD-29 Phase 3 clinical program consists of two multicenter, randomized, double-blind, parallel-group, active-comparator, placebo-controlled clinical trials, MVOR-01 and MVOR-02 (Minocycline versus Oracea® in Rosacea) , which we plan to support an NDA submission in the United States and potentially a marketing authorization application in Europe. More than 50% of the combined enrollment target of 640 total adult patients with moderate to severe papulopustular rosacea (“PPR”) were enrolled in the trials; one trial is recruiting patients from the United States and the other is recruiting patients from the United States and Europe. The MVOR-01 and MVOR-02 clinical trials are randomized in a 3:3:2 ratio between 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 assess the safety, efficacy and tolerability of DFD-29 versus 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 serious drug-related adverse events have been observed.
Data published in The Journal of Clinical and Aesthetic Dermatology DFD-29 40mg demonstrated significantly superior efficacy to doxycycline 40mg, placebo, and DFD-29 20mg for the treatment of PPR in a Phase 2 clinical study. DFD-29 40mg demonstrated significant statistical versus placebo and doxycycline 40 mg on both primary endpoints – proportion of subjects with IGA treatment success (grade 0 or 1 with at least a two grade reduction from baseline at week 16) and reduction in the total number of inflammatory lesions from baseline to week 16.
Additional information about DFD-29’s Phase 3 clinical trial program is available on ClinicalTrials.gov using identifiers: NCT05296629 and NCT05343455.
Rosacea is a chronic, recurrent, inflammatory skin condition that most commonly manifests with symptoms such as deep facial redness, inflammatory acne-like lesions (papules and pustules) and spider veins (telangiectasia). According to the National Rosacea Society, Rosacea is estimated to affect more than 16 million Americans and up to 415 million worldwide. Rosacea is most common in adults between the ages of 30 and 50. Surveys by the National Rosacea Society report that over 90% of rosacea patients said the condition reduced their self-confidence and self-esteem, and 41% said it caused them to avoid contact. public or to cancel their social engagements. Among rosacea patients with severe symptoms, 88% said the disease had interfered with their work interactions and 51% said they had missed work due to their condition.
Oraycea® and Oraceae® are registered trademarks of Galderma Holdings, SA
About Journey Medical Corporation
Journey Medical Corporation (DERM) (“Journey Medical”) is focused on the identification, acquisition, development and strategic commercialization of innovative and differentiated dermatology products through its effective sales and marketing model. The company currently markets nine branded products and three licensed generic products that help treat and cure common skin conditions. The Journey Medical team includes industry experts with extensive experience developing and marketing some of the most successful prescription brands in dermatology. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the United States Securities and Exchange Commission (“SEC”). For more 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 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Journey Medical. These 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”, “shall”, “could”, “project”, “intend” and similar expressions are generally intended identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could adversely affect our business, results of operations, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, execute and maintain financing and strategic agreements and relationships; risks related to the results of research and development activities; uncertainties related to preclinical and clinical trials; risks relating to the timing of the start and completion of clinical trials, including disruptions that may result from hostilities in Europe; our reliance on third-party vendors; risks related to the COVID-19 outbreak and its potential impact on the ability of our employees and consultants to complete work in a timely manner and our ability to obtain additional financing on favorable terms or not at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulations; patents and intellectual property; competition; the potential recovery of funds lost as a result of previously disclosed cybersecurity breaches; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K filed March 28, 2022, subsequent reports on Form 10-Q, and our other filings that we perform with the SECOND. We expressly disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except where possible. required by law, and we claim safe harbor protection for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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Jaclyn Jaffe and Bill Begien
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