Journey Medical Corporation Announces DFD-29 Data Presented at 44th Fall Clinical Dermatology Conference

Rhea-AI Summary

Journey Medical (Nasdaq: DERM) presented data on DFD-29, a minocycline-based treatment for rosacea, at the 44th Fall Clinical Dermatology Conference. The study compared DFD-29 (40mg) with doxycycline (40mg) over 21 days, showing DFD-29 achieved higher dermal concentrations from Day 1. The company's New Drug Application is under FDA review with a PDUFA date of November 4, 2024. The randomized study demonstrated that DFD-29's modified-release formulation maintained consistent plasma levels while providing superior skin penetration compared to doxycycline, with both treatments showing good tolerability.

Positive

• DFD-29 demonstrated superior dermal concentration compared to doxycycline from Day 1
• FDA review of New Drug Application is in progress with clear PDUFA date
• Both treatments showed good tolerability in clinical trials

Negative

• None.

Insights

Medical Research Analyst

The pharmacokinetic data for DFD-29 presents significant potential in the rosacea treatment market. Key findings show superior dermal concentration compared to doxycycline from Day 1, with sustained high levels through Day 21. The modified-release formulation achieves this while maintaining similar plasma levels, suggesting better targeted delivery to the skin.

The upcoming PDUFA date of November 4, 2024 is particularly significant as DFD-29 could become the lowest fixed-dose minocycline treatment available. The market potential is substantial, considering the millions of rosacea patients seeking effective treatment options. The drug's ability to achieve higher skin concentrations while maintaining good tolerability could translate to better clinical outcomes and market acceptance.

The parallel development with Dr. Reddy's Laboratories adds credibility to the manufacturing and commercialization prospects. The positive safety profile and pharmacokinetic advantages position DFD-29 as a potential market leader in rosacea treatment.

Poster Presented on Dermal and Systemic Pharmacokinetics of Oral DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) versus Oral Doxycycline 40 mg Capsules (Oracea®) in Healthy Subjects

With its modified-release formulation, DFD-29 (40 mg) provides higher dermal concentration than doxycycline from Day 1 onward at a similar dose, expected to translate into a clinically meaningful impact for treating patients with rosacea

New Drug Application for DFD-29 under review by FDA with PDUFA goal date of November 4, 2024

SCOTTSDALE, Ariz., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today presented data assessing the dermal and systemic pharmacokinetics (PK) of oral DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) versus oral Doxycycline 40 mg capsules (Oracea®) in healthy subjects at the 44^th Fall Clinical Dermatology Conference that is taking place October 24-27, 2024, in Las Vegas, NV. 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, “Based on the robust safety and efficacy data seen throughout all our clinical trials, we believe DFD-29 can change the treatment landscape for the millions of patients suffering from rosacea. We submitted a New Drug Application to the U.S. Food and Drug Administration for DFD-29 earlier this year and look forward to the upcoming PDUFA date of November 4, 2024. If approved, DFD-29 has the potential to be the lowest fixed-dose minocycline and the best-in-class therapy for rosacea patients.”

This randomized, open-label, single-center, parallel-group study evaluated the systemic and dermal PK of once-daily administration of oral DFD-29 40 mg capsules versus oral doxycycline 40 mg for 21 days in healthy adult volunteers. Plasma PK parameters (Cmax & AUC) were similar on Day 1 and Day 21 for minocycline (DFD-29), but doxycycline showed accumulation in the plasma with a significant increase in PK parameters from Day 1 to Day 21. Mean dermal Cmax and AUC for minocycline (DFD-29) reached maximum levels on Day 1 and remained at a high level until Day 21, while doxycycline started with low levels on Day 1 and attained peak on Day 21. Minocycline (DFD-29) had significantly higher levels than doxycycline in the skin both on Day 1 and Day 21. Both DFD-29 and doxycycline were well tolerated by the healthy volunteers.

Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, said, “With its modified-release formulation, DFD-29 (40 mg) provides higher dermal concentration than a similar dose of doxycycline from Day 1 and onward. These PK data suggest DFD-29 could have a clinically meaningful impact in treating patients with rosacea.”

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, 2023, 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

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com  

FAQ

When is the PDUFA date for Journey Medical's (DERM) DFD-29 rosacea treatment?

The PDUFA date for Journey Medical's DFD-29 rosacea treatment is November 4, 2024.

What are the key findings of Journey Medical's (DERM) DFD-29 clinical trial vs doxycycline?

The study showed DFD-29 (40mg) achieved higher dermal concentrations than doxycycline from Day 1 and maintained consistent plasma levels throughout the 21-day trial period.

What is the dosage of Journey Medical's (DERM) DFD-29 for rosacea treatment?

DFD-29 is formulated as a 40mg modified-release minocycline hydrochloride capsule.