DFD-29 Data Analysis Highlights Efficacy in Rosacea Regardless of Patient Differences in Body Weight

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Journey Medical Corporation recently shared¹ that a new data analysis exploring the efficacy of its FDA-approved² low-dose minocycline formulation DFD-29 (Emrosi) was to be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference.

The data, presented as a poster,³ highlighted the efficacy of DFD-29 in patients with rosacea regardless of body weight.

In 2 pivotal phase 3 clinical trials (MVOR-1 and MVOR-2), researchers evaluated the safety and efficacy of DFD-29 in the treatment of moderate to severe rosacea. Patients were randomized in a 3:3:2 ratio to receive once-daily DFD-29, doxycycline 40 mg, or placebo for 16 weeks, with the primary goal of comparing DFD-29 to placebo in terms of clinical improvement and reduction in inflammatory lesion counts. Secondary endpoints included comparisons to doxycycline.

Together, the studies enrolled 653 participants, predominantly women (more than 75% in both trials), with median baseline body weights of 83.5 kg in MVOR-1 and 83.0 kg in MVOR-2.

Researchers conducted subgroup analyses to assess whether body weight impacted treatment outcomes, dividing participants into those at or below the median body weight (≤MBW) and those above it (>MBW).

Across both studies and body weight subgroups, DFD-29 consistently demonstrated greater treatment success based on Investigator’s Global Assessment (IGA) scores and significantly larger reductions in total inflammatory lesion counts compared to both placebo and doxycycline.

In the ≤MBW group, 75.5% of participants treated with DFD-29 in MVOR-1 achieved IGA success at week 16, compared to 51.0% for doxycycline and 28.2% for placebo. MVOR-2 yielded similar results, with DFD-29 performing more strongly (58.2%) over doxycycline (28.1%) and placebo (29.7%).

Among participants with >MBW, DFD-29 continued to exhibit significant efficacy. IGA success in MVOR-1 was 56.3% for DFD-29 versus 46.9% for doxycycline and 35.3% for placebo, while in MVOR-2, success rates were 65.0%, 33.9%, and 22.6%, respectively.

In the >MBW cohort, DFD-29 led to an average reduction of 22.1 lesions in MVOR-1 and 17.1 in MVOR-2, markedly higher than those observed with doxycycline or placebo.

Safety data showed that DFD-29 was well tolerated across all groups, with adverse event profiles comparable to those of the other treatment arms.

“This analysis demonstrated that Emrosi is body weight independent, which means it can be prescribed without regard to the patient's body weight,” said Julie Harper, MD, in a news release.¹

Harper, who is past president of the American Acne & Rosacea society and Owner of the Dermatology and Skin Care Center of Birmingham, AL, emphasized the data's significance: “This is an important attribute, as it avoids the potential for errors in dose calculations. If doses were to be calculated based on body weight, the wide range of body weights in the real world would pose a challenge.”

Claude Maraoui, co-founder, president, and CEO of Journey Medical Corporation, reiterated the significance of the data, noting that it bolsters DFD-29's position as a standard of treatment in this indication.

“These compelling phase 3 results reinforce the potential of Emrosi to become a new standard of care for patients with rosacea,” Maraoui said.³ “Demonstrating statistically significant and clinically meaningful improvements over both placebo and the current standard of care, regardless of body weight, Emrosi represents a major step forward in managing this chronic and often frustrating skin condition.”

References

1. Journey Medical Corporation announces Emrosi data analysis to be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference. News release. Journal Medical Corporation. June 20, 2025. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2025/06/20/3102695/0/en/Journey-Medical-Corporation-Announces-Emrosi-Data-Analysis-to-be-Presented-at-the-Society-of-Dermatology-Physician-Associates-SDPA-2025-Annual-Summer-Dermatology-Conference.html
2. Journey Medical Corporation announces US FDA approval of Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for the treatment of rosacea. News release. Journey Medical Corporation. November 4, 2024. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2024/11/04/2973917/0/en/Journey-Medical-Corporation-Announces-U-S-FDA-Approval-of-Emrosi-Minocycline-Hydrochloride-Extended-Release-Capsules-40-mg-for-the-Treatment-of-Rosacea.html
3. Efficacy of oral DFD-29, a low-dose minocycline formulation, by body weight in patients with rosacea: an analysis of two phase 3 trials. Poster presented at: Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference; June 26-29, 2025; Washington, DC.

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