Foamix Announces Positive Topline Results from Phase 3 Program Evaluating FMX103 Topical Minocycline Foam for Moderate-to-Severe Papulopustular Rosacea
FMX103 Demonstrated Highly Statistically Significant Improvement Compared with Vehicle in Both Co-Primary Efficacy Endpoints
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“We are very pleased with these top line Phase 3 results of FMX103, which demonstrate that FMX103 can provide a meaningful improvement in disease symptoms and confirm the positive results from previous clinical studies,” said
“This is the second positive Phase 3 outcome for a Foamix product in the past two months, as we also achieved success in our third, confirmatory Phase 3 trial of FMX101 4% minocycline foam for the treatment of moderate-to-severe acne,” continued Mr. Domzalski. “The success of these Phase 3 trials provides further validation for our foam platform and represents the maturing of Foamix’s clinical pipeline.”
FX2016-11 and FX2016-12 Trial Design and Results
These identical, double-blind, randomized, vehicle-controlled Phase 3 studies enrolled a total of 1522 subjects, 18 years of age and older, with moderate-to-severe papulopustular rosacea at 100 sites in
Baseline Papulopustular Rosacea Severity
In study FX2016-11, the mean inflammatory lesion count at baseline was 28.5 and 29.0 for the FMX103 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (“moderate”) or 4 (“severe”) was 89.7% and 10.3%, respectively, in the FMX103 treatment group and 86.7% and 13.3%, respectively, in the vehicle treatment group.
In study FX2016-12, the mean inflammatory lesion count at baseline was 30.0 and 30.2 for the FMX103 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 (“moderate”) or 4 (“severe”) was 86.2% and 13.8%, respectively, in the FMX103 treatment group and 82.9% and 17.1%, respectively, in the vehicle treatment group.
Co-Primary Efficacy Assessments
The following table provides an overview of the efficacy results obtained for both co-primary endpoints for each study. In all cases, FMX103 demonstrated statistically significant improvement in subject disease severity when compared to vehicle foam.
FX2016-11 and FX2016-12 Co-Primary Endpoint Results
|Absolute Change from Baseline in Inflammatory Lesion count at Week 12*||-17.57||-15.65||0.0031||-18.54||-14.88||<0.0001|
|IGA treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline**||52.1%||43.0%||0.027||49.1%||39.0%||0.0077|
*ANCOVA, ITT, MI; **CMH test - stratified by analysis center, ITT, MI
Safety and Tolerability
The most commonly reported adverse event in both studies was upper respiratory tract infection (FX2016-11: 0.8% in the FMX103 treatment group and 2.0% in the vehicle treatment group. FX2016-12: 2.9% in the FMX103 treatment group and 3.1% in the vehicle treatment group). There were no treatment-related serious adverse events. A combined total of 9 subjects discontinued from FX2016-11 and FX2016-12 due to an adverse event (7 in the FMX103 treatment groups and 2 in the vehicle treatment groups). FMX103 appeared to be generally safe and well-tolerated.
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About Papulopustular Rosacea
Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead. It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including LEO Pharma and others.
Foamix uses its website (www.Foamix.com) as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor the Foamix website in addition to following its press releases, filings with the
Forward Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions created by those sections. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S.
Ilan Hadar, CFO
Foamix Pharmaceuticals Ltd.
|U.S. Investor Relations
LifeSci Advisors, LLC
Elizabeth Tang, PhD
LifeSci Public Relations
Source: Foamix, Ltd.