Foamix Announces Additional Positive Topline Results from Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam for Moderate-to-Severe Acne
- Statistically significant improvement demonstrated in reduction of non-inflammatory lesions
- Dermal tolerability scores consistent with previous Phase 3 studies
- Re-analysis including patients from discontinued investigator site consistent with primary ITT analysis for both co-primary endpoints, reflecting highly statistically significant results
Key Secondary Efficacy Assessments
- Significant reduction in the number of non-inflammatory lesions
The mean reduction in non-inflammatory lesion count at Week 12 relative to Baseline was -18.83 for the FMX101 treatment group and -15.67 for the vehicle treatment group (p=0.0080, ANCOVA, ITT, MI).
- Percent change in inflammatory lesion count at Week 3, 6, 9 and 12
At Week 12, the percent change in inflammatory lesion count was -56% for the FMX101 treatment group and -43% for the vehicle treatment group (p<0.0001). A statistically significant difference in percent reduction in inflammatory lesion count between treatment groups was also observed at week 3, 6, and 9 [all assessed timepoints] (p<0.0001).
During the study, quality issues were identified at one clinical site requiring discontinuation of the site from the study and removal of corresponding subject data from the intent-to-treat population (19 enrolled subjects). Supplemental re-analysis of both co-primary endpoints including data from these subjects demonstrated comparable results to the primary analyses with equally high statistical significance between the treatment groups (p<0.0001 for both analyses).
Safety and Tolerability – Dermal Tolerability
Dermal tolerability was assessed by scoring the severity of itching, skin peeling, erythema, hyperpigmentation and dryness on a scale of 0 to 3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. These assessments were made at study weeks 3, 6, 9 and 12.
At Week 12, greater than 95% of scores were 0 (none) or 1 (mild). These tolerability scores were comparable with the equivalent assessments made in the Company’s earlier phase 3 studies (FX2014-04 and FX2014-05).
“The data from this confirmatory Phase 3 study are impressive, and the reductions in inflammatory lesions and proportion of patients achieving clinical success appear consistent with prior studies of FMX101, including Study 05,” stated
|Date:||Tuesday, October 2|
|Time:||12:15pm Eastern Time|
|Location:||InterContinental New York Barclay Hotel|
Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that significantly impacts self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
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, as assignee to our license with Bayer, 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.
|Contact:||U.S. Investor Relations|
|Ilan Hadar, CFO||Michael Rice|
|Foamix Pharmaceuticals Ltd.||LifeSci Advisors, LLC|
|Elizabeth Tang, PhD|
|LifeSci Public Relations|
Source: Foamix, Ltd.