Superior Results in Foamix's Minocycline Foam Clinical Study: 71% Reduction in Inflammatory Lesions in 6 Weeks

REHOVOT, Israel, June 11, 2013 /PRNewswire/ --

Foamix, a clinical stage specialty pharma company, has announced today the successful completion of its Minocycline foam Phase II clinical trial. The drug was shown to be highly effective in this double blind, dose ranging, placebo controlled study of 150 moderate to severe acne patients. Once daily treatment of Minocycline Foam 4% exhibited an average 71% reduction in inflammatory lesions after 6 weeks with a respective reduction of 55% in non-inflammatory lesions. These extremely positive Minocycline Foam results follow on from those of the Impetigo Study announced in March last year.

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Patients were randomized into three equal groups of 50 patients, who received placebo, or one of two Minocycline Foams - 1% or 4%. Study procedures, criteria and endpoints were based on the current FDA guidance for acne studies.

At the end of the treatment ("EOT") period (12 weeks) of the acne study, the reduction in inflammatory lesions was at 72%, close to its 6 week level, with the reduction in non-inflammatory lesions reaching 73%. The effects were dose-dependent, as demonstrated by the lower effects of the 1% foam and the placebo (Table 1). Table 1 further shows the statistical significance of these results.

Likewise, the Investigator's Global Assessment ("IGA") scores significantly improved during the trial. At the EOT, 53% of the patients had an IGA score of either "Clear" or "Almost clear", while only 20% of the placebo-treated patients had the same scores.

Table 1. Average % reduction in total, inflammatory and non-inflammatory lesion counts after 6 weeks and 12 weeks, and IGA Score Success

                                    Treatment group              P-value
                                                    Placebo
                            Minocycline Minocycline
                              Foam 4%     Foam 1%     (P)   4% vs. P 1% vs. P
    Lesion count % reduction (6 weeks)
    Inflammatory                71%         59%       50%    0.0007   0.1681
    Non-inflammatory            55%         51%       49%    0.3686   0.7966
    Total                       62%         54%       49%    0.0189   0.4303
    Lesion count % reduction (EOT, 12 weeks)
    Inflammatory                72%         67%       51%    0.0001   0.0072
    Non-inflammatory            73%         65%       57%    0.0197   0.1587
    Total                       72%         64%       54%    0.0023   0.0631
    IGA Score "Success" (12
    weeks)*                     53%         37%       20%    0.0010   0.0640

* IGA Score "Success" defined as the IGA score reducing to either "Almost clear" or "Clear" at EOT, 12 weeks.

The study showed a very encouraging safety profile, with very few patients exhibiting mild and transient skin dryness, peeling and/or erythema, who were evenly distributed among the treatment groups. No drug-related systemic adverse events were noted.

Patient satisfaction is of utmost importance. This is especially true for a topical drug, as ease of application will encourage continued use. In the Minocycline-4% group, 61% of patients stated that the efficacy was very high or high, and 27% rated the efficacy as moderate (median efficacy rating in this group was "high," and was "moderate" in the placebo group)". Furthermore, 86% of the patients rated the drug as "very-highly" or "highly" better than other drugs they had formerly used.

As for ease of use of the drug, 98% of all the patients said they were generally satisfied from the ease of use. Patients noted that there was an oily feeling after use; however, 71% rated the overall after-use feeling as very-highly, highly, or moderately satisfactory. In comparison with former topical acne drugs, most of the patients (60%) rated Minocycline Foam as more convenient than other drugs they know.  

In literature comparison, published results of Solodyn® (oral minocycline) and recently-approved topical drugs reveal that the results observed for Minocycline Foam are superior, as shown in Table 2.

Table 2. Literature comparison between the efficacy of Minocycline Foam and the published efficacies of Solodyn®, Epiduo®, Acanya® and Ziana® and the most recently approved acne drug Fabior™*

                                                                       Ziana(R)

                                             Epiduo(R)                (Retinoic    Fabior
                                 Solodyn(R)              Acanya(R)       acid       (TM)
                      Foamix                 (Adapalene                           (Tazaro
                    Minocycline    (Oral                (Clindamycin      +         -tene
                     Foam (4%)  Minocycline)   + BPO)      + BPO)    Clindamycin)   Foam)
    Inflammatory
    lesion count %
    reduction**          72%         44%         47%         55%          54%          57%
    Non-inflammatory
    lesion count %
    reduction**          73%      No effect*     49%         43%          43%          55%
    IGA Score
    "Success"            53%         17%          -          29%          31%          29%

*  Source: Prescription Instruction leaflets of Solodyn®, Epiduo®, Acanya®, Ziana® and Fabior™ (average of Phase III clinical studies, as presented in the "clinical studies" section).

** All studies included 12 weeks of treatment.

Foamix's current Phase II study has shown its Minocycline Foam to be a safe and effective topical treatment and an alternative to oral antibiotics, with superior efficacy and no significant side effects. Moreover, Minocycline Foam may further capture material portions of the market for topical antibiotics, retinoids and combination products.

About Acne

Acne vulgaris is a common human skin disease, characterized by areas of skin with seborrhea, comedones (blackheads and whiteheads), papules, pustules, nodules (large papules) and possibly scarring. The disease occurs most commonly during adolescence, and often continues into adulthood. In adolescence, acne is usually caused by an increase in testosterone, which accrues during puberty, regardless of sex.

Acne is a very common condition, affecting over 80% of individuals at some point in their lives (British Medical Journal. 2006; 333; 949 - 953). Globally acne affects approximately 650 million people or about 9.4% of the population, as of 2010 (Lancet 2012; 380: 2163-96). In the United States acne affects 40 to 50 million people (J. Am. Acad. Dermatol. 39 (2 Pt 3): S34-7).

According to GBI Research report "The Future of Dermatology Therapeutics, Analysis and Market Forecasts to 2016" (2010; pp. 71-83) the global acne market was worth $2.8 billion in 2009; and it is estimated to reach revenues of $3 billion by 2016. 

Moderate to severe acne vulgaris is estimated to affect approximately three to four million people in the U.S. Moderate to severe acne is often treated with orally administered antibiotics, primarily oral minocycline and doxycycline, which both have multiple adverse effects. According to one of the leading data providers, Thomson Reuters, oral minocycline and doxycycline account for over $1.2 billion sales and about 5 million prescriptions annually. In more severe cases, isotretinoin (an oral retinoid drug) treatment may be prescribed, although it is only available through a restricted distribution program due to some of its serious potential side effects.

About Foamix

Foamix is a clinical stage specialty pharmaceutical company. The company's lead product, Minocycline Foam, is the first-ever topical minocycline which can be used for the treatment of acne, rosacea and skin infections. 

Minocycline, a well know broad-spectrum antibiotics, is given today solely in an oral manner, mainly for the treatment of Acne. Foamix believes that topical Minocycline foam will take over a major portion of the current oral anti-acne and anti-rosacea drug market, as it offers high efficacy with a favorable safety profile; and thus, to capture a large and growing market of over 1 billion dollars a year in the US.

To date, Foamix has 16 issued patents in the United States. Additionally, the Company has more than 135 pending patent applications worldwide, of which over 65 applications are filed in the U.S. 

As a technology leader, Foamix collaborates with multinational and local pharmaceutical companies, in the development of patent-protected, unique topical products using its versatile patent protected foam platforms. 

Acknowledgement: The development of Minocycline foam was supported by the BIRD Foundation: http://www.birdf.com

More information about Foamix can be found at http://www.foamix.co.il

Contact:
Dov Tamarkin, CEO
Foamix Ltd.
dov@foamix.co.il

Dorit Hayon, Business Development Manager
Foamix Ltd.
dorit@foamix.co.il

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