Foamix Pharmaceuticals Ltd (FOMX)

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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


REHOVOT, Israel and BRIDGEWATER, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced additional topline results from its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne. As the company previously communicated, the study met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment ("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. Results from both co-primary endpoints demonstrated highly statistically significant results for FMX101 vs vehicle, with p-values <0.0001. The safety profile of FMX101 was consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05). Additional study results and analysis are as follows:

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 Edward Lain, MD MBA, Chief Medical Officer, Sanova Dermatology and Principal Investigator in Study FX2017-22. "The treatment benefits of oral antibiotics, including minocycline, have been well documented in moderate-to-severe acne but their use is limited by systemic side effects, which can be serious. The strong body of clinical data on FMX101, including the results from this most recent Phase 3 trial, suggest that it may offer patients an efficacious treatment in a convenient and safe topical foam formulation. I believe that, if approved, it has the potential to address a significant unmet need in this difficult to treat condition."

David Domzalski, CEO of Foamix, will present these study results along with an overall corporate update at the Cantor Fitzgerald Global Healthcare Conference tomorrow, October 2nd at 12:15pm Eastern Time. Updated presentation materials are available on the company's website under "Investors - Events and Presentations" at www.foamix.com.

Cantor Fitzgerald Global Healthcare Conference 2018
Date: Tuesday, October 2
Time: 12:15pm Eastern Time

Location: InterContinental New York Barclay Hotel
Webcast: http://wsw.com/webcast/cantor7/fomx/