REHOVOT, Israel and BRIDGEWATER, N.J., Feb. 18, 2020 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) ("Foamix" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced results from an integrated efficacy analysis on the two pivotal Phase 3 clinical trials for FMX103 (minocycline, 1.5% foam) currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe papulopustular rosacea in adults. The new data have been presented at the 17th Annual South Beach Symposium in Dermatology held on February 6-9, 2020 in Miami, Florida.
Foamix previously announced that the FDA has accepted the filing of a New Drug Application for FMX103 for the treatment of moderate to severe papulopustular rosacea in adults with the action date set for June 2nd, 2020 under the Prescription Drug User Fee Act (PDUFA).
Integrated Summary of Efficacy Highlights:
- The integrated efficacy analysis compared FMX103 to vehicle from 2 identical Phase 3 studies (FX2016-11 and FX2016-12) with 1,522 subjects (1,009 subjects received FMX103 and 513 subjects received vehicle) after 12 weeks of once daily application.
- In the combined analysis of both pivotal Phase 3 studies, FMX103 demonstrated statistically significant benefit compared to vehicle foam on both co-primary endpoints
- Significantly greater reduction of inflammatory lesion counts from Baseline to Week 12 for FMX103 compared to vehicle (-18.0 vs. -14.9; p<0.001), respectively.
- Significantly greater number of subjects receiving FMX103 achieved IGA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at Week 12, (50.6% vs. 41.0%; p<0.001), respectively.
- Statistical superiority of FMX103 when compared to vehicle was observed for both co-primary endpoints for all supporting sensitivity analyses.
- In a subgroup analysis of disease severity, FMX103 demonstrated statistically significant efficacy over vehicle in both Baseline severity groups: IGA 3 ("moderate") and IGA 4 ("severe").
- For subjects assessed as having severe papulopustular rosacea (IGA 4) at Baseline in each study:
- The FMX103 integrated treatment group demonstrated a significantly higher reduction of inflammatory lesions compared to the vehicle integrated treatment group from Baseline to Week 12, (-26.0 vs. -15.1; p<0.001), respectively.
- The FMX103 integrated treatment group demonstrated a significantly higher proportion of subjects achieving IGA treatment success compared to the vehicle integrated treatment group at Week 12, (36.8% vs. 14.9%; p=0.003), respectively.
- The integrated efficacy analysis further demonstrated the effect of FMX103 treatment on disease improvement as early as week 4.
About South Beach Symposium
Since 2002, South Beach Symposium has served as a central and comprehensive forum for advanced clinical and aesthetic dermatology education. In its mission to advance new standards of dermatological care, South Beach Symposium has emerged as a leading educational source for the latest therapies, technologies, procedures, and practice guidelines in clinical and aesthetic medicine. With a dual focus on both clinical and aesthetic dermatology, SBS has championed and disseminated a transformative approach to effectively address growing demands for dermatological care. https://www.southbeachsymposium.org/about-us.html
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 the United States (JAAD (2015) 72:749-758). There is no known cure for rosacea. Mild papulopustular rosacea is treated by topical antimicrobials (metronidazole, clindamycin and ivermectin), azelaic acid or retinoids, while the mainstay for the treatment of moderate to severe papulopustular rosacea are oral antibiotics such as doxycycline and, less frequently, tetracycline and off-label use of oral minocycline (Drugs (2014) 74:1457-1465).
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world's first topical minocycline, AMZEEQ. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company's dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne.
Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what's possible for conditions with high unmet needs.
Foamix uses its website 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 Foamix's website in addition to following its press releases, filings with the Securities and Exchange Commission, public conference calls, and webcasts. For more information, visit www.foamix.com.
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release which are not historical facts are forward-looking statements, including, but not limited to, statements regarding the future expectations, plans and prospects for Foamix; the Company's future development plans regarding FMX103, the potential approval of FMX103 by the FDA and the potential for FMX103 to address a significant unmet need. Forward-looking statements are based on Foamix's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, determination by the FDA that results from clinical trials are not sufficient to support registration or marketing approval of our product candidates; the risk that our product candidates will not be successfully developed, approved or commercialized; unexpected delays in clinical trials or announcement of results; our ability to effectively and timely conduct clinical trials in light of excess costs or unfavorable results of clinical trials; delays or denial in the U.S. regulatory approval process and the risks that the current or planned clinical trials will be insufficient to support future regulatory submissions or to support marketing approval in the United States of our product candidates; additional competition in the acne, rosacea and dermatology markets; risks associated with denial of reimbursement by third party payors; our ability to raise additional capital; and our ability to recruit and retain key employees. Foamix discusses many of these risks in greater detail in its periodic filings with the SEC, including under the heading "Risk Factors" in its most recent annual report and subsequent quarterly reports. Although Foamix believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
Ilan Hadar, CFO
Foamix Pharmaceuticals Ltd.
U.S. Investor Relations:
LifeSci Advisors, LLC
SOURCE Foamix Pharmaceuticals Ltd.