- Minocycline Systemic Bioavailability For FMX-101 Was More Than 100 Times Lower Than That For Solodyn.
- FMX-101 Was Well-Tolerated.
REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 07, 2016 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) (“Foamix”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced positive results from a Phase 1 maximum use (“MUSE”) pharmacokinetics study of FMX-101 (a topical foam containing 4% minocycline), which is in development for the treatment of moderate-to-severe acne.
This Phase 1 study was intended to characterize the systemic absorption of minocycline after repeated maximum dose applications of FMX-101 in subjects with moderate-to-severe acne and, by so doing, to provide a clinical bridge to minocycline systemic safety data known to the FDA.
The objectives of the study were:
- To characterize minocycline pharmacokinetics following multiple-dose administration of FMX-101 minocycline foam, 4% in subjects with acne vulgaris.
- To assess the relative bioavailability of FMX-101 minocycline foam, 4%, compared to Solodyn® (minocycline HCl) extended-release tablets.
This Phase 1 study was a single-center, nonrandomized, open-label, active-controlled, 2-period, 2-treatment evaluation of multiple-dose topical administration of FMX-101 minocycline foam, 4%, compared to oral administration of Solodyn (minocycline HCl) extended-release tablets in subjects with moderate-to-severe facial acne vulgaris and acne additionally affecting at least 2 of the following regions: neck, upper chest, upper back, arms. 30 subjects were enrolled in 3 cohorts, and 30 subjects completed the study.
30 subjects received a single dose of Solodyn tablets, and 1 week later they received FMX-101, 4% minocycline foam, for 21 days. Solodyn was orally administered as a single dose of 1 mg/kg in accordance to its approved instructions for use. 4 grams of FMX-101, 4% was applied topically once daily for 21 days.
Top line results indicate that the relative bioavailability (systemic exposure) of FMX-101 was more than 100 times lower than that for Solodyn. FMX-101 was well tolerated, and no serious adverse events were reported in the study.
“We are pleased with the results from this study. This is another milestone in the development of FMX-101 for the treatment of moderate-to-severe acne,” stated Dov Tamarkin, PhD, Foamix CEO.
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX102 for the treatment of impetigo, FMX103 for the treatment of rosacea, and FDX104, our doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.
In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare, Merz, Allergan and Prestium.
Forward Looking Statements
This press release may include 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 of the U.S. Private Securities Litigation Reform Act of 1995. 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. FDA and other regulatory agencies authorizations. Forward-looking statements are based on our current knowledge and our 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, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital. We discuss many of these risks in greater detail under the heading “Risk Factors” in our most recent Registration Statement on Form F-1 (File No. 333-203187) declared effective on April 14, 2015, and elsewhere in that Registration Statement. Any forward-looking statements that may be made herein speak only as of the date of this release and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.