Company validates clinical development pathway via FDA Type B Meeting
REHOVOT, Israel, and BRIDGEWATER, NJ, USA I August 3, 2017 I Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that the first patient has been dosed in its third Phase 3 study (Study FX2017-22) to evaluate the efficacy and safety of its topical Minocycline Foam 4%, FMX101 in patients with moderate-to-severe acne.
“During a recent Type B Meeting, the FDA confirmed that statistically significant findings from a third study would constitute replication of the Study FX2014-05 results, and would be sufficient to establish an efficacy claim. This confirmation supports our plans for conducting a third Phase 3 study,” said David Domzalski, CEO of Foamix. “Initiating this study within four months of the release of the Study 04 and Study 05 results is a direct reflection of the focus and commitment of the entire Foamix team to bring new and innovative solutions to patients.”
Study Design (FX2017-22)
FX2017-22 is a double-blind, vehicle-controlled, multi-center study that will enroll 1,500 patients with moderate-to-severe acne. This study will be conducted at approximately 80 sites throughout the United States. Patients will be randomized 1:1 to either 4% minocycline foam (FMX101) or vehicle, with once daily treatment for 12 weeks.
The primary endpoints are: 1) the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment (success is defined as a score of “clear” or “almost clear” and at least a 2 category improvement from baseline), and 2) the mean change from baseline in inflammatory lesion counts in each treatment group at week 12. Safety evaluation will include reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs.
As a result of the FDA discussion on the design of a third study, Foamix has decided to maintain the design agreed upon with FDA for Study FX2014-05.
Foamix will continue to run, in parallel, the long-term open-label safety extension to evaluate the safety of intermittent use of FMX101 under Study 04 and Study 05. The open-label safety extension is scheduled to complete by year-end 2017.
Foamix expects to report top-line results from Study FX2017-22 by mid-2018.
About Foamix Pharmaceuticals
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, FMX103 for the treatment of moderate-to-severe rosacea, FMX102 for the treatment of impetigo, 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 and others.
For more information, please visit www.foamixpharma.com.
SOURCE: Foamix Pharmaceuticals
Post Views: 29
Company validates clinical development pathway via FDA Type B Meeting
REHOVOT, Israel, and BRIDGEWATER, NJ, USA I August 3, 2017 I Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that the first patient has been dosed in its third Phase 3 study (Study FX2017-22) to evaluate the efficacy and safety of its topical Minocycline Foam 4%, FMX101 in patients with moderate-to-severe acne.
“During a recent Type B Meeting, the FDA confirmed that statistically significant findings from a third study would constitute replication of the Study FX2014-05 results, and would be sufficient to establish an efficacy claim. This confirmation supports our plans for conducting a third Phase 3 study,” said David Domzalski, CEO of Foamix. “Initiating this study within four months of the release of the Study 04 and Study 05 results is a direct reflection of the focus and commitment of the entire Foamix team to bring new and innovative solutions to patients.”
Study Design (FX2017-22)
FX2017-22 is a double-blind, vehicle-controlled, multi-center study that will enroll 1,500 patients with moderate-to-severe acne. This study will be conducted at approximately 80 sites throughout the United States. Patients will be randomized 1:1 to either 4% minocycline foam (FMX101) or vehicle, with once daily treatment for 12 weeks.
The primary endpoints are: 1) the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment (success is defined as a score of “clear” or “almost clear” and at least a 2 category improvement from baseline), and 2) the mean change from baseline in inflammatory lesion counts in each treatment group at week 12. Safety evaluation will include reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs.
As a result of the FDA discussion on the design of a third study, Foamix has decided to maintain the design agreed upon with FDA for Study FX2014-05.
Foamix will continue to run, in parallel, the long-term open-label safety extension to evaluate the safety of intermittent use of FMX101 under Study 04 and Study 05. The open-label safety extension is scheduled to complete by year-end 2017.
Foamix expects to report top-line results from Study FX2017-22 by mid-2018.
About Foamix Pharmaceuticals
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, FMX103 for the treatment of moderate-to-severe rosacea, FMX102 for the treatment of impetigo, 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 and others.
For more information, please visit www.foamixpharma.com.
SOURCE: Foamix Pharmaceuticals
Post Views: 29
