Foamix is developing FMX101, a 4% minocycline foam product candidate for the treatment of moderate-to-severe acne.
Acne affects almost 90% of people in western societies during their teenage years and may persist into adulthood. Globally, acne affects approximately 650 million people, or about 9.4% of the population. In the U.S. alone, acne affects 40-50 million people each year, approximately 10 million of whom suffer from moderate-to-severe acne. More severe acne can cause trauma to those suffering from it. In addition to carrying a substantial risk of permanent facial scarring, acne can cause psychological strain, social withdrawal and lowered self-esteem. Early treatment is often suggested to help reduce the long-term implications associated with acne.
Oral antibiotics, such as minocycline and doxycycline, are the most commonly used treatments for moderate-to-severe cases of acne.
Minocycline and doxycycline are broad-spectrum antibiotics used for treating acne. As oral therapies, these drugs have been associated with a variety of adverse side effects, such as headaches, dizziness, fatigue, nausea, photo-sensitivity, and severe itchiness.
In 2009, the FDA added oral minocycline to its Adverse Event Reporting System, a list of medications under investigation by the FDA for their severe side effects.
FMX101 may provide a new alternative for the treatment of moderate-to-severe acne
In a survey of dermatologists, most stated that they would prescribe topical minocycline over an existing oral medication, assuming the topical treatment was safe, effective and approved by the FDA.
Utilizing our proprietary technology, Foamix is currently developing our lead product, FMX101, a novel topical foam formulation of minocycline. This technology enables us to formulate and stabilize a wide variety of drugs and deliver them directly to their target site.
FMX101 delivers minocycline directly to the acne-infected sebaceous glands in the skin. Since FMX101 is not administered orally, it does not need to travel through the bloodstream, thereby minimizing the risk of systemic side effects. Our foam platforms have significant advantages over alternative delivery options (such as ointments, creams, lotions, and gels). Foam spreads easily, it is readily absorbed, it does not leave a messy residue and is highly tolerable due to its use of gentle, safe ingredients.
Significant Efficacy Achieved in a Phase II Clinical Trial
Foamix completed a Phase II clinical trial of FMX101 involving 150 patients aged 12 to 25, with moderate-to-severe acne. Patients received a single daily dose for 12 weeks. Results from the clinical trial demonstrated both clinically and statistically significant efficacy for patients taking FMX101 versus the control group. Specifically, patients taking FMX101 had a 71% reduction in inflammatory acne lesions in only 6 weeks. In addition, patients who were given FMX101 had a 73% reduction in non-inflammatory lesions by week 12 of the clinical trial. No drug-related systemic side effects were observed.
In questionnaires completed by patients at the end of the trial:
· 86% of patients receiving FMX101 rated it as “very-highly” or “highly” effective compared to drugs they had formerly used.
· 98% of patients were generally satisfied with the ease of use of the foam.
· 92% of patients indicated they preferred the foam-based treatment over alternative topical products they had used in the past.
FMX101 is now in Phase III clinical trials for moderate-to-severe acne.
Our lead products FMX101, FMX102 and FDX104 are covered by an issued U.S. patent, which is expected to remain in effect until 2030.