FMX102 for Impetigo
Impetigo is a highly contagious bacterial skin infection that primarily affects young children. It is typically caused by staphylococcus aureus, including MRSA, and results in red sores and lesions on the face, neck, arms and legs. MRSA infections occur in hospitals and healthcare facilities, most commonly in pediatric wards. In the early 1970s, MRSA accounted for only 2% of all staphylococcus aureus hospital-acquired infections. In 2007, it accounted for as much as 70% of these infections, warranting the need for a better treatment.
Topical antibiotic therapy is considered the treatment of choice for individuals with localized impetigo, while systemic antibiotics are used for more widespread disease. Topical mupirocin (Bactroban®) is the most commonly used product to treat impetigo, with dosing (3) three times daily for 8 to 12 days.
Foamix is developing FMX102, a 1% minocycline foam product candidate for the treatment of impetigo, including cases of impetigo caused by MRSA. We conducted a seven-day randomized, double-blind Phase II clinical trial of 32 pediatric patients ages two to fifteen with at least two impetigo lesions. Eleven patients had confirmed MRSA infection. Patients receiving FMX102 twice daily experienced an 81.3% success rate in only three days and a 100% success rate in 14 days. Moreover, all MRSA-infected patients were free of the bacteria after seven days of treatment. FMX102 was well tolerated, with none of the trial participants experiencing any drug-related side effects. Additionally, by treating the infection in as little as three days, FMX102 may effectively limit the transfer of infection from one child to the other.
The company plans to initiate Phase III clinical trials with FMX102 pending FDA discussions.
Our lead products FMX101, FMX102 and FDX104 are covered by an issued U.S. patent, which is expected to remain in effect until 2030.