Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) was leading the bulls early in Thursday’s session on positive results from a Phase 2 study. The company announced positive top-line results from its Phase 2 clinical study of FDX104 (a topical foam containing 4% doxycycline). This drug candidate is used in the prevention of moderate-to-severe skin rashes in patients treated with the epidermal growth factor receptor antibody inhibitors (EGFRI) cetuximab (Erbitux, Eli Lilly) or panitumumab (Vectibix, Amgen) for head, neck and colon cancers, among others. The results showed a statistically significant effect of FDX104 in reducing the severity of the antibody-induced rash.
The rash, also referred to as acneiform (acne-like) rash, is the most common side effect of EGFRI drugs, and can severely impact patients’ physical, psychological and social well-being, often leading to treatment discontinuation or dose reduction.
According to the study, FDX104 appears safe and well-tolerated. No drug-related systemic adverse events were recorded. Local reactions were noted in six patients, all were mild and five were resolved before the end of the study.
Einat Shacham-Shmueli, M.D., head of the Gastrointestinal Oncology Unit, Sheba Medical Center, Israel, who was a principal investigator in this study, said:
Acneiform rash is the most noticeable side effect of EGFRI drugs. In many cases it is necessary to interrupt treatment to manage these side effects. The ability of FDX104 to reduce the incidence and severity of such rash is impressive and promising. We currently don’t have an effective treatment for this side effect, which is especially disturbing and disruptive to this population.
Dov Tamarkin, Ph.D., CEO of Foamix, said:
There is a significant unmet need for a safe and effective treatment for EGFRI-induced rash, and we are pleased with the results of this clinical study. FDX104 has the potential to improve patients’ quality of life and help maintain patients on their optimal anti-cancer treatment. We are dedicated to developing best-in-class medicines that can have a positive impact on patients’ lives.
Shares of Foamix traded up more than 18% at $9.50 Thursday morning, before dropping to $8.71 by noon. The consensus analyst price target is $19.00, and the 52-week trading range is $5.32 to $14.00.
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