Foamix’s rosacea antibiotic on track for 2019 NDA with positive phase 3 data

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Foamix is using its foam platform to develop topical antibiotics for skin conditions that do not cause systemic side effects that come with oral antibiotics. (Nadine Doerlé)

Foamix Pharmaceuticals’ topical antibiotic for rosacea met its coprimary endpoints in two phase 3 trials. The drug achieved “treatment success” in about half of the 1,522 patients enrolled in the trials and decreased the number of inflammatory lesions from baseline.

The company, which has offices in Rehovot, Israel, and Bridgewater, New Jersey, expects to report further data, including from a long-term safety extension study, into the first half of next year.

“Assuming all goes well, we anticipate we will be in a position to file an NDA toward the end of next year,” said Foamix CEO David Domzalski.

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The drug, FMX103, is a foam formulation of 1.5% minocycline, an oral antibiotic used to treat a variety of bacterial infections, such as urinary tract infections and respiratory infections, as well as skin infections. It can be used to treat moderate to severe rosacea, but like other oral antibiotics, it can lead to nasty side effects, including dizziness, nausea, severe stomach pain and skin rash or skin lesions.

“The phase 3 results signal efficacy and an excellent safety profile,” Domzalski said. “Specifically, we’re not seeing the systemic side effects you see with systemic therapies. There are very low dermal side effects.”

The trials, FX2016-11 and FX2016-12, were identical, double-blind, randomized, vehicle-controlled studies that enrolled 751 and 771 patients, respectively. The patients, all adults, had moderate to severe papulopustular rosacea. Over 12 weeks, two-thirds of the patients received a daily dose of FMX103 and one-third received vehicle foam.

The studies used Investigator Global Assessment (IGA) scores to measure treatment success. IGA scores range from clear (0) to severe (4), with mild and moderate in between. Treatment success was defined as an IGA score of 0 or 1—clear or mild—with at least a two-grade decrease from their baseline of 3 or 4. In one trial, FX2016-11, 52.1% of the treated patients achieved this improvement, while the number was 49.1% in the second trial.

“These results are impressive, with treatment success being achieved in a high proportion (approximately 50%) of patients as well as clinically meaningful reductions in inflammatory lesions,” said Linda Stein Gold, M.D., a dermatologist at Henry Ford Health System, principal investigator in Study FX2016-12 and adviser to Foamix, in the statement.

“Papulopustular rosacea is a serious medical condition that can cause considerable psychological distress to affected patients. Despite the prevalence of disease, there has been limited innovation from industry. If approved, based on the compelling data from these clinical trials, I believe FMX103 could become a valuable treatment approach for rosacea."

And Foamix won't stop there. The rosacea data come on the heels of positive results from a trial of a different version of minocycline foam in moderate to severe acne. The foam platform has "a lot of utility for the development of other products for other skin conditions," Domzalski said. While he kept potential disease and conditions under wraps, the company plans to "provide more insight" on future products as the year goes on.