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Foamix claims goal-winning success in twin pivotal studies for rosacea — shares spike

The roller coaster ride that Foamix Pharmaceuticals has taken investors on is on an upswing track this morning. The biotech reported that its topical formulation of the antibiotic minocycline scored on the co-primary endpoints in treating inflammatory lesions caused by rosacea came through with positive results.

The Israeli company’s shares $FOMX gyrated upward Wednesday morning, jumping about 25% in pre-market trading. It’s still under the $6 price the biotech hit when it launched an IPO on Nasdaq in 2014.

Linda Stein Gold

The biotech says that their parallel studies — FX2016-11 and FX2016-12 — performed well, though we won’t have the hard data until later. Success was measured as a significant response on an “absolute change from baseline in inflammatory lesion count at Week 12, and Investigator Global Assessment treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.”

Back in the spring of 2017, Foamix offered a mixed set of data from two Phase III studies for their acne program. That inspired the start of a third late-stage study in search of positive results from two trials to take to the FDA, which they recently announced was positive. 

Foamix left it to the chief investigator to offer an upbeat assessment of the rosacea data, which will be detailed at a later date.

“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,” says Linda Stein Gold, the principal investigator, in a prepared statement. “Papulopustular rosacea is a serious medical condition that can cause considerable psychological distress to affected patients.” 


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