Home / Acne / Foamix’s acne drug misses main goal in key study, shares slump

Foamix’s acne drug misses main goal in key study, shares slump

Foamix Pharmaceuticals Ltd said on Monday its experimental acne treatment failed to meet one of two main goals in a late-stage study, pushing its shares down about 42 percent.

However, the drug, FMX101, succeeded in a separate late-stage study, the Israel-based drug developer said.

FMX101, is a topical version of a decades-old acne treatment called minocycline, which already exists in an oral form, but can lead to serious side effects.

The two trials included a total of 961 patients with moderate-to-severe acne, and tested FMX101 against a placebo. Each trial had two main goals – the reduction in lesions and an assessment made by investigators using an acne severity scale.

While the drug induced a statistically significant reduction in lesion count in both trials, it met the main goal in relation to the acne scale in just one study.

“Foamix did hit three of their four endpoints in the phase 3 studies, so we think the drug works”, Guggenheim Securities’ Louise Chen said.

Foamix is analyzing the data and plans to discuss its next steps with the U.S. Food and Drug Administration (FDA), the company said.

It seems that a path forward depends on whether the FDA would consider the remainder of data sufficient for filing and approval, Barclays analysts said.

They questioned whether there may be a read-through to Foamix’s experimental rosacea drug, FMX103, which is expected to go into a late-stage study in 2017.

Companies developing acne treatments include Dermira Inc, Allergan Plc, Novan Inc and Xenon Pharmaceuticals Inc.

Last week, Xenon said it would discontinue developing its acne drug after it failed a mid-stage study.

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About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

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