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Foamix clears one phase 3 trial, misses co-primary endpoint in another

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Foamix clears one phase 3 trial, misses co-primary endpoint in another

Foamix Pharmaceuticals Ltd. reported the results of two phase 3 trials evaluating its acne treatment FMX101.

Both trials had the same co-primary endpoints: absolute change in the number of inflammatory lesions and proportion of patients with investigator's global assessment, or IGA, success.

IGA is a scale to measure the severity of acne.

One of the trials showed significance in both primary endpoints, whereas the other met the first co-primary endpoint but failed to demonstrate statistical significance in IGA success.

Both trials also showed that FMX101 was generally safe and well-tolerated.

Foamix CEO Dov Tamarkin noted that the company will provide an update on the program after completing further analysis and that the safety extensions of the trials were fully enrolled and would continue as planned.

The company also said that as of end 2016 it had cash and investments of $131 million, which was sufficient until mid-2019.