Allergen/Paratek Acne Treatment Drug Passes Both Phase III Studies, Foamic Scores A Split

Written by John Carroll & Arsalan Arif

Allergan PLC (NYSE: AGN), in partnership with Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), is teeing up a new drug application for recycling after investigators reported that the acne treatment (the drug is also being studied for rosacea) scored promising data in two Phase III studies...Rivals at Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX ), however, reported today that its acne drug came up with a split decision in two Phase III studies.

 As a result of the above-mentioned news, Paratek shares had risen 11% as of mid-day, shares of Foamix had dropped by 45% and Allergen shares remained relatively unchanged (up approximately 1%).

Allergan’s partnership with Paratek is part of an ambitious effort to buy or partner up on a long range of experimental therapies for each of its core focus areas. The Botox maker has made a big investment in aesthetics and dermatology to build that franchise.

The Phase III studies compared the drug to a placebo in confirmatory trials and, while Allergan was sticking with top-line data only, the company touted a hit on the primary endpoints.

Investigators reported:

Sarecycline was statistically significantly (p < 0.004) superior to placebo with respect to primary efficacy endpoints. The most common adverse events (>2%) reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4%.

Said Dov Tamarkin, PhD, CEO of Foamix, on the split decision in their two Phase III studies:

“Whereas Trial 05 showed significance in both primary endpoints, Trial 04 did not meet significance for the IGA score endpoint.

Our team has not yet received the full data set and we intend to provide an update on the program as soon as we complete our analysis. 

As we have previously announced, the safety extensions for trials 04 and 05 are fully enrolled and continue as planned.”

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