Dermira's Acne Candidate Fails In Pivotal Trials, Shares Sink
Zacks Investment Research | Mar 05, 2018 10:36PM ET
Dermira, Inc.’s (NASDAQ:DERM) shares plunged more than 65% following the failure of its acne candidate, olumacostat glasaretil, in two pivotal phase III studies. The candidate failed to meet the co-primary endpoint in two studies – CLAREOS-1 and CLAREOS-2.
Shares of the company have significantly underperformed the industry in the past year. The stock has lost 76.4% versus the industry’s 2.2% gain.
The phase III clinical program comprising two pivotal studies, was evaluating olumacostat glasaretil for treating moderate-to-severe acne vulgaris in patients aged nine years and above as compared to a vehicle group over a period of 12 weeks.
The candidate reduced the numbers of inflammatory lesions from baseline by 14.3 and 16.6 in the CLAREOS-1 and CLAREOS-2 studies, respectively, compared with 13.7 and 15.3 in the corresponding vehicle groups. Decrease in the numbers of non-inflammatory lesions from baseline was 14.8 and 17.8 for olumacostat glasaretil in comparison to 11.2 and 17.4 for the vehicle group. These results were not statistically significant.
The second primary endpoint was the percentage of patients, who achieved at least a two-grade improvement from baseline to a final grade of zero or one on the Investigator’s Global Assessment scale. Under the CLAREOS-1 and CLAREOS-2 studies, the percentage of patients who achieved this target at week 12 were 19.1% and 16.3%, respectively, which was again not a statistically significant improvement in comaprison to 20.8% and 11.8% in the corresponding vehicle groups.
The clinical program also included an additional phase III study, CLARITUDE, which would have evaluated the candidate on patients from either of the two Phase III studies, who were permitted to continue receiving therapy for up to additional 36 weeks.
Notably, Dermira is a small-scale biopharmaceutical company, focused on developing treatment for chronic skin conditions. Though it continues to analyze the outcome of the phase III program in acne, it is likely to discontinue the same based on available data.
Apart from olumacostat glasaretil, the company has glycopyrronium tosylate and lebrikizumab in its pipeline. Glycopyrronium tosylate is under review in the United States for the treatment of axillary hyperhidrosis. A decision is expected later this year. A phase IIb study is evaluating lebrikizumab for moderate-to-severe atopic dermatitis.
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