US-based biopharmaceutical company Dermira has reported positive results from its Phase llb dose-ranging study of DRM01 in patients with facial acne vulgaris.
DRM01 is a new, small molecule designed to inhibit sebum production following topical application in development to treat acne.
The study evaluated the safety and efficacy of DRM01 and demonstrated statistically significant improvements in all primary endpoints compared to vehicle group at the highest dose and in most primary endpoints at the two lower doses.
It was found that DRM01 was well-tolerated with adverse events primarily mild or moderate in severity.
The trial was a randomised, multi-centre, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle in adult patients 18 and older with moderate-to-severe facial acne vulgaris.
A total of 420 patients were enrolled in the study at 34 sites in the US and Canada.
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Inclusion criteria required a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an IGA score of three or greater on a five-point scale that ranges from a score of zero, representing clear skin, to a score of four, representing severe disease.
In the study, patients were randomised into five separate arms and instructed to apply DRM01 at concentrations of 4% once daily, 7.5% once daily or 7.5% twice daily, or to apply vehicle once or twice daily, in all cases for 12 weeks.
Consistent with the previous Phase lla trial and in accordance with the published FDA draft guidance for the development of acne drugs, the primary endpoints were absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point IGA score.
Each endpoint was measured at the end of the 12-week treatment period.
Adverse events found during the study were primarily mild or moderate in severity.
The most frequently reported adverse events across all three DRM01 treatment groups were the common cold, upper respiratory tract infection and application site itching.
No treatment-related serious adverse events were reported during the DRM01Phase llb trial.