Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results

November 2020 | Volume 19 | Issue 11 | Original Article | 1093 | Copyright © November 2020


Published online November 4, 2020

Steven Kempers MD,a Janet DuBois MD,b Seth Forman MD,c Amy Poon BS MA,d Eva Cutler BS BA,d
Hui Wang PhD,d David L. Cutler MD FRCP(C),d Jane Fang MD,d Rudolf Kwan MBBS MRCPd

aMinnesota Clinical Study Center, New Brighton, MN
bDermResearch, Austin, TX
cForCare Medical Center, Tampa, FL
dAthenex, Inc., Buffalo, NY





counts occurred by day 15 in the 5-day (-2.5 [2.48]) and 3-day cohorts (-2.5 [2.22]) that continued up to day 57 (-3.9 [2.00] and -3.4 [1.75], respectively) (Figure 2) . Even with small participant numbers, consistency in AK clearance among subgroups was noted.

All 63 participants who had 100% clearance at day 57 in the Phase 2 study were included in the Recurrence Follow-up Set. Based on Kaplan-Meier analysis, at 12 months post-day 57, recurrence rates for the proportion of 5 day cohort participants were lower than the 3-day cohort (57% [95% CI, 41, 73] vs 70% [95% CI, 51, 87]). Most recurrence occurred within 6 months post-day 57.

Safety
In the Phase 1 study, no TEAEs were treatment-related, severe, or resulted in withdrawal from the study or treatment. There were no deaths or SAEs. No clinically significant changes in laboratory tests, vital signs, physical examinations, or electrocardiograms were reported. Application-site symptoms, collected separately from AEs, were mostly transient mild pruritus, and less frequently stinging/burning sensation. These were observed predominantly in Cohorts 3/4; all resolved without treatment.

In the Phase 2 study, all participants completed treatment and follow-up to day 57, and both regimens were well tolerated. There were no deaths, SAEs, or discontinuations due to treatment. Twelve of 168 participants (7%) had treatmentrelated AEs: 9 (11%) in the 5-day cohort and 3 (4%) in the 3-day cohort. Treatment-related AEs were mostly mild, transient application-site pruritus and application-site pain that resolved spontaneously. Three participants reported four treatmentrelated non-specific systemic AEs: transient mild-to-moderate dizziness and mild headache. One participant reported mild hair darkening near the treatment area, and another was