PBR Staff Writer Published 27 March 2017
A phase 2 trial of Xenon Pharmaceuticals’ acne drug XEN801 has failed to meet its efficacy endpoints in patients having moderate to severe acne.
The trial results could not show the topical stearoyl Co-A desaturase-1, or SCD1 inhibitor, XEN801 producing any statistically considerable difference in the primary endpoint of the percent change in total lesion count from baseline to week 12 when compared to the vehicle placebo. The count included both inflammatory and non-inflammatory lesions.
Also, the phase 2 trial did not record any statistical significance made by XEN801 in terms of important secondary efficacy endpoints.
Among the secondary endpoints is the change in percentage of inflammatory and/or non-inflammatory lesions at various time points during the 12-week trial along with several Investigator’s Global Assessment (IGA) measures.
However, the company’s candidate did note a positive safety and tolerability profile, causing no serious adverse events in the patients.
Xenon president and CEO Simon Pimstone said: “Despite the good scientific and preclinical rationale to pursue SCD1 as a novel acne target, the topline clinical results do not support this hypothesis or the continued development of XEN801.
“While we are disappointed that XEN801 did not demonstrate efficacy in the treatment of acne, we have a broad, diversified pipeline of small molecule ion channel modulators based on targets with high human validation that we continue to advance.”
The phase 2 trial, which was initiated by Xenon in February 2016, featured nearly 150 patients in a randomized, multi-center, double-blind, vehicle-controlled, parallel-group.
It had acne patients apply either XEN801 or vehicle placebo topically to their face, depending on the groups they were randomized into, for a period of 12 weeks with a follow up after four weeks.