Date: 2015-10-29
Type of information: Results
phase: 3
Announcement: results
Company: Anacor Pharmaceuticals (US - CA)
Product: crisaborole topical ointment (AN2728)
Action
mechanism: phosphodiesterase 4 inhibitor. Crisaborole topical ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor. This novel boron-containing small molecule inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.
Disease: mild-to-moderate atopic dermatitis
Therapeutic area: Dermatological diseases - Inflammatory diseases
Country:
Trial
details: The Long-Term Safety Study has enrolled patients from both pivotal Phase 3 studies. The study was designed to evaluate the long-term safety of crisaborole in subjects as young as 2 years of age. Crisaborole was administered to patients by investigators in 4-week treatment periods, as indicated pursuant to the study protocol, for up to 12 months. The study sought to enroll enough subjects so as to allow at least 300 subjects to complete six months of treatment and at least 100 patients to complete 12 months of treatment. The study enrolled a total of 517 subjects, of which 396 completed six months of intermittent treatment, and 271 completed 12 months of intermittent treatment.
Latest
news: * On October 29, 2015, Anacor Pharmaceuticals announced top-line results from the long-term safety study of crisaborole topical ointment, 2% (formerly AN2728), a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
Crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the positive Phase 3 pivotal studies reported in July 2015 . No treatment-related serious adverse events were reported and most adverse events were graded as mild in severity, and transient. The most common treatment-related adverse events reported by at least 2% of subjects were atopic dermatitis (3.1%) and application site pain (2.3%). Anacor currently expects to present additional details from this study at a future medical meeting.
