AN2898 / Pfizer - LARVOL DELTA

"COPY" - Anacor Pharmaceuticals announces positive preliminary results from two safety studies of AN2728 and updates atopic dermatitis results and regulatory status (Anacor) - P3: N=33; MUSE; Anacor announced positive preliminary results from two safety studies of AN2728; In maximal use systemic exposure (MUSE) study in psoriatic pts application of AN2728 Ointment, 2% on larger body surface areas resulted in higher plasma exposure levels but did not correlate with greater adverse events; In local tolerability study (N=32) 99% of the nearly 8,700 tolerability measurements were scored as 0 (none); None of the treated anatomic areas appeared to be particularly sensitive to irritation by the study drug or vehicle; No serious adverse events were observed in the trial; P2a, N=46; Final audited data demonstrate a slight improvement in the AN2728 treatment group, while the results for AN2898 did not change; 68% of AN2728-treated lesions showed greater improvement in Atopic Dermatitis Severity Index (ADSI) score versus 20% for vehicle (p=0.02) & 71% of AN2898-treated lesions showed greater improvement in ADSI score vs. 14% for vehicle (p=0.01); Anacor requested a Spe

FDA SPA discussion • P2 data • Regulatory update • Safety data • Immunology • Psoriasis

Anacor Pharmaceuticals announces positive preliminary results from two safety studies of AN2728 and updates atopic dermatitis results and regulatory status (Anacor) - P=NA, N=33; MUSE; In maximal use systemic exposure (MUSE) study in psoriatic pts application of AN2728 ointment, 2% on larger body surface areas resulted in higher plasma exposure levels but did not correlate with greater AE; In local tolerability study (N=32) 99% of the nearly 8,700 tolerability measurements were scored as 0 (none); None of treated anatomic areas appeared to be particularly sensitive to irritation by study drug or vehicle with no serious AE; P2a, N=46; Final data demonstrate a slight improvement in AN2728 group, while results for AN2898 did not change; 68% of AN2728-treated lesions showed greater improvement in Atopic Dermatitis Severity Index (ADSI) score vs. 20% for vehicle (p=0.02) & 71% of AN2898-treated lesions showed greater improvement in ADSI score vs. 14% for vehicle (p=0.01); Anacor requested a SPA from FDA for P3 trial in psoriasis; Anacor anticipates AN2728 development activities on atopic dermatitis in 2012 & will defer start of P3 trial in psoriasis

FDA SPA discussion • P2 data • Regulatory update • Safety data • Immunology • Psoriasis

Safety and efficacy of AN2728 and AN2898 ointments in a phase 2a bilateral study of mild-to-moderate atopic dermatitis (SID 2012) - P2, N=46; AN2898-AD-202; Compared with those treated with vehicle, lesions treated with AN2728 ointment, 2% as well as those treated with AN2898 ointment, 1% achieved greater improvement in Atopic Dermatitis Severity Index (ADSI) in a higher proportion of pts after 4 weeks; AN2728 ointment, 2% & AN2898 ointment, 1% each outperformed vehicle ointment in mean improvement of lesion severity from baseline as well as in the proportion of lesions achieving total or partial clearance (ADSI ≤2) at same time point; No serious AEs were observed

P2 data • Immunology • Psoriasis

Application of Topical Phosphodiesterase 4 Inhibitors in Mild to Moderate Atopic Dermatitis: A Systematic Review and Meta-analysis. (PubMed, JAMA Dermatol) - "This meta-analysis suggests that topical PDE4 inhibitors are a safe and effective treatment for mild to moderate AD. Current evidence supports the use of crisaborole or AN2898 as the choice of maintenance or sequential therapy for mild to moderate AD."

Journal • Retrospective data • Review