Anacor Pharmaceuticals has reported positive preliminary results from two safety studies of AN2728 ointment, 2%.
The multi-centre open label maximal use systemic exposure (MUSE) study enrolled 33 patients with extensive psoriasis to obtain a full pharmacokinetic profile in psoriatic patients under Phase 3 maximal use conditions.
The MUSE study demonstrated that patients applied with AN2728 ointment, 2% on larger body surface areas resulted in higher plasma exposure levels.
The local tolerability study was a single-centre double-blind vehicle-controlled study that randomised 32 adult healthy volunteers (3:1) to receive AN2728 ointment, 2% or ointment vehicle.
The tolerability trial is designed to evaluate the potential irritancy of AN2728 ointment, 2% when applied to sensitive skin areas and found that almost 99% of the nearly 8,700 tolerability measurements were scored as 0 with none of the treated anatomic areas appearing to be sensitive to irritation by the study drug or vehicle.
Both studies showed that AN2728 ointment, 2% was found to be safe when applied to very large body surface areas and well-tolerated when applied to areas of sensitive skin.
In multiple Phase 1 and 2 trials for mild-to-moderate psoriasis and in a recent Phase 2a study in atopic dermatitis, AN2728 has demonstrated safety and efficacy results.
Anacor Pharmaceuticals CEO David Perry said: "These data confirm the safety of AN2728 and the potential for it to be used on areas of the body that are susceptible to side effects from steroids and tend to be sensitive to irritation from vitamin D analogs.
"All of the clinical studies we have done to date on AN2728 in psoriasis and atopic dermatitis support that it could be a potentially safe and effective topical treatment for patients who suffer from mild-to-moderate psoriasis or atopic dermatitis," Perry added.
The company has filed a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) for the Phase 3 trial design of AN2728 in psoriasis.