TopoTarget reports promising Phase II trial results with Avugane™ in acne vulgaris

TopoTarget A/S (CSE: TOPO) reports promising results following a Phase II trial of its new HDAC-inhibitor, Avugane™ in the topical treatment of acne vulgaris.

In a double-blind, randomised Phase II study including 34 patients, Avugane™ showed comparable efficacy and advantageous tolerability compared with a standard, marketed retinoid therapy. Avugane™ also showed indications of an acceleration of the clinical response. The results support the further development of Avugane™ for the topical treatment of inflammatory skin diseases. TopoTarget intends to out-licence the drug to a partner with expertise in the dermatological field.

This Phase II three arm study compared the efficacy and safety of topically applied Avugane™ monotherapy in the treatment of mild to moderate acne vulgaris with isotretinoin, an established, marketed retinoid drug, and a combination Avugane™/isotretinoin therapy. Patients in the study were treated over 12 weeks, and the clinical end points for this trial included the evaluation of therapeutic efficacy based on counts of facial acne lesions as well as safety and tolerability measurements. The trial was conducted at one centre in Frankfurt, Germany and two centres in Moscow, Russia.

Topical treatment with Avugane™ monotherapy and isotretinoin monotherapy resulted in a similar reduction in total counts of facial acne lesions but with indications of an accelerated clinical response in the AvuganeTM monotherapy arm. Avugane™ therapy resulted in a reduction of both inflammatory and non-inflammatory types of acne lesions. The combination of Avugane™ and isotretinoin did not result in a detectable additive reduction of lesion counts.

Avugane™ was predominantly judged by the patients in the trial to be “well” tolerated, indicating a better local tolerability of Avugane™ compared with isotretinoin and with the combination therapy. The adverse events observed during the treatment with Avugane™ primarily consisted of reddening, dryness or irritation/reaction of the skin at the site of application.

Prof. Dr. Hans Christian Wulff, dermatologist at Bispebjerg hospital, Copenhagen, commented: “Avugane™ represents a promising novel mechanism-of-action for the treatment of acne vulgaris. The results from this Phase II study show that the drug may represent a new and interesting therapeutic option for patients who do not respond effectively to current standard medications.”

Peter Buhl Jensen, M.D. and CEO of TopoTarget commented: “Acne vulgaris represents a significant unmet medical need and we are very encouraged by these results. We aim to continue development of this promising drug, while seeking an out-licencing partner with expertise in the dermatological field. In parallel with our work on Avugane™, TopoTarget is investigating the therapeutic potential of Baceca®, which is based on the same HDAC inhibitor as Avugane™. We very much look forward to the results from our two Baceca® Phase II trials in Basal Cell Carcinoma, which we expect in the end of 2006.”

The results do not change TopoTarget’s expectations for 2006.