Astion Pharma to Commence International Phase III Clinical Studies With ASF-1057 in Seborrheic Dermatitis

COPENHAGEN, December 10 /PRNewswire/ -- Patient enrolment for the pivotal Phase III studies of ASF-1057 for the treatment of seborrheic dermatitis has now commenced as planned. The studies will include approximately 1200 patients. The commencement of the Phase III programme is based on successful results from a Phase II programme which demonstrated a significant, favourable effect on the clinical symptoms of seborrheic dermatitis as well as a good safety profile.

Astion Pharma has initiated an international Phase III clinical programme for ASF-1057 in seborrheic dermatitis. The Phase III programme will include 1200 patients in three separate studies. Two pivotal placebo-controlled studies are designed to document the effect of ASF-1057 in the treatment of seborrheic dermatitis and establish the safety profile in short-term treatment. Another study will focus on safety in the use of ASF-1057 in long-term treatment. The Phase III programme has been discussed with the health authorities in several European countries. Based on advice from the regulatory authorities, Astion Pharma expects that the Phase III programme will potentially form the basis for a registration of ASF-1057 in Europe for seborrheic dermatitis if the results meet expectations for efficacy on the primary endpoints. The studies are expected to be completed within 12-18 months.

- We have great expectations for ASF-1057 as it is a new product targeting seborrheic dermatitis. In earlier studies, ASF-1057 demonstrated an effect comparable to or greater than that of the approved drugs, and the fact that ASF-1057 has a very favourable safety profile makes it a promising alternative therapy to the existing drugs, said Lars Smedegaard Andersen, CEO of Astion Pharma.

Pivotal placebo-controlled and active-controlled Phase III study

This study is scheduled to enrol 700 patients in three treatment groups as follows:

- ASF-1057 - 300 patients

- Placebo - 100 patients

- Ketoconazole 2% cream - 300 patients

Patients with moderate to severe facial seborrheic dermatitis will be enrolled in the study and treated for four weeks after randomisation. The primary endpoint is treatment response after 21 days' of treatment measured on the clinical relevant scale "Overall Severity Score" (the OSS scale).

The study includes an active comparison with the anti-fungal agent ketoconazole 2%. Ketoconazole is the most widely used drug in the treatment of seborrheic dermatitis and is approved in most EU member states for this disorder. The patient recruitment is planned to include some 40 centres in Europe and Canada.

Pivotal placebo-controlled Phase III study:

This study is scheduled to enrol 500 patients in three treatment groups as follows:

- ASF-1057 - 300 patients

- Placebo - 100 patients

- Vehicle (neutral moisturising cream) - 100 patients

Patients with moderate to severe facial seborrheic dermatitis will be selected and treated for 21 days after randomisation. The primary endpoint is the same as in the study above.

Patients are expected to be enrolled at approximately 30 treatment sites in Europe and Canada.

ASF-1057 is composed of an anti-inflammatory compound - glycerol monocaprylate (GMCY) formulated in a base cream containing the excipient nicotinamide. In trials, GMCY has demonstrated specific relevance for the inflammatory process in seborrheic dermatitis. Nicotinamide has a well-known, mildly beneficial effect on skin inflammation as it improves the skin barrier function and reduces the loss of fluid through the skin.

Conclusion from the Phase II programme

Astion has conducted four explorative Phase II studies of 315 patients in seborrheic dermatitis. The objectives of the Phase II programme was (1) to document the basic efficacy of ASF-1057 in Seborrheic dermatitis, (2) to establish the optimal dosage of GMCY, (3) to determine the optimal combination of the active ingredient, GMCY, and the excipient nicotinamide, and (4) to evaluate the safety profile.po

Both individually and combined in a meta-analysis, the results from the Phase II clinical studies document the efficacy of ASF-1057 after three weeks of treatment. The effect was most pronounced for the dosage of 0.5% GMCY in a 4% nicotinamide cream, which is the selected dose for the phase 3 programme. An effect was demonstrated on the primary efficacy endpoint and on clinically relevant secondary endpoints: erythema, scaling and itching. On the primary efficacy endpoint, a statistically significant efficacy was seen after three weeks and as early as after one week's treatment compared with a conventional moisturising cream.

In Phase II clinical studies and in pharmacological studies, ASF-1057 has proved to be well-tolerated and not potentially causing dermal atrophy, phototoxic reactions or hypersensitivity.

Seborrheic dermatitis

Seborrheic dermatitis is an inflammatory dermatological disease affecting the upper skin layers. Seborrheic dermatitis is characterised by a red, greasy and scaly eczema, typically occurring on the face, chest and/or scalp. The symptoms are often associated with itching. Facial seborrheic dermatitis is estimated to affect 3-4% of the population. Typical treatment consists of anti-fungal creams and/or steroid creams. The aetiology and development of the disease is complex and has yet to be fully explained. Several factors such as an increase in the release and breakdown of lipids from sebaceous glands, effects from the malassezia yeast fungus, and neurogenic inflammation contribute to the disease.

Astion Pharma A/S develops pharmaceutical products for the treatment of skin diseases. It is estimated that one person in four worldwide will suffer from a skin diseases sometime in life, causing a deterioration of their quality of life. It is the Company's goal to become a leading player in the treatment of skin diseases for which there is currently a major need for new and better therapies. Astion Pharma has a strong platform of proprietary technologies for the development of new and innovative products. The Company pursues development activities through a strong international network of scientific partners and leading contract research organisations. The company currently has one development project in Phase III in seborrheic dermatitis and two development projects in Phase II in cutaneous lupus and itching, as well as a large portfolio of product candidates and research programmes in earlier phases. For additional information please visit our web site: http://www.astion.com.

For additional information please visit our web site: http://www.astion.com.

CONTACT: Contact person: Lars Smedegaard Andersen, Tel: +45-4333-4802,
E-mail: lsa@astion.com