PMX53

Complement is a key component of the inflammatory cascade and is implicated in a number of human inflammatory diseases.  Arana is developing several formulations of PMX53 – an inhibitor of the human C5a ‘complement’ factor receptor – as a potential new anti-inflammatory treatment for diseases such as Age-Related Macular Degeneration (AMD) and arthritis. PMX53 is a cyclic hexapeptide compound and behaves as an insurmountable antagonist with nanomolar affinity for the human C5a receptor.

Potential indications for complement inhibitors may include:

Source: Nature Biotechnology

Development Status

Arana acquired PMX53 from Promics Pty Ltd who had successfully completed the following clinical trials:

Indication	Route	Dose	n	Duration	Design
Volunteers	Oral	0, 0.3, 1, 3 or 10 mg/kg	24	Single dose	Double blind, placebo controlled, single ascending dose (safety & PK)
Rheumatoid Arthritis	Oral	8 mg/kg	21	28 days	Randomised, parallel, double blind placebo controlled study to assess safety, PK  and tolerability
Psoriasis	Topical	5 mg/ml – BD application	10	56 days	Open label, non-controlled

Arana has undertaken significant formulation studies and preclinical development of PMX53 for clinical conditions which included age related macular degeneration (AMD) and osteoarthritis. On the 19th February 2009, Arana announced that it has discontinued clinical development of PMX53 for ocular indications. While PMX53 has shown activity in AMD models, the level of activity was deemed insufficient to warrant further development expenditure. As a consequence Arana is not proceeding with the clinical trial of PMX53 in AMD previously scheduled for Q2 2009.

All ongoing pre-clinical PMX53 studies will be taken to completion including an osteoarthritis study which is expected to be completed by Q3 2009, and a data package is being assembled in preparation for out-licensing.