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), psoriasis and arthritis.  PMX53 is a cyclic hexapeptide compound with nanomolar affinity for the human C5a receptor and behaves as an insurmountable antagonist of C5a.

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 is now in the process of optimising new formulations as well as undertaking pre-clinical validation in several inflammatory models.  A new formulation will be taken to Phase I and subsequent Phase II clinical trials will be progressed for selected indications. Success in these trials would provide early prospects for commercialisation.
Arana’s lead indication for PMX53 is the wet form of Age-Related Macular Degeneration (AMD), an eye disease affecting millions worldwide.
AMD is associated with aging and the patient gradually loses sharp, central vision, needed for seeing objects clearly and for common daily tasks such as reading and driving.
Treating patients with AMD can be substantially more expensive than treating patients with other eye diseases and the potential market for is approximately US$5 billion annually.
Advanced AMD can cause a rapid loss of central vision and may lead to a complete loss of vision in both eyes. It is estimated that 1.64 million US residents now have significant symptoms associated with wet AMD, with that number expected to grow to almost 17 million by 2020.

We have the opportunity to develop a major presence in the AMD market