Opsona Therapeutics Ltd. commences Part B of phase II study of Blocking Toll-Like Receptor 2 in Extended Criteria Donor renal transplant recipients at high risk of Early Graft Dysfunction

2nd March 2015, Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune inflammatory diseases and oncology, today announced the continuation of its double-blind renal transplant study by the initiation of Part B of its adaptive phase II clinical trial in Extended Criteria Donors (ECD) renal transplant recipients at high risk of early graft dysfunction with its lead drug candidate OPN-305.

Based on the completion of Part A of this double blind study, OPN-305 was well tolerated and deemed to be safe by the data and safety monitoring board across all dose groups with no evidence of increased risk of infection in these highly immuno-suppressed patients.

The company is proceeding with Part B in a modified patient population evaluating ECD-only recipients. ECD kidneys make up the largest pool of the cadaveric donor population. Currently up to 45% of ECD kidneys are discarded resulting in a significant deficit in supply versus demand. OPN-305 has the opportunity to turn borderline non-transplantable organs into viable kidneys and functioning grafts resulting in fewer ECD discards, driving an overall increase in the number of deceased donor transplants.

Commenting on today’s announcement, Mary Reilly VP Pharmaceutical Development & Operations said: “We are excited about the initiation of Part B and hope that we can demonstrate an effect of TLR2 blockade on reducing early graft dysfunction in this patient population which is a significant unmet medical need.
Opsona remains committed to further development of OPN-305 and believe that OPN-305 has the potential to be first and best-in-class while also providing a novel treatment option for a wide variety of autoimmune, inflammatory and oncology diseases.”

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For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)
• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)
• BB Biotech Ventures (www.bbbiotechventures.com)
• EMBL Ventures (www.embl-ventures.com)
• Enterprise Ireland (www.enterprise-ireland.com)
• Fountain Healthcare Partners (www.fh-partners.com)
• GenenFund (www.gene.com)
• Inventages Venture Capital (www.inventages.com)
• Novartis Venture Fund (www.nvfund.com)
• Omnes Capital (www.omnescapital.com)
• Roche Venture Fund (www.venturefund.roche.com)
• Seroba Kernel Life Sciences (www.seroba-kernel.com)
• Sunstone Capital (www.sunstone.eu)