EU awards €5.9m to Opsona Therapeutics for clinical development of lead drug candidate OPN-305

  • - Trans-European Consortium to start clinical development of OPN-305 this year
  • - Clinical trials to target solid organ transplantation

06 May,  2011-- DUBLIN, Ireland -- Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has been awarded  €5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) in the advancement of clinical trials for its lead drug candidate OPN-305 in solid organ transplantation.  A phase 1 trial in healthy volunteers is due to start this summer.

Commenting on today's announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said, "We are very excited to have the opportunity to coordinate this important trans-European consortium.  Improvement of graft function, specifically in renal transplantation, continues to be an area of unmet medical need, requiring truly innovative therapeutic approaches such as OPN-305."

The specific focus of the Consortium will be the development of OPN-305 as a therapeutic agent for the prevention of Delayed Graft Function (DGF), a serious complication of the immediate postoperative period in renal transplantation.  OPN-305 is a monoclonal antibody inhibitor of Toll-like-receptor-2 (TLR-2).

Data generated by Opsona, its collaborators and independent scientists has provided solid scientific evidence for a link between TLR-2 and DGF. The consequences of DGF can be prolonged hospitalisation of patients, additional invasive procedures and transplant rejection.  

There is currently no specific therapeutic treatment for DGF.  Following successful completion of the Phase 1 trial this year, the consortium plans to conduct a prospective randomized placebo-controlled Phase 2 trial in the prevention of DGF to be initiated in 2012.

Dr. Seizinger went on to comment on the broader potential of OPN-305, "Since OPN-305 targets TLR-2, a key component of innate immunity, this first-in-class antibody against TLR-2 may have even greater medical and commercial potential for the novel treatment of a broad range of human diseases including cancer and cardiovascular disease."

The Monoclonal Antibody Solid Organ Transplantation (MABSOT)* consortium which has been partially funded by the European Commission Seventh Framework Program (FP7) consists of  Kings College London (UK),  Katholieke Universiteit Leuven (Belgium),  Fundacio Privada Institut D'Investigacio Biomedica De Bellvitge (Spain), Academisch Ziekenhuis Groningen (Netherlands), Institut Klinické a Experimentální Medicin  (Czech Republic), University of Newcastle Upon Tyne (UK), Euram Ltd (UK) and Almac Diagnostics Ltd (UK), together with Opsona Therapeutics Ltd. (Ireland).

"We are proud, particularly as a Small/Medium Enterprise, to lead and coordinate this important collaborative effort which brings together many outstanding scientists, transplant surgeons and medical opinion leaders in the field of immunology and transplantation from across Europe" said Mary Reilly, VP Pharmaceutical Development and Operations, and MABSOT coordinator with the European Commission.

Further information on the objectives of the MABSOT consortium can be found on the projects website, http://www.mabsot.eu/.

About Opsona Therapeutics

Opsona is a 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, transplant rejection, cancer, diabetes, Alzheimer's disease and atherosclerosis.

The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin.  Opsona has two lead programs that modulate the innate immune system, including biologics and small molecules. 

Opsona's lead product, a fully humanized monoclonal antibody (OPN-305) against Toll-like-receptor-2 (TLR-2) has demonstrated  activity  in a number of animal models and will start clinical trials in 2011 Opsona has also signed significant partnering and collaborative deals, with Pharmaceutical companies  such as  Pfizer (USA).

Headquartered in Dublin, Opsona most recently completed a €21.3m financing round with an international investor consortium including: Inventages Venture Capital, Novartis Venture Fund,  Roche Venture Fund, Seroba-Kernel Life Sciences, Fountain Healthcare Partners  and Enterprise Ireland.  http://www.opsona.com/