Development of OPN-305 as an orphan drug for the t.. (MABSOT)
Development of OPN-305 as an orphan drug for the treatment of Delayed Graft Function post solid organ transplantation
Start date: Dec 1, 2010,
End date: Sep 30, 2014
Delayed graft function (DGF) is defined as the need for dialysis within seven days of renal transplantation (DGF promotes allograft rejection, requires prolonged dialysis and hospitalisation, and increases the likelihood of graft failure and ultimately the duration of renal graft survival-expectancy. The incidence of DGF occurs in 21-44% of cases following cadaveric renal graft. Several rare diseases, particularly those of genetic origin, are associated with the requirement for solid organ transplantation as the disease progresses. At Opsona Therapeutics we have developed a novel antibody (OPN-305) which has received OMP designation (EU/3/09/638) for use in the prevention of DGF. The scientific basis of this development is the inhibition of Toll-like receptor 2 (TLR2)-mediated ischaemic reperfusion injury which has a pivotal role in the pathogenesis of DGF and its sequelae. The MABSOT project is designed to progress the development of this OMP through Phase I and II clinical trial. The successful completion of the programme will allow the continued development of OPN-305 as an OMP for the treatment of DGF in a range of solid organ transplant situations. OPN-305 development will have significant benefit to these patients and health care providers in reducing the prolonged hospitalisation of these individuals, providing greater longevity associated with the transplanted organ and enhanced quality of life for these individuals.
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