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7E12023

Development of OPN-305 as an orphan drug for the treatment of Delayed Graft Function post solid organ transplantation

Public support

  • Provider

    Ministry of Education, Youth and Sports

  • Programme

  • Call for proposals

    FP7-HEALTH-2010-single-stage

  • Main participants

  • Contest type

    RP - Co-financing of EC programme

  • Contract ID

    34668/2012-32

Alternative language

  • Project name in Czech

    Development of OPN-305 as an orphan drug for the treatment of Delayed Graft Function post solid organ transplantation

  • Annotation in Czech

    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 (OPN305) 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 IIa clinical trial. The successful completion of the programme will allow the continued development of OPN305 as an OMP for the treatment of DGF in a range of solid organ transplant situations. OPN305 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.

Scientific branches

  • R&D category

    AP - Applied research

  • CEP classification - main branch

    FJ - Surgery including transplantology

  • CEP - secondary branch

    FJ - Surgery including transplantology

  • CEP - another secondary branch

    FJ - Surgery including transplantology

  • OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)

    30212 - Surgery<br>30213 - Transplantation

Completed project evaluation

  • Provider evaluation

    U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)

  • Project results evaluation

    Following the condition that the candidate of financial contribution was evaluated and afterwards selected by international provider in accordance with the rules of the program the Ministry of Education, Youth ans Sports does not realize the evaluation of project results. The project is evaluated only after its approval by an international provider.

Solution timeline

  • Realization period - beginning

    Jan 1, 2012

  • Realization period - end

    Nov 30, 2013

  • Project status

    U - Finished project

  • Latest support payment

    Mar 20, 2013

Data delivery to CEP

  • Confidentiality

    C - Předmět řešení projektu podléhá obchodnímu tajemství (§ 504 Občanského zákoníku), ale název projektu, cíle projektu a u ukončeného nebo zastaveného projektu zhodnocení výsledku řešení projektu (údaje P03, P04, P15, P19, P29, PN8) dodané do CEP, jsou upraveny tak, aby byly zveřejnitelné.

  • Data delivery code

    CEP14-MSM-7E-U/01:1

  • Data delivery date

    Jun 30, 2014

Finance

  • Total approved costs

    2,786 thou. CZK

  • Public financial support

    2,786 thou. CZK

  • Other public sources

    0 thou. CZK

  • Non public and foreign sources

    0 thou. CZK