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Biopharmaceutical therapy for treatment of Primary Hyperoxaluria

Biopharmaceutical therapy for treatment of Primary Hyperoxaluria

Objective

Interest in the use of naturally occurring human gut bacteria as pharmaceutical drugs has increased as knowledge about the human microbiota and its role in health and disease has advanced.
The ELIMOX project proposes to develop a new drug from Oxalobacter formigenes, an anaerobic bacterium whose only carbon source is oxalate, for the treatment of primary hyperoxaluria (PH). PH is a rare and life-threatening disease, present at birth, characterised by high endogenous levels of oxalate that damage the kidney and cause renal failure. Enteric elimination of oxalate via the gut provide an alternative elimination pathway for the oxalate and treatment with pharmacological doses of O. formigenes would facilitate such enteric elimination. The treatment employs a new approach whereby bacterial breakdown of excessive oxalate occurs in the gut, inducing an alternative pathway for the oxalate, thereby protecting the kidneys from failure. The O. formigenes approach to treat PH is an ideal model for bacterial treatment of metabolic disease.
The three SME participants will utilise the expertise of nine specialised research providers to increase the understanding of the characteristics of the sensitive, anaerobic and highly specialised O. formigenes, to implement the manufacturing process to obtain a clinically effective drug, to optimise drug delivery and to develop specialised analytical methods to monitor clinical effects following treatment. Technology advancements will be confirmed by clinical studies in PH patients and by mapping the presence of the bacteria before and after treatment with the O. formigenes drug.
The ELIMOX project will advance current standards and methodology in i) manufacture of anaerobic bacteria for pharmaceutical use, ii) identification, quantification and tracking of microbes in the human gut and their impact on human microbiota during treatment, iii) optimisation of tools to monitor clinical effects during treatment with anaerobic bacteria.
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Coordinator

OXTHERA AB

Address

Sturegatan 56
11436 Stockholm

Sweden

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

EU Contribution

€ 1 262 792

Administrative Contact

Elisabeth Lindner (Ms.)

Participants (11)

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COBRA BIOLOGICS LIMITED

United Kingdom

EU Contribution

€ 579 199

SYMBIO PHARM GMBH

Germany

EU Contribution

€ 340 007

ERGOMED CLINICAL RESEARCH LIMITED

United Kingdom

UNIVERSITAETSKLINIKUM BONN

Germany

EU Contribution

€ 2 000

HOSPICES CIVILS DE LYON

France

EU Contribution

€ 5 040

UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 1 960

GALENICA AB

Sweden

K.A.B.S. LABORATORIES INC. - KABS

Canada

MEDIZINISCHES VERSORGUNGSZENTRUM INSTITUT FUR MIKROOKOLOGIE GMBH

Germany

NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO

Netherlands

BIO-IMAGES RESEARCH LIMITED

United Kingdom

Project information

Grant agreement ID: 606528

Status

Closed project

  • Start date

    1 October 2013

  • End date

    30 September 2016

Funded under:

FP7-SME

  • Overall budget:

    € 2 789 039

  • EU contribution

    € 2 190 998

Coordinated by:

OXTHERA AB

Sweden