SADELProject reference: 278042
Funded under :
Scaffolds for alternative delivery
Total cost:EUR 6 482 826,07
EU contribution:EUR 4 951 792,4
Topic(s):HEALTH.2011.1.4-3 - Development and production of new, high-affinity protein scaffolds for therapeutic use
Call for proposal:FP7-HEALTH-2011-two-stageSee other projects for this call
Funding scheme:CP-FP - Small or medium-scale focused research project
The SME-based SADEL consortium intends to develop the first generation of oral bio-therapeutics tackling disease targets in the digestive tract, by making optimal use of the Nanofitin (Nf) protein scaffold. Nf based drugs will progress through routes not travelled by antibodies while interacting with targets not modulated by chemical compounds.
Existing Nf hits against validated targets will progress to the preparation of Phase I Clinical trials in Ulcerative Colitis (UC). To achieve this, SADEL assembles a virtual biopharmaceutical company with SMEs (70%), academics, clinicians and pharma industry with all cutting-edge skills: production (including GMP), analytics, formulation, preclinical and clinical development, up to licensing.
Nfs are small (optimal tissue penetration), exhibit strong resistance to pH and human intestinal fluids (long half-life in digestive track) and their high affinity implies low effective concentration. They also demonstrate strong potential for optimizing pharmacological properties, including reducing immunogenicity.
The Nf based drugs will be administered orally, reducing the systemic exposure and avoiding the safety issues reported with systemic administration of antibodies. This requires large quantities of proteins for frequent administration. Nfs are produced in bacterial systems for which GMP-compliant processes are broadly adopted in the industry, with a low cost of goods. The resulting proteins will be formulated for optimal release at the sites of action.
The project is designed to address unmet technical challenges while avoiding external risks beyond those related to the scaffold behaviour itself. All additional elements are chosen for documented validation, from targets to evaluation protocols.
Achieving SADEL aims will solve unmet patient needs by providing affordable, safe, efficient products in a format raising comfort and compliance to treatment. It will also assess the therapeutic potential of the Nanofitin platform.
EU contribution: EUR 283 613
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