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Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application (SAMPA).

Objective

Sigmoid Pharma has developed an innovative product, CyCol®, to treat patients with moderate-severe ulcerative colitis, a disease that affects 1 million patients in Europe. CyCol® is enabled using Sigmoid’s proprietary SmPill® nanoemulsion-based technology to target a known and powerful drug, cyclosporine, directly to inflamed colons. In Phase II human studies, CyCol® was proven to be effective and safe. CyCol®, on oral product, will compete with injected, expensive drugs that have a risk of serious side effects.

Successful development and commercialisation of CyCol® will pivot on scaling up the advanced manufacturing process from the current ~5kg to the ~50kg batch size required for Phase III human studies.

SAMPA (Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application) project is focused on achieving 50kg batches. It will involve leading EU-based specialist SME technology and equipment suppliers as well as a number of knowledge providers. The requested budget is €1.6M and will be completed in 21 months.

Successful completion of this project will retain and enhance intellectual property and know-how in Sigmoid, increase long term high skill jobs. In parallel, the project will unlock the value inherent not only of CyCol®, but also the underlying SmPill® technology platform. Furthermore, the project will increase the probability of overall company success and increase significantly the NPV to more than €500M.

Field of science

  • /medical and health sciences/clinical medicine/gastroenterology/inflammatory bowel disease
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /engineering and technology/chemical engineering

Call for proposal

H2020-SMEINST-2-2014
See other projects for this call

Funding Scheme

SME-2 - SME instrument phase 2

Coordinator

SIGMOID PHARMA LIMITED
Address
The Invent Centre, Dublin City University
9 Dublin
Ireland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 600 000