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

Objective

Sublimity Therapeutics has developed an innovative product, ST-0529, to treat patients with moderate-severe Ulcerative Colitis, a disease that affects 1 million patients in Europe. ST-0529 is enabled using Sublimity Therapeutics ’s proprietary SmPill® nanoemulsion-based technology to target a known and powerful drug, Cyclosporine, directly to inflamed colons. In Phase II human studies, ST-0529 was proven to be effective and safe. ST-0529, an oral product, will compete with injected, expensive drugs that have a risk of serious side effects.

Successful development and commercialisation of ST-0529 will pivot on development of a stable ST-0529 product and a positive outcome of the clinical trials.
Overall, the project will involve leading EU-based specialist SME, technology and equipment suppliers as well as a number of knowledge providers. The budget is €1.6M and will be completed in 58 months.
Successful completion of this project will retain and enhance intellectual property and know-how in Sublimity Therapeutics, increase long term high skill jobs. In parallel, the project will unlock the value inherent not only of ST-0529, 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.

Call for proposal

H2020-SMEInst-2014-2015

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Sub call

H2020-SMEINST-2-2014

Coordinator

SUBLIMITY THERAPEUTICS LIMITED
Net EU contribution
€ 1 600 000,00
Address
Invent Centre Dublin City University
9 Dublin
Ireland

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Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 707 500,00