Community Research and Development Information Service - CORDIS

H2020

SAMPA Report Summary

Project ID: 666795

Periodic Reporting for period 1 - SAMPA (Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application (SAMPA).)

Reporting period: 2015-07-01 to 2016-04-30

Summary of the context and overall objectives of the project

The objective of the SAMPA project is to scale up the manufacturing process of the SmPill® technology, an advanced nano-emulsion system, from current small scale up to commercial scale. SmPill® is an integrated oral drug delivery platform technology that integrates solubility, permeability and stability enhancement with targeted gastrointestinal release. The SmPill® technology requires an advanced manufacturing process that involves novel custom made equipment, proprietary nanoemulsion-based drug formulation approaches and incorporates process analytical technologies. The proprietary SmPill® drug formulation and manufacturing process will be first applied to the development and commercialisation of Sigmoid Pharma’s lead pipeline product CyCol®.

CyCol® is a proprietary SmPill®-enabled colon-targeted formulation of cyclosporine advancing into late stage clinical development for the treatment of ulcerative colitis.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Through the SAMPA project Sigmoid is working with a number of European companies to advance the scale up of the SmPill® advanced manufacturing process, including:
• a German advanced engineering and equipment manufacturing company to design, manufacture and develop customised equipment to meet Sigmoid’s specifications
• an Irish Small to Medium Enterprise (‘SME’) focused on chemical engineering solutions to permit incorporation of an upstream Process Analytical Technology (‘PAT’)
• an Irish SME focused on developing and utilising PAT instruments to monitor and control downstream processing

During the first ten months of the project Sigmoid has completed a number of activities of the work plan, including:
• Identification of the Critical Processing Parameters (‘CPP’s) of this novel process which helped inform large scale equipment design
• The performance of a number of process characterization studies with the help of pre-selected PAT tools and a range of analytical methods to define large scale equipment unit operations and further corroborate the findings in relation to the identified CPPs
• Identified a range of PAT tools to help control the scaled up process in-line and off-line
• Developed a plan for the integration the PAT tools into the large scale equipment to ensure monitoring and control of the process
• Designed, commissioned and completed factory acceptance testing on a number of bespoke pieces of GMP-standard pharmaceutical processing equipment

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Ulcerative colitis (‘UC’) affects 1 million people in Europe, 660,000 in the US and up to 1 million in the rest of the world. More than 30% of patients have disease with moderate to severe severity. The only approved option for these patients is large molecule, biologics, which are administered by injections, and are associated with serious long term side effects. The annual price of these medications may be up to €25,000 per annum. Therefore, there is a clear socio-economic benefit to successfully bring the CyCol® product to the market.

Sigmoid is developing CyCol® as an oral, cost-effective therapeutic addition to the treatment options for ulcerative colitis. CyCol® is enabled using Sigmoid’s proprietary, nano-emulsion drug delivery platform, SmPill®, which allows the targeted delivery of solubilised cyclosporine to the site of disease activity; the colon, whilst avoiding the systemic blood system. Sigmoid is designing clinical trials to evaluate whether this will be as effective and safer that other injectable biologics.

If the planned clinical trials demonstrate expected efficacy and safety, Sigmoid will apply for marketing authorisation from the appropriate regulatory authorities. If approved, Sigmoid expects significant patient demand, which can only be met if a commercial scale manufacturing capability is in place. Thus the SAMPA project plays a key role in allowing Sigmoid advance the CyCol® product to the market.

Additionally, Sigmoid has a number of other SmPill®–based products in its pipeline to treat diseases of the gastrointestinal tract and the advancement of this novel manufacturing process will open an avenue to bring these product to the market.

Related information

Record Number: 194871 / Last updated on: 2017-02-16
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