A novel drug candidate for the treatment of Eosinophilic Esophagitis - an innovative solution for a significant unmet medical need

Información del proyecto

theEoE

Identificador del acuerdo de subvención: 745175

DOI

10.3030/745175

Proyecto cerrado

Fecha de la firma de la CE 26 Noviembre 2016

Fecha de inicio 1 Diciembre 2016

Fecha de finalización 30 Abril 2017

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

THELIAL TECHNOLOGIES SA
Portugal

Periodic Reporting for period 1 - theEoE (A novel drug candidate for the treatment of Eosinophilic Esophagitis - an innovative solution for a significant unmet medical need)

Período documentado: 2016-12-01 hasta 2017-04-30

Resumen del contexto y de los objetivos generales del proyecto

EoE is a chronic inflammatory disease wherein a certain variety of white blood cell (eosinophils) build up in the esophagus. esophagealand the disease commonly results in narrowing of the esophageal passage, also known as stricture. This can cause difficulties in swallowing food or even cause outright blockages when food becomes trapped in the passage (also known as impaction).
Thelial presents The1, the first orphan drug developed through their drug discovery platform, theLiTE™ (Thelial Live Targeted Epithelia). As the first drug specifically to treat EoE, with a notable reduction in side effects, The1 is an immediate improvement on the state of the art. The1 reduces the clinical symptoms, modifies disease progression through tissue remodelling, and increases the duration of treatment response. These features will allow physicians, patients and payers to benefit from a revolutionary new treatment with fewer side effects, and lower risk of health complications thanks to better long-term management of the condition over time.
Thelial’s pre-clinical programme focuses on development of The1 as a drug, which can then be used to support the validation and viability of TheLiTE™ as a platform for further underserviced diseases.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

Deepen the study on the requirements and standards for medical devices and define a minimum viable product for the discovery platform’s outputs: basic information e.g. drug delivery method decided. Liquid medium – syrup. Prescription information to be decided based on results of pre-clinical trials.
Plan feasible product development from current readiness level to TRL9 for The1: Pre-clinical programme devised. Clinical programme outlined. Post-clinical trial activities identified.
Outline pre-clinical programme: Pre-clinical trial activities identified, impact on future developments elaborated. Quote summary in Appendix 1.
Establish a feasible industrialisation plan (large scale production process) and elaborate the business full operations: regulations identified for EU & US market entry, value chain outlined.
Risk assessment & Contingency Plan: main risks identified and proper counteractions planned.
Scout and identify EU industrial partners (SMEs/Large Enterprises) in the supply/value chain, and all institutional / medical stakeholders influencing the success of commercialisation: all identified profiles/stakeholders contacted and pre-clinical programme stakeholders contacted.
Size the reachable customers and a reliable market share: qualitative and quantitative results shown from comprehensive analysis of customers and entry barriers.
Commercial viability check (establish a sound Go-to-market Strategy) and development of a suitable Marketing & Communication strategy: securing the interest for the project and further cooperation of a
CRO/CMO.
Accomplish 5-years financial projections.
Establish an effective IP management strategy: identify a comprehensive IP management strategy including protection methods (patent, trademark, trade secret, etc.).

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

In contrast, Thelial presents The1, the first orphan drug developed through their drug discovery platform, theLiTE™ (Thelial Live Targeted Epithelia). As the first drug specifically to treat EoE, with a notable reduction in side effects, The1 is an immediate improvement on the state of the art. Extracted from plant matter, The1 is delivered orally, in a syrup format. The syrup dose should be followed ~30 minutes later with water to clear the mouth of any residue, without compromising effectiveness of the dose. The1 reduces the clinical symptoms, modifies disease progression through tissue remodelling, and increases the duration of treatment response. These features will allow physicians, patients and payers to benefit from a revolutionary new treatment with fewer side effects, and lower risk of health complications thanks to better long-term management of the condition over time.

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