A novel ulcerative colitis treatment - A phase III ready feasibility study | UCRxF | Project | Fact sheet | H2020 | CORDIS

Projektbeschreibung

Ein biologisches Arzneimittel gegen Colitis ulcerosa

Die Colitis ulcerosa ist mit einer langfristigen Entzündung des Dickdarms verbunden, die Bauchschmerzen und Durchfall verursacht. Das EU-finanzierte Projekt UCRxF schlägt Cobitolimod vor, ein neuartiges Medikament auf DNA-Basis zur Behandlung von Colitis ulcerosa, das einen neuartigen Wirkmechanismus besitzt und den Toll-like-Rezeptor 9 (TLR9) aktiviert. Zu den nachgeschalteten Effekten der TLR9-Aktivierung gehören die Heilung von Geschwüren und die Verringerung von Schleimhautentzündungen. Erste Ergebnisse aus klinischen Studien hinsichtlich der Sicherheit und Wirksamkeit von Cobitolimod sind ermutigend. Zu den Tätigkeiten von UCRxF gehören die toxikologische Bewertung des Arzneimittels und ein verbesserter Herstellungsprozess vor der Einleitung der klinischen Phase III.

Ziel

InDex Pharmaceuticals AB is a pharmaceutical development company based at the Karolinska Institutet Science Park in Stockholm, Sweden. The company´s primary asset is cobitolimod, which is in late phase clinical development as a new medication to treat moderate to severe active ulcerative colitis (UC); a chronic, debilitating disease with a high unmet medical need. UC is caused by chronic inflammation of the colon, and there is no cure.

Cobitolimod offers a novel and unique mechanism of action for the treatment of UC, and has demonstrated a higher efficacy and better safety profile in clinical studies than what has been reported for currently approved biological drugs. Cobitolimod is part of the broad InDex portfolio of DNA-based ImmunoModulatory Sequences (referred to as DIMS), which have the potential for treatment of various immunological diseases. Cobitolimod is currently being tested in a phase IIb clinical study with top line results expected in Q4 2018.

InDex’s business strategy is to out-license cobitolimod to a larger international pharmaceutical company prior to the initiation of clinical phase III development. This will generate revenues for InDex from upfront and milestone payments as well as royalties from third party sales, which can then be reinvested in the company to finance development of new compounds from the DIMS technology platform.

For clinical phase III, additional manufacturing and toxicology work as well as commercial preparations are essential. The planning and preparation of this work is the purpose of this feasibility study, which is a crucial part of the cobitolimod phase III ready programme, increasing the attractiveness of the asset in partnering discussions with pharmaceutical companies looking for innovative new products. A licensing deal will ensure that the development of this promising, innovative drug will continue in a fast and efficient way to reach patients with this debilitating disease.

Wissenschaftliches Gebiet

Programm/Programme

Thema/Themen

EIC-SMEInst-2018-2020 - SME instrument

Aufforderung zur Vorschlagseinreichung

H2020-EIC-SMEInst-2018-2020

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEInst-2018-2020-1

Finanzierungsplan

SME-1 - SME instrument phase 1

Koordinator

INDEX PHARMACEUTICALS AB

Netto-EU-Beitrag

€ 50 000,00

Adresse

TOMTEBODAVAGEN 23A
171 77 STOCKHOLM
Schweden

KMU

Ja

Region

Östra Sverige Stockholm Stockholms län

Aktivitätstyp

Private for-profit entities (excluding Higher or Secondary Education Establishments)

Links

Die Organisation kontaktieren

Teilnahme an EU-FuI-Programmen

HORIZON-Kooperationsnetzwerk

Gesamtkosten

€ 71 429,00

A novel ulcerative colitis treatment - A phase III ready feasibility study