Descrizione del progetto
Convalida clinica di un prodotto naturale per il trattamento dei sintomi della vescica iperattiva
La sindrome della vescica iperattiva, i cui sintomi sono urgenza urinaria e nicturia, colpisce 500 milioni di persone in tutto il mondo, con un aumento della prevalenza con l’età (> 30 % sopra i 75 anni). L’azienda islandese SagaNatura ha sviluppato NO-GO, un prodotto naturale ricavato dalle foglie di Angelica archangelica per migliorare i sintomi di tale patologia mediante un prodotto urinario senza prescrizione. La sua efficacia e la sua sicurezza sono state recentemente convalidate clinicamente in uno studio clinico su piccola scala su 66 pazienti con vescica iperattiva. L’attuale progetto di fase 2 NO-GO, finanziato dall’UE, si propone di mettere a punto la formulazione, aumentare la capacità di produzione ed estendere la convalida clinica. L’obiettivo è quello di preparare il prodotto per l’espansione nei mercati europei e nordamericani.
Obiettivo
Over Active Bladder (OAB) is a syndrome characterized by several urinary symptoms, like urgency and nocturia. Prevalence is >10% of the population, 500 million people worldwide, and increases with age (>30% over 75 years old). OAB has psychological consequences such as embarrassment, impaired social interactions, depression and anxiety. Current pharmacological treatments for OAB are associated with multiple side effects and 80% dropout rates within 1 year.
At Saga Natura we have developed NO-GO, a natural product for improving OAB symptoms, made from the leaves of the Icelandic plant Angelica archangelica.
NO-GO’s precursor SagaPro was launched on the market in 2005, becoming Iceland’s top-selling non-prescription urinary product. We have performed in vivo and in vitro characterization of SagaPro’s bladder relaxing effect and we have clinically validated SagaPro in a small-scale clinical trial on 66 OAB patients, demonstrating it’s efficiency and safety.
In Phase 2 we want to fine-tune our formulation, increase and internalize our production capacity complying with ISO and GMP standards and extend our clinical validation. We will also regulate NO-GO through the EFSA to obtain health claims. This way we will be prepared for our product’s mass expansion in Europe and in North America starting in 2021.
This project will create 21 new jobs and profits of €108 Million with ROI of 16.6 after 5 years on the market. End-users will benefit from improvement of symptoms, no side effects, and ability to lead a normal every day life. Doctors will be able to recommend NO-GO to their OAB patients, a product with no side effects, and healthcare bodies will save costs on expensive OAB prescription drugs with too high dropout rates.
Finally, with our sustainable approach for cultivating Angelica archangelica we will seize this business opportunity while also preserving the Icelandic landscape, using natural resources and minimizing the impact to the ecosystem.
Campo scientifico
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-2
Meccanismo di finanziamento
SME-2 - SME instrument phase 2Coordinatore
221 HAFNARFJORDUR
Islanda
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.