Description du projet
Traitement innovant de la gonarthrose précoce
La gonarthrose (GA) est une maladie dégénérative de l’articulation du genou qui touche une part importante de la population vieillissante, à hauteur de 50 % des personnes âgées de 75 ans et plus. Elle est également de plus en plus répandue chez les jeunes, les sportifs et les personnes obèses. Malheureusement, il n’existe actuellement aucune option thérapeutique pour le traitement précoce de la GA qui puisse réduire ou arrêter efficacement la progression de la maladie, évitant ainsi la nécessité d’une intervention chirurgicale. Le projet RHYP, financé par l’UE, proposera et soutiendra la commercialisation d’un nouveau produit thérapeutique prometteur appelé REG O3, pour le traitement de la GA précoce et modérée. REG O3 permet un traitement novateur et à long terme basé sur l’administration locale intra-articulaire et indolore au niveau du genou d’un médicament thérapeutique biotechnologique pour régénérer le cartilage à un tarif compétitif. Le projet prévoit un premier essai clinique chez l’homme.
Objectif
The aim of RHYP is to sustain the commercialization of a new promising therapeutic product (REG-O3) to restore the joint function for the treatment of early and moderate gonarthrosis (GA). GA is a degenerative knee joint disease that represents a huge social and economic burden worldwide. According to the World Health Organization, more than 5% of people over 40 and 50% of people over 75 years suffer specifically from GA in developed countries. It affects also a growing number of younger people as athletes and obese people, among others. There are currently no therapeutic molecules on the market for the treatment of early GA to slow down or stop disease progression and avoid surgery joint replacement. Available treatments for this disease stage are mainly symptomatic, such as the widely use injection of hyaluronic acid (HA) in articulation (viscosupplementation – Global market €1.5 Mrd in 2014). RHYP’s ambition is to tackle this current drawback by pushing forward its drug candidate REG-O3 into clinics to propose a disruptive and long-term treatment (curative and symptomatic action) using a painless local administration mode at a competitive price (€450 for total treatment is estimated).
The selected lead REG-O3 activity proof of concept on chondrocytes proliferation activation to slow down cartilage degradation was previously established in vitro and in vivo.
Following successful feasibility studies conducted thanks to the European commission (EC) through the Phase 1 of the SME Instrument, RHYP is now responding to the topic “SMEInst-03-2016-2017” in phase 2. RHYP is now aiming, during this 24 months’ project with a EC requested contribution of €2,1 M, to plug the gap from TRL 6 to TRL 9 by launching REG-O3 GMP batch manufacturing and syringes conditioning to conduct First-in-Human clinical trial. The project objective is also to prepare future partnership with identified potential licensees to conduct Clinical trials in Phase III and drug commercialization.
Champ scientifique
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SME-2 - SME instrument phase 2Coordinateur
93230 ROMAINVILLE
France
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.