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CORDIS

A new hope for early gonarthrosis treatment using a biotechnological therapeutic drug to regenerate cartilage by intra-articular knee injection

Project description

Innovative early gonarthrosis drug treatment

Gonarthrosis (GA) is a degenerative knee joint disease that affects a significant portion of the ageing population, comprising 50 % of individuals aged 75 and older. It is also increasingly prevalent among younger individuals, athletes and the obese. Unfortunately, there are currently no available therapeutic options for early GA treatment that can effectively reduce or halt disease progression, thereby avoiding the need for surgery. The EU-funded RHYP project will propose and sustain the commercialisation of a new promising therapeutic product called REG O3, for early and moderate GA treatment. REG-O3 provides a disruptive and long-term treatment based on a painless local intra-articular knee administration of a biotechnological therapeutic drug to regenerate cartilage at a competitive price. The project will perform a first-in-human clinical trial.

Objective

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.

Call for proposal

H2020-SMEInst-2016-2017

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Sub call

H2020-SMEINST-2-2016-2017

Coordinator

REGULAXIS
Net EU contribution
€ 2 105 950,00
Address
102 AVENUE GASTON ROUSSEL BATIMENT PASTEUR SECTEUR 2169
93230 ROMAINVILLE
France

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ile-de-France Ile-de-France Seine-Saint-Denis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost
€ 3 008 500,00