Periodic Reporting for period 3 - RHYP (A new hope for early gonarthrosis treatment using a biotechnological therapeutic drug to regenerate cartilage by intra-articular knee injection)
Reporting period: 2019-03-01 to 2019-11-30
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 30 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.
These first batches enabled us to carry out toxicity studies preliminary to the regulatory studies and PK/PD studies. All results obtained are particularly encouraging.
Three GMP batchs was finalized with all the associated regulatory documentations and we study the stability of these GMP batchs.
During this period, several presentations of this project were made to the scientific community, key stakeholders and general public."
Some similar (two main) projects on chemical molecules to treat osteoarthritis are currently under development in the world. However, none has yet arrived on the market.
The marketing of this drug will permit to improve the quality of life of 854 000 EU citizens (8.5 million of persons worldwide, estimated to reach 13.5 million in 2023) and sustain healthy and active ageing by keeping older (and a growing number of younger) people active and independent for longer. We aim to divided, at least, by 3 the total economic burden of OA.