Periodic Reporting for period 4 - RHYP (A new hope for early gonarthrosis treatment using a biotechnological therapeutic drug to regenerate cartilage by intra-articular knee injection)
Período documentado: 2019-12-01 hasta 2020-11-30
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 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.
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.
Since the beginning of the project, we have prepared the production of the GMP batch by the industrial transposition of the processes. For this, we realized "pre-GMP" batches, developed the purification process and the formulation, and performed an important part of stability studies.
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.
Numerous presentations of this project were made to the scientific community, key stakeholders and the general public.
Unfortunately, the Covid-19 period slowed down our development and stopped the entry of investors. The project could not be finalized within the allotted time.
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.
Numerous presentations of this project were made to the scientific community, key stakeholders and the general public.
Unfortunately, the Covid-19 period slowed down our development and stopped the entry of investors. The project could not be finalized within the allotted time.
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.
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.