Periodic Reporting for period 2 - ARTRIGEL (Development of a Complete Triple Action Injectable Treatment for Osteoarthritis)
Período documentado: 2023-03-01 hasta 2024-08-31
Context: Osteoarthritis (OA) is an incurable complex disease affecting an estimated 250 million people globally including 40 million Europeans. In knee OA progressive degradation of bone and cartilage in the joint results in severe pain and reduced mobility. Current treatments for knee OA target only one aspect of the disease, yet most recent scientific data highlight the need for multi-modal therapeutics to treat this complex disease.
Project Summary: During the course of the project, ARTRIGEL will generate data in a wide range of R&D activities from prototype synthesis and characterisation to in-vitro and in-vivo screening and testing. In addition, ancillary data will be generated on downstream activities such as regulatory and clinical strategies. It is important these data are collected, documented, and disseminated in a timely fashion and to the appropriate audience.
Project Scope: ARTRIGEL is a 2-year research and innovation project that aims to develop a disruptive new injectable biotherapeutic treatment for knee osteoarthritis. This treatment called Hydrobloc offers superior pain relief with lubrication and protective effects. The project has four main outcomes planned over six work packages:
• Optimisation of the prototypes to give maximum pain-relieving effects, and test for these results.
• Screening of the treatment for additional OA indications (hip and spine) and demonstrating that the positive results from the small animal model can translate into a large animal model.
• Completion of an IND/CTA file to apply for approval of Phase 1 clinical trial.
• Securing private investment and/or EIC Accelerator grant to transition and progress the treatment along the regulatory pathway to commercialisation roadmap.
Project Summary: During the course of the project, ARTRIGEL will generate data in a wide range of R&D activities from prototype synthesis and characterisation to in-vitro and in-vivo screening and testing. In addition, ancillary data will be generated on downstream activities such as regulatory and clinical strategies. It is important these data are collected, documented, and disseminated in a timely fashion and to the appropriate audience.
Project Scope: ARTRIGEL is a 2-year research and innovation project that aims to develop a disruptive new injectable biotherapeutic treatment for knee osteoarthritis. This treatment called Hydrobloc offers superior pain relief with lubrication and protective effects. The project has four main outcomes planned over six work packages:
• Optimisation of the prototypes to give maximum pain-relieving effects, and test for these results.
• Screening of the treatment for additional OA indications (hip and spine) and demonstrating that the positive results from the small animal model can translate into a large animal model.
• Completion of an IND/CTA file to apply for approval of Phase 1 clinical trial.
• Securing private investment and/or EIC Accelerator grant to transition and progress the treatment along the regulatory pathway to commercialisation roadmap.
Activities performed and main achievements in each work package (WP):
• WP1: All tasks, reports, and related deliverables were completed on track and within allocated budget.
• WP2: The team synthesised the first and second generations of prototypes; synthesis was optimised for scalability, repeatability, and reproducibility. Extensive physicochemical testing was performed to characterise these novel prototypes. In-vitro cell models were optimised to measure safety, efficacy, and release kinetics of Hydrobloc prototypes.
• WP3: The preclinical testing protocols were designed to assess the safety and efficacy of Hydrobloc. In the rodent OA model, Hydrobloc demonstrated excellent safety signal with prolonged knee pain-relieving effect. Safety of Hydrobloc was also established in a large animal species.
• WP4-WP6: Engaged with appropriate regulatory, clinical, and financial partners to take Hydrobloc through the commercialisation pathway.
• WP1: All tasks, reports, and related deliverables were completed on track and within allocated budget.
• WP2: The team synthesised the first and second generations of prototypes; synthesis was optimised for scalability, repeatability, and reproducibility. Extensive physicochemical testing was performed to characterise these novel prototypes. In-vitro cell models were optimised to measure safety, efficacy, and release kinetics of Hydrobloc prototypes.
• WP3: The preclinical testing protocols were designed to assess the safety and efficacy of Hydrobloc. In the rodent OA model, Hydrobloc demonstrated excellent safety signal with prolonged knee pain-relieving effect. Safety of Hydrobloc was also established in a large animal species.
• WP4-WP6: Engaged with appropriate regulatory, clinical, and financial partners to take Hydrobloc through the commercialisation pathway.
The overall goal of the project is to progress the development of a life-transforming treatment for people living with knee OA. The impact of achieving this goal is far-reaching.
Scientific impact: Publish all new scientific discoveries in high impact journals. Patent filing on the new discoveries and continuously expanding our IP portfolio.
Economic impact: The company has already spun out with plans to further expand its workforce.
Societal impact: The treatment developed by the ARTRIGEL team have the potential to provide highly effective, long-lasting pain relief addressing the shortcomings of current treatments, where people living with the disease can maintain a good quality of life.
Scientific impact: Publish all new scientific discoveries in high impact journals. Patent filing on the new discoveries and continuously expanding our IP portfolio.
Economic impact: The company has already spun out with plans to further expand its workforce.
Societal impact: The treatment developed by the ARTRIGEL team have the potential to provide highly effective, long-lasting pain relief addressing the shortcomings of current treatments, where people living with the disease can maintain a good quality of life.