NOVEL THERAPEUTIC FOR THE TREATMENT OF PARKINSONS DISEASE

Project Information

IRL790

Grant agreement ID: 835463

DOI

10.3030/835463

Project closed

EC signature date 26 November 2018

Start date 1 November 2018

End date 28 February 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

INTEGRATIVE RESEARCH LABORATORIES SWEDEN AB
Sweden

Periodic Reporting for period 1 - IRL790 (NOVEL THERAPEUTIC FOR THE TREATMENT OF PARKINSONS DISEASE)

Reporting period: 2018-11-01 to 2019-02-28

Summary of the context and overall objectives of the project

IRLAB’s goal is to develop a successful treatment that combats severe motor and psychotic symptoms in Parkinson’s disease (PD). PD is a debilitating neurodegenerative disorder affecting more than 6 million people worldwide. It is a neurological disorder with one of the highest increases in death rates, prevalence, and disability-adjusted life-years (DALYs). Levodopa, introduced more than 50 years ago, remains the most prescribed treatment for the symptomatic relief of PD, although its long-term is strongly associated to the development of motor complications, i.e. levodopa-induced dyskinesia (PD-LIDs) and psychosis in PD (PD-P). PD-P is both treatment-related and has disease-related components as well.
The overall objectives of this SME Phase 1 project were to optimise the business plan that will guide the exploitation and commercialisation of IRLAB’s novel candidate drug IRL790. It is a First in Class drug that offers improvements in both motor (LIDs) and mental (psychosis) symptom domains without exacerbating parkinsonism. Other goals were to analyse competitive landscape, prepare detailed plans for the clinical studies, and assess IRL790’s potential for the company’s growth.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The feasibility assessment included three major parts: 1) Clinical and technical feasibility evaluation, 2) Market feasibility assessment, and 3) Business Strategy Development. The overall results show that it is market-wise and clinically justified to pursue this innovation project further and enter a Phase II clinical study in PD-P patients. IRL790 is of strategic importance to IRLAB as it offers high revenue potential and its success will further strengthen the company’s growth and investment into R&D.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This feasibility study has confirmed the innovative character of IRLAB’s approach. Basing on the proprietary discovery platform, IRLAB has successfully developed a candidate drug with tremendous potential to improve intervention outcomes for PD patients with psychosis and LIDs. IRL790’s safety, toxicology and tolerability have been validated in comprehensive regulatory GLP safety and toxicology program and in Phase I clinical trials. Its therapeutic efficacy in PD-LIDs is being evaluated in an ongoing Phase II study.
Besides medical benefits to patients, IRL790 has also the potential to bring cost-savings to healthcare providers by effectively reducing Parkinson’s disease burden.

The integrative and parallel decision model of ISP, IRLAB's unique discovery platform