The drug candidate IRL752 aims to treat impaired balance (postural dysfunction) which contributes to a markedly enhanced risk for falls in patients with Parkinson’s disease (PD). Associated with cognitive decline, falls are a debilitating problem, leading to serious complications such as fractures, decreased mobility and lower quality of life. IRL752 is in clinical Phase II development stage.
Postural dysfunction is a major problem patients with PD where approximately 60% of patients fall every year. The risk of falling for a patient with PD is 2-3 times higher as compared to age matched controls. There are currently no approved treatments aimed specifically to reduce the risk of falling for patients with PD.
IRL752 increases cortical neurotransmitters
The IRL752 molecule enables an increase in the levels of the neurotransmitters dopamine and noradrenaline in the nerve connections of the cerebral cortex, thereby strengthening signal transfer, particularly in the frontal lobes. The frontal lobes are essential for functions such as abstract reasoning, decision-making, working memory, emotions, behavior and personality and control functions such as:
- Impulse control and attention
- Working memory and cognitive flexibility
- Regulation of brain centers that maintain upright balance and postural reactions to prevent falls
In advanced stages of PD, there is a progressive decline in cognitive functions, which often occurrs in parallel with impairment of so-called axial motor functions, including impaired balance (postural dysfunction) and increased risk of falling.
In a clinical Phase II program
IRL752 is in a Phase II clinical development program and has demonstrated good safety and tolerability in healthy volunteers and in PD patients from Phase I and Phase IIa studies. The study results show promising improvements in axial motor symptoms such as postural instability and falls as well as apathy and cognitive impairment in PD patients. IRLAB is currently planning for a Phase IIb study to further evaluate the effects of the drug candidate on falls frequency in PD patients.
Strong intellectual property rights
A substance patent covering the IRL752 molecule and its analogues has been approved in all major markets across the globe. Provided the regulatory requirements are met, the patent protection can be extended at most until 2035 in the US and until 2034 in Japan and Europe.
A new patent application directed to a new salt of IRL752 and processes for preparing it was filed in 2018. Patents granted based on this application will expire in 2038.
IRL752 will enjoy market exclusivity as a new chemical compound, for ten years from market approval in Europe and five years from market approval in the US.
Ready for large-scale manufacture
In parallel with clinical development, manufacturing methods and quality assurance for production of the active substance (API), known as Chemistry, Manufacturing and Controls (CMC) have been optimized for IRL752, and production has been scaled up. The purpose is to prepare for future clinical studies in accordance with authority requirements and guidelines.