70 lakh people suffer from Parkinson’s in India; `IRL757' shows promise in treating nonmotor condition

Gothenburg, Sweden: A new drug candidate has shown a potential to offer effective treatment for `apathy’, a non-motor condition in patients suffering from Parkinson’s disease. The condition is characterized by a lack of interest and motivation in activities.

`Scientists pin high hopes on 'IRL757’ which is being developed in Sweden.

IRLAB Therapeutics AB, a Sweden-based company discovering and developing novel treatments for Parkinson’s disease, has been awarded USD 2 million by `The Michael J. Fox Foundation’ ((MJFF) to further the drug research.

Grant given for Phase 1 clinical trial

The grant will be used to conduct the first-in-man Phase I clinical study of IRL757, a drug candidate in development as a novel treatment for apathy. An effective treatment for apathy, both in Parkinson’s disease and in other neurological disorders, can transform the lives of millions of people who are left without effective treatment today.

The drug candidate IRL757 has completed all preclinical studies and development work necessary to start Phase I. The clinical trial application (CTA) to be submitted to the regulatory authority is currently being prepared.

The grant was awarded under MJFF’s programme ‘Parkinson’s disease Therapeutics Pipeline Programme.’ This programme seeks to advance preclinical and/or clinical testing of promising therapeutic developments that address unmet medical needs in people with Parkinson’s disease.

“IRLAB’s novel approach to treating apathy has the potential to alter an impactful symptom for people affected by Parkinson’s – both patients and families – offering relief where it is currently difficult to find. We look forward to seeing this research progress,” said MJFF’s senior vice president of Clinical Research Catherine Kopil.

“We see this grant as an expression of confidence in our innovative approach to tackling unmet needs, including apathy, in Parkinson’s disease. With MJFF’s support, we are positioned to advance IRL757 through a crucial Phase I study,” said Gunnar Olsson, CEO, IRLAB.

About IRL757

The drug candidate IRL757 is being developed as a treatment for apathy in Parkinson’s disease and other neurological conditions. Apathy, a widespread and debilitating issue, affects over 20 million people in the US and Europe alone without a currently available treatment. RL757 has the potential to become the first treatment for apathy. IRL757 has shown promising results in various preclinical models, which assess different aspects of cognitive function and motivation. The observed efficacy of IRL757 is thought to be linked to its unique ability to reverse disruption in cortical to sub-cortical (related to cerebral cortex) nerve signaling, a key factor believed to contribute to apathy in neurological disorders.

Parkinson’s burden in India

The neurological degenerative disorder Parkinson’s Disease (PD) affects 70 per lakh people in India, which means there are over seven million or 70 lakh estimated patients with PD in the country. Reportedly, as of 2019, nearly nine million people in the world, and 1% of those above 60 years old are found to be affected with PD.

In patients suffering from Parkinson’s Disease, the dopamine-producing cells of the Central Nervous System (CNS) degenerate, which leads to loss of muscle function, chronic and progressive movement disorders including tremors in limbs, difficulty in movement, impaired balance, etc.

Disease burden to increase with higher geriatric population

Though PD cannot be cured, treatment with medication, physical therapy, and/or surgery can help arrest the progress of the disease and manage the symptoms. Though the prevalence of PD in India is less compared to other countries, the total burden of PD turns out to be much higher due to a huge population. With an average increase in life span, the geriatric population has also increased and they are the ones more susceptible to PD. The disease burden is expected to increase even more in the coming decades putting a severe strain on the economy and healthcare services.

Findings from Indian studies on PD

‘Research in Parkinson’s disease in India: A review’ published in PubMed Central in 2016, which was written by researchers from the Department of Neurology at NIMHANS said, “In a door-to-door survey done in Bangalore district in South Karnataka in India in 2004, the prevalence rate of Parkinsonism was found to be 33 per 100,000 (crude prevalence) and 76 per 100,000 (age-adjusted).”

“Rural population had a higher prevalence compared to the urban population. In most studies, it has been found that women have a lesser prevalence of PD. Different studies pointed to the PD prevalence rate varying in different states and among ethnic groups,” the authors of the study observed. The researchers included Pratibha Surathi, Ketan Jhunjhunwala, Ravi Yadav, and Pramod Kumar Pal.

Risk Factors and Symptoms

Risk factors include a family history of PD and a previous history of depression. Environmental risk factors such as rural living, drinking well water, farming, and pesticide exposure have been attributed to different studies. Genetic PD, found in less than 10% of PD patients, is caused by the single gene Mendelian disorder.

Cardiovascular symptoms, respiratory dysfunction, perceptual problems, hallucinations, cognition issues, speech impairment, Restless leg syndrome (RLS), mood changes, anxiety, and sleep disturbances were significantly more in PD patients. Postural imbalance forms one of the important features of PD while memory disturbances and dementia are known to occur in later stages of PD.