Pirepemat (IRL752) is being developed to improve balance and reduce falls, and thus injuries from falls, in people living with Parkinson’s. Falls are a significant consequence of Parkinson’s that has severe complications, such as fractures, impaired mobility and reduced quality of life. Impaired balance and falls are linked to cognitive decline and the progression of Parkinson’s disease.
45 percent of all people with Parkinson’s fall recurrently, leading to a significantly reduced quality of life due to a fear of falling affecting their daily life. There are no available treatments at present despite it representing a great unmet medical need. The societal burden for falls is also significant with the cost of treatment for a fall injury in the US is estimated to be USD 30 thousand in people over the age of 65.
Pirepemat is designed to improve balance and reduce falls by strengthening nerve cell signalling in the prefrontal cortex via action at 5HT7 and alpha-2 receptors. Pirepemat also has potential as a treatment for dementia in Parkinson’s disease (PD-D).
Following successful completion of Phase I studies, an exploratory Phase IIa study was completed in 32 patients with advanced Parkinson’s including cognitive impairment. Pirepemat was found well tolerated in this patient population. Compelling treatment effects were reported indicating improvement in balance and reduced risk of falling, in concert with cognitive and psychiatric benefits. These results suggest that pirepemat has the potential to strengthen the frontal cortical function and be a valuable, first-of-its-kind treatment to prevent falls in people living with Parkinson’s.
Ongoing Phase IIb study
The Phase IIb study of pirepemat is a randomized, double-blind, and placebo-controlled study with the aim to evaluate the efficacy, safety, and tolerability of different doses of pirepemat in people living with Parkinson’s disease in order to identify the optimal dose for Phase III. Besides safety and tolerability, the study objectives are to evaluate the effect of pirepemat on falls frequency, postural dysfunction, cognitive function, and symptoms of Parkinson’s disease in people living with Parkinson’s disease. The study is active at 38 study sites across France, Germany, Poland, the Netherlands, Spain, and Sweden.
More information can be found on EudraCT number: 2019-002627-16 and clinicaltrials.gov: NCT05258071.
About the recommended INN, pirepemat
Since August 2020, IRL725 goes by the International Nonproprietary Name (INN), pirepemat. The World Health Organization (WHO) concluded that IRL752 should not be incorporated into any existing INN stem in the classification system. IRL752 therefore has the potential to becoming a first-in-class treatment. The INN will serve to identify the active pharmaceutical substance of pirepemat during its lifetime worldwide.
Strong intellectual property rights
Exclusivity based on patents
A substance patent covering pirepemat 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 directed to a new salt of pirepemat and processes for preparing has been granted and will expire in 2038.
Potential grants of supplementary protection certificate (SPC) or patent term extension (PTE), exclusivity can potentially reach into the 2040s for pirepemat.*
Exclusivity based on regulatory data protection
Independent of the patent-based exclusivity periods pirepemat will also enjoy customary market exclusivity, for ten years from market approval in Europe and five years from market approval in the US, based on regulatory data exclusivity as a new chemical entity (NCE).
* A medicinal product can only be granted an SPC/PTE extension for one patent.