IRLAB Therapeutics has announced the grant of a new patent in Europe, Japan, and China for its drug candidate pirepemat, strengthening the intellectual property protection for this potential first-in-class treatment for falls in Parkinson's disease. The patent covers both a new salt formulation of pirepemat and its manufacturing process, specifically protecting the active pharmaceutical ingredient (API) currently being used in ongoing Phase IIb clinical trials.
"With this patent, IRLAB is adding to the already strong patent protection for one of its lead programs, pirepemat, providing further exclusivity and adding to the value of the pirepemat program. This is a key factor in partnering and commercialization discussions," said Gunnar Olsson, CEO of IRLAB.
Extended Market Exclusivity
The newly granted patent complements existing composition of matter patents for pirepemat in major markets including China, the European Union, Japan, and the United States. This additional layer of protection is expected to extend exclusivity until 2038, with potential supplementary protection certificates (SPCs) or patent term extensions (PTEs) potentially pushing market exclusivity into the early 2040s.
This strategic patent expansion comes at a critical time as the company advances its clinical development program and explores commercialization partnerships.
Addressing a Critical Unmet Need in Parkinson's Disease
Pirepemat (IRL752) is being developed to address one of the most debilitating aspects of Parkinson's disease - the high incidence of falls. According to IRLAB, approximately 45 percent of all people living with Parkinson's disease experience recurrent falls, representing about 2.6 million patients globally. These falls significantly reduce quality of life and create persistent fear of falling among patients.
Despite this substantial medical need, there are currently no approved treatments specifically targeting fall prevention in Parkinson's disease.
Novel Mechanism of Action
What distinguishes pirepemat from other Parkinson's therapies is its unique mechanism of action. The drug is designed to strengthen nerve cell signaling in the prefrontal cortex through antagonism at 5HT7 and alpha-2 receptors, which leads to increased dopamine and noradrenaline levels. This approach specifically targets the balance and postural stability issues that contribute to falls in Parkinson's patients.
Current Clinical Development Status
Pirepemat is currently being evaluated in a Phase IIb clinical trial across 38 study sites in six European countries: France, Germany, Poland, the Netherlands, Spain, and Sweden. The study aims to assess the efficacy, safety, and tolerability of different doses to identify the optimal regimen for future Phase III trials.
The trial represents a significant step toward potentially introducing the first treatment specifically designed to reduce falls and fall-related injuries in the Parkinson's population.
Market Implications
If successful in clinical trials and subsequently approved, pirepemat would enter a market with significant unmet needs. The extended patent protection now secured in key global markets positions IRLAB favorably for potential licensing agreements or partnerships as the company progresses toward late-stage development.
The company's focus on fall prevention addresses a specific aspect of Parkinson's disease that has substantial clinical and economic implications, including hospitalization costs from fall-related injuries and the broader impact on patient independence and quality of life.
As the Phase IIb study continues to enroll and treat patients, the strengthened patent position provides additional security for IRLAB's continued investment in this promising therapeutic approach for a debilitating aspect of Parkinson's disease that currently lacks effective treatment options.
