IRLAB Therapeutics announced today that it has secured an additional composition of matter patent in the United States for its lead drug candidate mesdopetam, a potential treatment for Parkinson's disease. The newly granted patent specifically covers the salt form of mesdopetam intended for use in the forthcoming pharmaceutical product, as well as its manufacturing process.
This patent approval significantly strengthens the company's intellectual property position, potentially extending market exclusivity for mesdopetam well into the 2040s. The patent (US 12,275,694B2) complements IRLAB's existing substance patents already secured in major global markets.
"We are very pleased that the already strong patent protection for mesdopetam is being extended with a patent that protects a salt form of the active ingredient used in the clinical development of mesdopetam," said Kristina Torfgård, CEO of IRLAB. "The extended protection means that there is potential to extend the market exclusivity of the drug candidate all the way into the 2040s, which is incredibly positive for the value of mesdopetam."
Addressing Significant Unmet Needs in Parkinson's Disease
Mesdopetam is being developed to address a substantial unmet medical need in Parkinson's disease treatment. Specifically, the drug candidate targets levodopa-induced dyskinesias (LIDs), which are involuntary movements that develop as a side effect of long-term levodopa therapy, the standard treatment for Parkinson's disease.
According to IRLAB, LIDs affect more than 30 percent of all people living with Parkinson's disease, translating to approximately 1.5 million affected individuals across the eight major pharmaceutical markets worldwide. These dyskinesias can significantly impact quality of life and limit the effectiveness of standard Parkinson's treatments.
Strategic Patent Portfolio Expansion
The newly granted US patent is part of IRLAB's broader strategy to build comprehensive intellectual property protection for mesdopetam. The company has previously secured substance patents in all major markets globally, and the new patent provides additional layers of protection specifically for the formulation being used in clinical development.
In addition to the US patent, IRLAB recently received a corresponding patent in Australia. The company is pursuing similar patent protection in other key markets, including Europe and Japan, where if granted, exclusivity could potentially extend into the early 2040s.
Further extensions may be possible through Patent Term Extension (PTE) mechanisms, which could push exclusivity even further into the 2040s, maximizing the commercial potential of mesdopetam if it receives regulatory approval.
Clinical Development Status
While the announcement focused on patent protection rather than clinical progress, mesdopetam is IRLAB's most advanced drug candidate. The compound works through a novel mechanism of action, targeting the dopamine D3 receptor antagonist pathway.
The extended patent protection comes at a crucial time as the company continues clinical development of mesdopetam. The salt form covered by this new patent is the specific formulation being used in ongoing clinical trials, making this intellectual property particularly valuable for the company's commercialization strategy.
Market Implications
For IRLAB, a Swedish biopharmaceutical company listed on Nasdaq Stockholm, this patent extension significantly enhances the potential commercial value of mesdopetam. Extended market exclusivity is particularly important for novel therapeutics in the competitive neurology space, where development timelines are often lengthy and substantial investment is required.
The company's focus on Parkinson's disease represents a strategic approach to addressing a growing market. With an aging global population, the prevalence of Parkinson's disease is expected to increase substantially in coming decades, potentially expanding the market for effective treatments for complications like LIDs.
If mesdopetam successfully completes clinical development and receives regulatory approval, the extended patent protection would allow IRLAB to maximize returns on its investment and potentially establish the drug as a standard treatment option for Parkinson's patients suffering from levodopa-induced dyskinesias.
