IRLAB strengthens patent protection for Phase IIb/III drug candidate mesdopetam
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the World Intellectual Property Organization, WIPO, has published a new patent application concerning drug candidate mesdopetam (IRL790). This composition of matter patent may extend the market exclusivity of mesdopetam by up to eight years compared with the current patent protection. WIPO also published an International Search Report (ISR) and a patentability statement, Written Opinion (WO), in conjunction with the publication of IRLAB’s patent application. Mesdopetam is currently being evaluated in a clinical Phase IIb/III study for the treatment of levodopa-induced dyskinesias in Parkinson’s disease, PD-LIDs, with the objective to increase daily “good ON-time”.
As part of IRLAB’s continuous intellectual property work, the company has applied for a patent to strengthen the strategic protection of mesdopetam. The drug candidate mesdopetam has previously been granted patents in all major markets globally. This new published patent application relates, inter alia, to a new salt of mesdopetam that is intended to be included in the final pharmaceutical product. From the ISR and the patentability written opinion (WO), it appears as the new salt in the patent application meets the three necessary requirements; novelty, inventiveness and industrial applicability.
“The now published patent application is part of our continuous strategy to strengthen the intellectual property around our drug candidates, development portfolio and innovations. If this new patent application is granted in the forthcoming national application phases, exclusivity for mesdopetam may be protected by two strong patent families into the 2040s, benefitting patients and other stakeholders,” says Nicholas Waters, CEO at IRLAB.
The ongoing clinical Phase IIb/III study with mesdopetam is a randomized, double-blind and placebo-controlled study with the aim of evaluating the effect of mesdopetam in patients with Parkinson’s disease affected by troublesome dyskinesias. The study has started in the US and parallel application processes to regulatory authorities and ethics committees are ongoing in selected European countries.
For more information
Nicholas Waters, CEO
Phone: +46 730 75 77 01
Mesdopetam (IRL790) is a dopamine D3 receptor antagonist in development for the treatment of PD-LIDs, troublesome dyskinesias commonly occurring after treatment with levodopa, and psychosis in Parkinson’s disease. In preclinical and initial clinical studies, mesdopetam reduces troublesome dyskinesia by increasing “Good ON” that occurs after treatment with levodopa. Analysis of the data from the recently completed Phase IIa study showed a dose dependent improvement of this measure. Patients treated with mesdopetam 7,5 mg twice daily had, on average, 5.6 hours longer Good ON compared with 1 hour in the placebo group (p<0,002). Additionally, in preclinical studies, mesdopetam has also shown antipsychotic properties. IRLAB believes that mesdopetam thus has the potential to simultaneously treat both troublesome dyskinesias and psychosis in Parkinson’s disease.
IRLAB is a Swedish research and development company that focuses on developing novel treatments in Parkinson’s disease. The company's most advanced candidates, mesdopetam (IRL790) and pirepemat (IRL752), both of which completed Phase IIa-studies, intends to treat some of the most difficult symptoms related to Parkinson's disease: involuntary movements (PD-LIDs), psychosis (PD-P) and symptoms linked to cognitive decline such as impaired balance and increased risk of falls (PD-Falls). Through the proprietary research platform, ISP (The Integrative Screening Process), IRLAB discovers and develops unique drug candidates for central nervous system (CNS) related disorders where large and growing medical need exist. In addition to the clinical candidates, the ISP platform has also generated several CNS programs that are now in preclinical phase. IRLAB is listed on Nasdaq Stockholm Main Market. More information on www.irlab.se.