Poxel Secures New Patent in Japan for Imeglimin’s Use in Type 2 Diabetes Patients with Renal Impairment
POXEL SA (Euronext: POXEL – FR0012432516), a clinical-stage biopharmaceutical company specializing in innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, has announced the grant of a new patent by the Japanese Patent Office. The patent (n°7635474) covers the use of Imeglimin, marketed as TWYMEEG®, in type 2 diabetic patients with moderate to severe renal impairment. This patent protection extends until 2039, reinforcing TWYMEEG®’s intellectual property portfolio in Japan and positioning it as a key therapeutic option for this underserved patient population.
Expanding Treatment Options for Diabetic Patients with Renal Impairment
The newly granted patent comes at a pivotal time as Sumitomo Pharma, Poxel’s partner in Japan, engages in discussions with regulatory authorities to revise the TWYMEEG® package insert. The goal is to include usage guidelines for type 2 diabetes patients with renal impairment who have an estimated glomerular filtration rate (eGFR) of less than 45 mL/min/1.73m². If approved, this update would significantly broaden the scope of TWYMEEG®’s application, addressing a critical unmet medical need.
Renal impairment is a common comorbidity in type 2 diabetes, affecting a substantial portion of patients and complicating treatment options. Many existing therapies are either contraindicated or require dose adjustments for patients with reduced kidney function, leaving them with limited safe and effective alternatives. By securing this patent, Poxel strengthens its commitment to providing innovative solutions for this vulnerable population.
Strengthening Imeglimin’s Global Footprint
This patent approval in Japan follows a similar grant in China, the world’s second-largest market for type 2 diabetes treatments. The dual patent approvals underscore the growing interest in Imeglimin beyond Japan and highlight Poxel’s efforts to expand its reach into other key Asian markets. These developments also bolster ongoing discussions initiated by Poxel to explore opportunities for developing Imeglimin in additional regions, further solidifying its position as a promising therapy in the global diabetes landscape.
Thomas Kuhn, Chief Executive Officer of Poxel, emphasized the significance of this milestone: “This new patent approval in Japan is an important step forward that enhances TWYMEEG®’s prescription strategy for a large patient population with significant unmet needs. With many type 2 diabetes patients also suffering from renal impairment, offering a safe and effective treatment option is crucial. We remain steadfast in our mission to unlock Imeglimin’s full potential not only in Japan but also in other key Asian markets.”
Clinical Evidence Supporting Safety and Efficacy
The patent grant is supported by positive clinical data from the TWINKLE study, a post-marketing long-term trial conducted by Sumitomo Pharma in Japanese type 2 diabetes patients with renal impairment. Announced on August 7, 2024, the topline results confirmed TWYMEEG®’s favorable safety and tolerability profile, consistent with findings from earlier clinical studies in the general type 2 diabetes population.
These results have paved the way for Sumitomo Pharma to initiate discussions with Japanese regulatory authorities regarding the revision of the TWYMEEG® package insert. An outcome is expected in the first half of 2025, potentially enabling broader access to this life-changing therapy for patients with renal impairment.
Addressing a Growing Public Health Challenge
Diabetes and its associated complications, such as renal impairment, represent a major public health burden globally. In Japan alone, millions of individuals live with type 2 diabetes, many of whom face challenges managing their condition due to coexisting kidney dysfunction. Current treatment options often fall short in addressing the unique needs of these patients, making innovations like Imeglimin all the more vital.
Imeglimin’s mechanism of action sets it apart from traditional diabetes therapies. It targets mitochondrial bioenergetics, improving glucose metabolism through multiple pathways while maintaining a strong safety profile. This dual benefit makes it particularly suitable for patients with complex health conditions, such as those with both diabetes and renal impairment.
A Commitment to Innovation and Patient-Centric Solutions
Poxel’s focus on developing groundbreaking treatments for chronic diseases underscores its dedication to improving patient outcomes worldwide. By securing robust intellectual property protections, such as the newly granted patent in Japan, the company ensures that its innovations remain accessible to those who need them most. Furthermore, the alignment with Sumitomo Pharma highlights the power of strategic partnerships in advancing cutting-edge therapies.
As discussions with regulatory authorities progress, the potential inclusion of patients with eGFR levels below 45 mL/min/1.73m² in the TWYMEEG® prescribing information could mark a turning point in diabetes care. Such a development would provide healthcare providers with a much-needed tool to manage this high-risk patient group effectively.
Looking Ahead: Unlocking Imeglimin’s Potential
With the new patent in place and promising clinical data supporting its use, Imeglimin is poised to play a transformative role in the treatment of type 2 diabetes, particularly among patients with renal impairment. Beyond Japan, Poxel continues to explore opportunities to bring this innovative therapy to other markets, leveraging its strong patent portfolio and collaborative partnerships.
For patients living with type 2 diabetes and renal impairment, Imeglimin represents hope for better management of their condition. As Poxel advances its mission to address unmet medical needs, the company reaffirms its commitment to delivering safe, effective, and innovative treatments that improve lives.
In conclusion, the recent patent grant in Japan not only reinforces TWYMEEG®’s competitive edge but also underscores Poxel’s leadership in developing next-generation therapies for chronic metabolic diseases. With regulatory updates anticipated in early 2025, the future looks promising for Imeglimin as it moves closer to becoming a cornerstone treatment for diabetic patients with renal impairment across Asia and beyond.
