Introduction to Imeglimin
Imeglimin is a novel, first-in-class oral drug candidate developed by Poxel Pharma, targeting the mitochondrial respiratory chain to address type 2 diabetes. This innovative approach sets Imeglimin apart from existing treatments, making it a promising therapeutic option for managing this progressive disease.
Clinical Development and Trials
Phase 3 TIMES Program in Japan
Imeglimin has successfully completed the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program in Japan, conducted in partnership with Sumitomo Dainippon Pharma. The TIMES program, which includes the TIMES 1, TIMES 2, and TIMES 3 trials, demonstrated Imeglimin's efficacy in reducing HbA1c levels as a monotherapy and in combination with other standard treatments such as insulin, metformin, and DPP-4 inhibitors[4].
Regulatory Approval in Japan
Following the positive results from the Phase 3 trials, Sumitomo Dainippon Pharma submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in July 2020. This submission was supported by extensive preclinical and clinical data, including the TIMES trials[1][3].
Ongoing and Future Development
Poxel is preparing to advance Imeglimin into a Phase 3 development program in the US, Europe, and other countries not covered by the existing agreement with Sumitomo Dainippon Pharma. Despite Metavant not planning to continue the development of Imeglimin at this time, Poxel remains committed to its vision of developing innovative drugs for metabolic diseases and is exploring various options to move forward with Imeglimin[1].
Market Approval and Commercialization
Approval and Launch in Japan
Imeglimin, marketed as TWYMEEG® in Japan, received regulatory approval and was launched in 2021. The drug has shown significant commercial success, with gross sales in Japan increasing by 62% in the second quarter of 2024 compared to the first quarter, and a forecasted increase of 150% in gross sales for the full year 2024 compared to 2023[5].
Post-Marketing Studies
A post-marketing clinical study, TWINKLE, conducted by Sumitomo Pharma, confirmed the safety and tolerability profile of TWYMEEG® in Japanese type 2 diabetic patients with renal impairment. These results are expected to support discussions with regulatory authorities to revise the package insert and recommend TWYMEEG® for patients with renal impairment[5].
Mechanism of Action and Safety Profile
Unique Dual Mechanism
Imeglimin targets the mitochondrial respiratory chain, a unique mechanism of action that differentiates it from other anti-diabetic therapies. This dual mechanism allows Imeglimin to provide additive efficacy benefits when used in combination with other agents such as metformin, DPP-4 inhibitors, and insulin[3][4].
Safety and Tolerability
Clinical studies, including the Phase 3 TIMES trials and drug-drug interaction studies, have consistently shown that Imeglimin has a favorable safety and tolerability profile. It does not induce clinically relevant changes in the pharmacokinetic profiles of other important diabetes medications, making it a safe option for combination therapy[3][4].
Market Projection
Global Type 2 Diabetes Market
The global type 2 diabetes market is expected to see significant growth from 2019 to 2029, with sales projected to reach $136.2 billion by 2029, driven by a compound annual growth rate (CAGR) of 11.5%. Novel therapies, including GLP-1RAs like semaglutide and oral semaglutide, and SGLT-2 inhibitors like dapagliflozin, are expected to drive this growth[2].
Competitive Landscape
In the context of this growing market, Imeglimin's unique mechanism of action and favorable safety profile position it as a competitive option. While traditional branded therapies like sitagliptin are facing market decline due to patent expiries and generic competition, Imeglimin's potential to complement existing therapies and address multiple stages of type 2 diabetes makes it an attractive addition to the treatment armamentarium[2].
Revenue and Royalties
Poxel anticipates significant revenue from royalties on TWYMEEG® sales in Japan, with forecasted gross sales of JPY 11.3 billion (EUR 69.1 million) for FY 2024. The company is also in discussions to monetize these royalties, which will help sustain its operations and capital expenditure[5].
Key Takeaways
- Clinical Success: Imeglimin has successfully completed the Phase 3 TIMES program in Japan, demonstrating its efficacy and safety.
- Regulatory Approval: Approved in Japan and marketed as TWYMEEG®, with plans for further regulatory submissions in other regions.
- Unique Mechanism: Targets the mitochondrial respiratory chain, offering a novel approach to managing type 2 diabetes.
- Commercial Growth: Significant commercial success in Japan, with growing sales and potential for expansion into other markets.
- Market Potential: Positioned to benefit from the growing global type 2 diabetes market, driven by the need for innovative and effective therapies.
FAQs
What is Imeglimin and how does it work?
Imeglimin is a first-in-class oral drug candidate that targets the mitochondrial respiratory chain to address type 2 diabetes. It works by improving mitochondrial function, which is crucial for cellular energy production.
What are the key findings from the Phase 3 TIMES trials?
The Phase 3 TIMES trials demonstrated Imeglimin's efficacy in reducing HbA1c levels as a monotherapy and in combination with other standard treatments. The trials also highlighted its favorable safety and tolerability profile.
Is Imeglimin approved for use in any countries?
Yes, Imeglimin, marketed as TWYMEEG®, is approved and launched in Japan. Regulatory submissions are being prepared for other regions, including the US and Europe.
How does Imeglimin compare to other type 2 diabetes treatments?
Imeglimin's unique mechanism of action and favorable safety profile make it a competitive option. It can be used in combination with other therapies, providing additive efficacy benefits without significant drug-drug interactions.
What are the market projections for Imeglimin?
Imeglimin is expected to benefit from the growing global type 2 diabetes market. With forecasted significant sales in Japan and potential expansion into other markets, Imeglimin is poised to become a key player in the treatment of type 2 diabetes.
What is the current commercial performance of TWYMEEG® in Japan?
TWYMEEG® has shown significant commercial success in Japan, with a 62% increase in gross sales in the second quarter of 2024 compared to the first quarter, and a forecasted 150% increase in gross sales for the full year 2024 compared to 2023.
Sources
- Poxel Provides Update on Metavant Partnership with Imeglimin - Poxel Pharma
- T2D market growth driven by novel GLP-1RAs and once-weekly ... - Pharmaceutical Technology
- Poxel Announces Publication of Imeglimin Clinical Study Results in ... - Poxel Pharma
- Poxel and Sumitomo Dainippon Pharma Announce Positive Topline Phase 3 Results from TIMES 2 Trial of Imeglimin for the Treatment of Type 2 Diabetes in Japan and Successful Completion of the Pivotal TIMES Clinical Development Program - Sumitomo Pharma
- Poxel Reports Revenue for the Second Quarter and First Half 2024 - Poxel Pharma