With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin
Eli Lilly announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials for their once-weekly insulin efsitora alfa. The trials demonstrated that efsitora alfa provides non-inferior A1C reduction compared to daily insulin therapies, with similar safety and efficacy profiles. In QWINT-2, insulin-naïve adults using efsitora saw a 1.34% reduction in A1C over 52 weeks, comparable to insulin degludec's 1.26%. QWINT-4 showed a 1.07% A1C reduction in adults already on basal insulin, equivalent to insulin glargine. Both trials showed efsitora was well-tolerated, with hypoglycemia rates comparable to daily insulins. Detailed QWINT-2 results will be presented at the EASD Annual Meeting 2024, with further trial results expected later this year.
- Efsitora alfa demonstrated non-inferior A1C reduction compared to daily insulin therapies.
- QWINT-2 showed a 1.34% A1C reduction with efsitora, slightly higher than insulin degludec's 1.26%.
- QWINT-4 reported a 1.07% A1C reduction with efsitora, comparable to insulin glargine's 1.07%.
- Patients on efsitora spent 45 more minutes in range and 37 more minutes in tight range without additional hypoglycemia compared to insulin degludec.
- Efsitora was found to be safe and well-tolerated in both trials.
- Higher rates of hypoglycemic events were observed with efsitora: 0.58 events per patient-year in QWINT-2 versus 0.45 with insulin degludec.
- In QWINT-4, efsitora showed 6.6 events per patient-year compared to 5.9 with insulin glargine.
Insights
Efsitora alfa represents a noteworthy advancement in diabetes care. The Phase 3 trials QWINT-2 and QWINT-4 established that once-weekly dosing achieves comparable A1C reductions to daily basal insulins like insulin degludec and insulin glargine. From a clinical perspective, this is significant because it simplifies the treatment regimen, potentially enhancing patient adherence and compliance. When patients need fewer injections, they are more likely to stay consistent with their therapy, which can lead to better overall health outcomes.
The A1C reduction of
These findings are crucial, especially for insulin-naive patients and those requiring multiple injections daily. A shift to once-weekly dosing could reduce patient fatigue and anxiety associated with frequent injections.
Eli Lilly's announcement is economically significant. The positive results from the QWINT-2 and QWINT-4 trials could potentially open a large market segment for once-weekly insulin. The demand for innovative diabetes treatments is high and a product that offers similar efficacy with fewer doses can disrupt the market dynamics.
Investors should consider the market potential of efsitora. As diabetes incidence rises globally, a more convenient treatment option is highly attractive. If Eli Lilly successfully brings efsitora to market, it could capture a significant share of the basal insulin market, challenging established products like insulin degludec and glargine.
The financial impact will hinge on the product’s pricing strategy, patient uptake and insurance coverage. However, given the positive clinical data, Eli Lilly is positioned well to leverage this development into a strong revenue stream. This aligns with the company's broader strategy of innovative treatment solutions and could enhance its competitive edge in the pharmaceutical industry.
The introduction of efsitora alfa could have meaningful market implications. The global insulin market is competitive, but a once-weekly product offers a unique value proposition. By reducing the frequency of injections, efsitora addresses pain points experienced by many diabetes patients, making it a compelling option.
From a market research perspective, it’s essential to monitor patient and physician acceptance. The trials have shown that efsitora is effective and safe, but real-world data will be important to assessing its long-term success. Marketing efforts will need to focus on educating both groups about the benefits of reduced injection frequency and ensuring that any perceived barriers to switching from daily to weekly injections are addressed.
Additionally, competitor responses will be worth watching. Companies like Novo Nordisk and Sanofi, which produce leading basal insulins, may need to innovate or adjust their strategies to maintain market share. Overall, efsitora's potential to improve adherence and provide ease of use positions it well for market entry.
Efsitora met the primary endpoint in both QWINT-2 and QWINT-4 with once-a-week dosing regimen for people living with type 2 diabetes
Efsitora was equally safe and effective among adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists
"The results of QWINT-2 and QWINT-4 are a significant milestone for the diabetes community and demonstrate that efsitora as a weekly insulin provides blood sugar control equivalent to daily basal insulins," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes."
QWINT-2 evaluated the efficacy and safety of once-weekly efsitora compared to once-daily insulin degludec for 52 weeks. The trial randomized insulin-naïve adults with type 2 diabetes to receive efsitora once weekly or insulin degludec once daily and was also designed to assess efficacy in patients using and not using GLP-1 receptor agonists.
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 52. For the efficacy estimand1,2, efsitora reduced A1C by
QWINT-4 evaluated the efficacy and safety of efsitora compared to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized participants to receive efsitora once weekly or insulin glargine once daily, both of which were administered with insulin lispro.
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 26. For the efficacy estimand, both efsitora and insulin glargine reduced A1C by
In both QWINT-2 and QWINT-4, efsitora was safe and well-tolerated with estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec (QWINT-2) and 6.6 with efsitora vs. 5.9 with insulin glargine (QWINT-4).
Detailed results from QWINT-2 will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024. Topline readouts from QWINT-1, QWINT-3 and QWINT-5 are anticipated later this year.
About the QWINT clinical trial program
The QWINT phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 4,000 people living with type 1 or type 2 diabetes across five global registration studies.
QWINT-2 (NCT05362058) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 928 participants across the
QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the
About insulin efsitora alfa
Insulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase 3 development for adults with type 1 and 2 diabetes.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 The efficacy estimand represents the treatment effect had all participants adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia.
2
3 From a baseline A1C of
4 Blood glucose 70-180 mg/dL.
5 Blood glucose 70-140 mg/dL.
6 From a baseline A1C of
7
Refer to: | Niki Smithers; smithers_niki@lilly.com, 317-358-9074 (Media) |
Joe Fletcher; jfletcher@lilly.com, 317-296-2884 (Investors) |
View original content to download multimedia:https://www.prnewswire.com/news-releases/with-once-a-week-dosing-insulin-efsitora-alfa-delivers-a1c-reduction-and-safety-profile-consistent-with-daily-insulin-302147034.html
SOURCE Eli Lilly and Company
FAQ
What were the results of Eli Lilly's QWINT-2 trial for insulin efsitora alfa?
How did insulin efsitora alfa perform in the QWINT-4 trial?
What is the primary endpoint of the QWINT-2 trial for insulin efsitora alfa?
What is the safety profile of insulin efsitora alfa according to the QWINT-2 and QWINT-4 trials?
When will the detailed results of the QWINT-2 trial be presented?
