Latest news with #Efsitora
Yahoo
10-07-2025
- Business
- Yahoo
Eli Lilly (LLY) Announced Results for its Once-Weekly Insulin
Eli Lilly and Company (NYSE:LLY) is one of the 10 Best Non-Tech Stocks to Buy and Hold For 3 Years. On June 22, Eli Lilly and Company (NYSE:LLY) announced new results for its once-weekly insulin, Efsitora alfa. The drug is being tested for adults with type 2 diabetes. The company released results for QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials. Each trial looked at a different group of patients. QWINT-1 looked at people starting insulin for the first time, QWINT-3 looked at people already using insulin daily, and QWINT-4 tested people who used both daily basal and mealtime insulin. The main goal was to see if Efsitora could lower A1C as well as daily insulin. Results showed that Eli Lilly and Company (NYSE:LLY)'s Efsitora lowered A1C by 1.31% for QWINT-1, 0.58% for QWINT-3, and 1.07% after 26 weeks for QWINT-4. The treatment is notable as Efsitora only needs to be injected once a week. Eli Lilly and Company (NYSE:LLY) is a pharmaceutical company that focuses on diabetes, oncology, immunology, neuroscience, and other therapeutic areas. While we acknowledge the potential of LLY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Web Release
05-07-2025
- Health
- Web Release
Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials
Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.3 In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.4 In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.5 In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. 'The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes,' said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator for QWINT-1. 'A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins.' QWINT-1 Primary Endpoint QWINT-3 Primary and Key Secondary Endpoints QWINT-4 Primary and Key Secondary Endpoints Efficacy Estimand Treatment-Regimen Estimand6 Primary Endpoint – A1C Reduction (Resulting A1C) at Week 52 Efsitora -1.31% (6.92%) -1.19% (7.05%) Glargine -1.27% (6.96%) -1.16% (7.08%) Efficacy Estimand Treatment-Regimen Estimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -0.86% (6.93%) -0.81% (6.99%) Degludec -0.75% (7.03%) -0.72% (7.08%) Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal Hypoglycemic Events Per Patient-Year of Exposure up to Week 787,8 Efsitora 0.11 Degludec 0.10 Key Secondary Endpoint – Percent Time in Range (70-180 mg/dL) During the 4 Weeks Prior to Week 26 Efsitora 62.8% 61.4% Degludec 61.3% 61.0% Efficacy Estimand Treatment-Regimen Estimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -1.07% (7.12%) -1.01% (7.17%) Glargine -1.07% (7.11%) -1.00% (7.18%) Key Secondary Endpoint – Participants Achieving A1C <7% at Week 26 Without Nocturnal Hypoglycemia Efsitora 39.5% 38.6% Glargine 36.6% 35.9% Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal Hypoglycemic Events Per Patient-Year of Exposure up to Week 26 Efsitora 0.67 Glargine 1.00 'Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year,' said Jeff Emmick, MD, Ph.D., senior vice president of product development at Lilly. 'These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world.' Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, efsitora resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks. In QWINT-3, these rates were 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, rates of estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks. Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of 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 3,000 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) 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 using a fixed dose escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every 4 weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. 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 U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. 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. 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 tens of millions of 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 and or follow us on Facebook, Instagram, and LinkedIn. P-LLY 1. The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. 2. From a baseline of 8.20% for efsitora and 8.28% for insulin glargine. 3. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every 4 weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. 4. From a baseline of 7.80% for both efsitora and insulin degludec. 5. From a baseline of 8.18% for both efsitora and insulin glargine. 6. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia. 7. Blood glucose <54 mg/dL. 8. Nocturnal hypoglycemia was defined as any event that occurred at night between midnight and 6 a.m. 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 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. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Time of India
26-06-2025
- Health
- Time of India
Inhaled insulin as good as injection for children at mealtime
London: Children with diabetes who inhaled their mealtime doses of insulin did just as well as those who injected insulin under the skin, researchers reported at the American Diabetes Association scientific meeting in Chicago. To regulate their blood sugar, patients with type 1 diabetes usually require an injection of a long-acting basal insulin once a day, plus additional injections of rapid-acting insulins at mealtimes. MannKind's inhaled insulin Afrezza is approved for use by adults but not yet for children, which prompted the study. The 230 children with type 1 diabetes, ages 4 to 17, who participated in the trial received either Afrezza at mealtimes, or their usual mealtime injections of insulin, for 26 weeks. Everyone continued to receive their basal insulin injections. Control of hemoglobin A1c, a marker of blood sugar control over the past several months, was comparable with the inhaled insulin and the injected insulin, the researchers found. Inhaled insulin was also associated with less weight gain and slightly higher child and parent preference scores. The inhaled formula did not have any adverse effects on patients' lungs, the researchers reported. "Inhaled insulin is the fastest acting insulin available and is a valuable alternative to injected analogue insulin," study leader Dr. Michael Haller of the University of Florida said in a statement. "Afrezza should be available as an option to all children and adults with type 1 diabetes." ONCE-WEEKLY INSULIN PROMISING FOR TYPE 2 DIABETES Eli Lilly's experimental once-weekly insulin efsitora was comparable to daily insulins in nearly a thousand adults with type 2 diabetes in three late-stage trials, researchers reported at the ADA meeting. The trials, which were designed to study patients at different stages of insulin use, each found efsitora to be just as effective as daily insulins for bringing HbA1c levels - a common measure of blood sugar over time - under control. "Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Lilly's senior vice president of product development, Jeff Emmick, said in a statement. One trial, reported in The New England Journal of Medicine, involved patients with type 2 diabetes who were using insulin for the first time. A second trial in patients who had been using daily basal insulin degludec and a third trial in those who had been taking basal insulin glargine plus extra mealtime insulin doses were both reported in The Lancet. Efsitora "has the potential to facilitate and simplify insulin therapy , reducing the hesitation often associated with starting insulin to treat type 2 diabetes," Dr. Julio Rosenstock of University of Texas Southwestern Medical Center, who led one of the studies, said in a statement. People newly diagnosed with type 2 diabetes usually start treatment with oral medications, but roughly one-third of them will need to use insulin within 8 years of their diagnosis, according to an editorial in The Lancet. GENETICALLY ENGINEERED SKIN GRAFTS TREAT BLISTERING DISEASE Long-lasting wounds from a painful genetic skin disease can be healed with skin grafts genetically engineered from a patient's own cells, researchers reported in The Lancet. In severe dystrophic epidermolysis bullosa , or EB, the skin is so fragile the slightest touch - even from clothing - causes blistering and wounds, eventually leading to large, open lesions that never heal. "With our novel gene therapy technique, we successfully treated the hardest-to-heal wounds, which were usually also the most painful ones for these patients," study leader Dr. Jean Tang of Lucile Packard Children's Hospital Stanford in Palo Alto, California said in a statement. Severe dystrophic EB is caused by a defect in the gene for collagen VII, a protein that normally holds the skin together. As a result, the layers of the skin separate in response to even slight friction. To create the personalized skin grafts, doctors take a small biopsy sample of the patient's un-wounded skin and introduce a corrected version of the collagen VII gene to the skin cells. These cells are then grown into sheets of healthy skin. For the late-stage study, 11 patients with recessive dystrophic EB had a total of 43 wounds treated with grafts. For each treated wound, the researchers also identified a comparable "control" wound on the same patient that was managed with traditional measures. Six months later, 81% of treated wounds were at least half healed, compared with 16% of control wounds. Roughly two-thirds of treated wounds were at least three-quarters healed, compared with 7% of control wounds, and 16% of treated wounds had completely healed, compared with none of the control wounds. In addition, grafted areas had less pain, itching and blistering. The same research team had previously developed a gene therapy gel for treating smaller EB wounds. "I hope that if these patients are diagnosed as infants and start the gene therapy gel, maybe they won't develop big wounds," Tang said. "But if the gels don't work and a wound does expand, the skin graft therapy is the right treatment. The life arc of their disease will, I hope, be modified, with less suffering." An editorial published with the study notes that EB patients who participated in early-stage trials of the skin grafts still had decreased blistering and wounding, pain, and itch at grafted sites five years later. In April, the U.S. Food and Drug Administration granted Abeona Therapeutics approval for the skin grafts as an EB therapy. (To receive the full newsletter in your inbox for free sign up here)
