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
INDIANAPOLIS, May 16, 2024
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced
positive topline results from the QWINT-2 and QWINT-4 phase 3
clinical trials evaluating once-weekly insulin efsitora alfa
(efsitora) in adults with type 2 diabetes using insulin for the
first time (insulin naïve) and those who require multiple daily
insulin injections. In the treat-to-target clinical trials,
efsitora showed non-inferior A1C reduction compared to the most
commonly used daily basal insulins globally.
"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 1.34%
compared to 1.26% for insulin degludec resulting in an A1C of 6.87%
and 6.95% respectively3. In a key secondary endpoint,
efsitora was non-inferior to insulin degludec in A1C change among
participants using and not using GLP-1 receptor agonists. Further,
participants taking efsitora spent 45 minutes more time in
range4 and 37 minutes more in tight
range5 without additional time in hypoglycemia
(blood glucose <54 mg/dL) in comparison to insulin
degludec.
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 1.07% resulting in an A1C of 7.12% and 7.11%,
respectively6,7.
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 U.S.,
Brazil, Canada, China, Czechia (Czech Republic), Germany, Greece, Japan, Korea, Mexico and Puerto
Rico to receive efsitora once weekly or insulin degludec
once daily administered subcutaneously. The primary objective of
the trial was to demonstrate non-inferiority in reducing A1C at
week 52 with efsitora compared to insulin degludec. The trial was
also designed to assess efficacy and safety for patients using and
not using GLP-1 receptor agonists.
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.
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 95% CI for treatment difference (-0.22% to
0.061%).
3 From a baseline A1C of 8.21% for efsitora
and 8.23% for insulin degludec.
4 Blood glucose 70-180 mg/dL.
5 Blood glucose 70-140 mg/dL.
6 From a baseline A1C of 8.18% for efsitora
and insulin glargine.
7 95% CI for treatment difference (-0.13% to
0.14%).
Refer
to:
|
Niki Smithers;
smithers_niki@lilly.com, 317-358-9074 (Media)
|
|
Joe Fletcher;
jfletcher@lilly.com, 317-296-2884 (Investors)
|
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SOURCE Eli Lilly and Company