In the phase 3 study, QWINT-1, efsitora was
administered via four fixed doses once weekly in a single-use
autoinjector in people with type 2 diabetes using basal insulin for
the first time
In a second phase 3 study, QWINT-3, efsitora
also delivered non-inferior A1C reduction compared to daily insulin
in people with type 2 diabetes switching from daily basal
injections
INDIANAPOLIS, Sept. 5,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) today announced positive topline results from the QWINT-1 and
QWINT-3 phase 3 clinical trials evaluating once weekly insulin
efsitora alfa (efsitora) in adults with type 2 diabetes using basal
insulin for the first time (insulin naïve) and in those who have
switched from daily basal insulin injections, respectively. In
these long-term treat-to-target trials, efsitora showed
non-inferior A1C reduction compared to the most frequently used
daily basal insulins globally.
"Once weekly insulins, like efsitora, have the potential to
transform diabetes care as we know it," said Jeff Emmick, M.D., Ph.D., senior vice president,
product development, Lilly. "Many patients are reluctant to start
insulin because of the burden it places on them. With a simple
fixed-dose regimen, once-weekly efsitora could make it easier for
people with diabetes to start and manage insulin therapy, while
reducing the impact it has on their day-to-day lives."
QWINT-1 evaluated the efficacy and safety of once weekly
efsitora compared to once daily insulin glargine for 52 weeks. The
trial randomized adults with type 2 diabetes who are insulin naïve
to receive either efsitora once weekly in a single-use autoinjector
or insulin glargine once daily. Efsitora was titrated across four
fixed doses1 at four-week intervals, as needed for blood
glucose control. The study's goal was to provide data supporting
real-life applications of fixed dose regimens, which have the
potential to make it easier for people living with diabetes to
start and manage insulin therapy.
The trial met its primary endpoint of non-inferior A1C reduction
with efsitora compared to insulin glargine at week 52. For the
efficacy estimand2,3, efsitora reduced A1C by 1.31%
compared to 1.27% for insulin glargine, resulting in an A1C of
6.92% and 6.96%, respectively4. For the
treatment-regimen estimand5,6, efsitora reduced A1C
by 1.19% compared to 1.16% for insulin glargine, resulting in an
A1C of 7.05% and 7.08%, respectively4.
QWINT-3 evaluated the efficacy and safety of once weekly
efsitora compared to once daily insulin degludec for 78 weeks in
adults with type 2 diabetes currently treated with basal insulin.
Participants were randomized 2:1 to receive either efsitora once
weekly or insulin degludec once daily.
The QWINT-3 trial met its primary endpoint of non-inferior A1C
reduction with efsitora compared to insulin degludec at week 26.
For the efficacy estimand7, efsitora reduced A1C by
0.86% compared to 0.75% for insulin degludec resulting in an A1C of
6.93% and 7.03%, respectively8. For the
treatment-regimen estimand9, efsitora reduced
A1C by 0.81% compared to 0.72% for insulin degludec resulting in an
A1C of 6.99% and 7.08%, respectively10.
Additionally, participants taking efsitora or insulin degludec
spent approximately two hours more time in range (glucose
70-180 mg/dL) per day for weeks 22-26 compared to baseline. For the
efficacy estimand11, participants taking efsitora
spent 62.8% of time in range compared to 61.3% for insulin degludec
for weeks 22-2612. For the
treatment-regimen estimand13, participants
taking efsitora spent 61.4% of time in range compared to 61%
for insulin degludec14. Further, for the
efficacy estimand, participants taking efsitora spent 38.3% of
time in tight range (glucose 70-140 mg/dL) compared to 36.8% for
insulin degludec for weeks 22-2615.
In both QWINT-1 and QWINT-3, the overall safety and tolerability
profile of efsitora was similar to that of daily basal insulin
therapies for the treatment of type 2 diabetes. In QWINT-1,
estimated combined rates of severe or clinically significant (blood
glucose <54 mg/dL) hypoglycemic events per patient-year of
exposure from weeks 0-52 were 0.50 with efsitora vs. 0.88 with
insulin glargine – approximately 40% lower with efsitora than
insulin glargine. In QWINT-3, estimated combined rates of severe or
clinically significant (blood glucose <54
mg/dL) hypoglycemic events per patient-year of exposure from
weeks 0-78 were 0.84 with efsitora vs. 0.74 with insulin
degludec.
Detailed results for QWINT-1 and QWINT-3 will be shared at an
upcoming congress and published in a peer-reviewed journal.
Additionally, detailed results for QWINT-2 and QWINT-5 will be
presented at the European Association for the Study of Diabetes
(EASD) Annual Meeting 2024.
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-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 to insulin glargine for 52 weeks in
insulin-naïve adults with type 2 diabetes. The trial randomized 796
participants across the U.S., Argentina, Mexico and Puerto
Rico to receive efsitora once weekly or insulin glargine
once daily administered subcutaneously. All participants treated
with efsitora received a starting dose of 100 units followed by a
fixed dose escalation to achieve a target fasting blood glucose of
80-130 mg/dL. Fasting blood glucose was measured every four weeks
and participants escalated to fixed dosages of 150 units, 250 units
and 400 units as appropriate. 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 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 period, and 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.
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), including statements 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 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.
2 The efficacy estimand represents the treatment effect
had all participants adhered to the study drug without initiating
rescue therapy for persistent severe hyperglycemia.
3 95% CI for treatment difference (-0.19% to 0.12%).
4 From a baseline A1C of 8.20% for efsitora
and 8.28% for insulin glargine.
5 Treatment-regimen estimand represents the efficacy
irrespective of adherence to the investigational medicine or
introduction of rescue therapy for persistent severe
hyperglycemia.
6 95% CI for treatment difference (-0.18% to 0.12%).
7 95% CI for treatment difference (-0.22% to 0%).
8 From a baseline A1C of 7.80% for efsitora and insulin
degludec.
9 95% CI for treatment difference (-0.191% to
0.013%).
10 From a baseline A1C of 7.80% for efsitora and 7.79%
for insulin degludec.
11 95% CI for treatment difference (-0.94 to 3.84).
12 From a baseline time in range of 51.95% for efsitora
and 52.66% for insulin degludec.
13 95% CI for treatment difference (-1.88 to 2.72).
14 From a baseline time in range of 52.10% for efsitora
and 52.43% for insulin degludec.
15 From a baseline tight time in range of 26.3% for
efsitora and 27.1% for insulin degludec.
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