American Diabetes Association Symposium Shows
Patients with Type 1 Diabetes Experienced Insulin Independence and
Elimination of Severe Hypoglycemic Events with Novel
Therapy
ORLANDO,
Fla., June 21, 2024 /PRNewswire/ -- Today, new
data from the Phase 1/2 FORWARD clinical study of the VX-880 islet
cell therapy was presented at a symposium at the American Diabetes
Association® (ADA) 84th Scientific Sessions in Orlando, FL. The results demonstrated that
VX-880 reduced or eliminated the need for insulin use in patients
with type 1 diabetes (T1D), indicating that VX-880 stem
cell-derived islets can restore physiological islet function
and glycemic control.
Despite use of advanced diabetes technologies, a recent survey
of individuals with type 1 diabetes revealed that approximately 6%
of people experience recurrent severe hypoglycemic events and have
impaired awareness of hypoglycemia. Hypoglycemia, known as low
blood glucose, is common in individuals with type 1 diabetes.
People with type 1 diabetes may develop impaired awareness of
hypoglycemia over time, meaning they may not feel symptoms despite
blood glucose readings falling below a level that may provoke
symptoms. If left untreated, this can lead to severe hypoglycemic
events (SHEs) which can present as confusion, coma, seizures,
cardiovascular events, and even death. Currently, there are limited
treatment options beyond exogenous insulin for the management of
the disease, creating a substantial unmet medical need for those
living with type 1 diabetes.
The phase 1/2, open-label three-part study enrolled adults with
type 1 diabetes, impaired hypoglycemic awareness, and at least two
SHEs in the year before screening. The study evaluated the use of
VX-880, an investigational, allogeneic, stem cell-derived, fully
differentiated insulin-producing islet cell therapy. Participants
had an average age of approximately 44 years, mean HbA1c 7.8%,
total daily insulin use of approximately 40 units per day, and had
experienced between two and four SHEs in the year prior to
screening, and all participants had undetectable C peptide at
baseline - a sign that your body is producing insulin.
Participants who received a full dose of VX-880 as a single
infusion demonstrated engraftment of islet cells and endogenous
insulin (C-peptide) production, eliminated severe hypoglycemic
events, and significantly improved glycemic control while
simultaneously reducing or eliminating insulin use. All 12
participants achieved a reduction in HbA1c to <7.0% and a time
in target range of >70%.
Of 10 participants who completed the Day 180
visit: seven are no longer using
exogenous insulin and two had approximately 70%
reduction in their daily insulin use. Notably, 100% of patients
with greater than one year of follow-up met the criteria for the
primary endpoint of eliminating SHEs with HbA1c <7.0% at month
12 and achieved the secondary endpoint of insulin independence.
These data indicate that VX-880 stem cell-derived islets function
like bona fide islets and have the potential to provide profound
benefit to patients.
"This positive data adds to the growing body of evidence
for VX-880's potential to revolutionize the treatment of type 1
diabetes that would give patients an alternative solution other
than exogenously administered insulin," said Piotr Witkowski, MD, PhD, Professor of Surgery,
Director, Pancreatic and Islet Transplant Program, University of Chicago, Chicago, IL, and one of the investigators
conducting the study. "These findings will also support further
evaluation of VX-880, and we hope to see this treatment become a
pivotal development in type 1 diabetes care."
The trial has been further expanded to enroll a total of
approximately 37 participants in order to generate clinical data
that will support the goal of making VX-880 available for people
living with type 1 diabetes in the future.
Research presentation details:
Professor Witkowski
will present the findings at the following symposium:
- Symposium - Joint ADA/IPITA Symposium
Clinical Beta-Cell Replacement Therapy Today
- Presented on Friday, June 21,
2024 at 3:45 PM EDT
About the ADA's Scientific Sessions
The ADA's 84th
Scientific Sessions, the world's largest scientific meeting focused
on diabetes research, prevention, and care, will be held in
Orlando, FL on June 21-24. More than 11,000 leading physicians,
scientists, and health care professionals from around the world are
expected to convene both in person and virtually to unveil
cutting-edge research, treatment recommendations, and advances
toward a cure for diabetes. Attendees will receive exclusive access
to thousands of original research presentations and take part in
provocative and engaging exchanges with leading diabetes experts.
Join the Scientific Sessions conversation on social media using
#ADAScientificSessions.
About the American Diabetes Association
The American
Diabetes Association (ADA) is the nation's leading voluntary health
organization fighting to bend the curve on the diabetes epidemic
and help people living with diabetes thrive. For 83 years, the ADA
has driven discovery and research to treat, manage, and prevent
diabetes while working relentlessly for a cure. Through advocacy,
program development, and education we aim to improve the quality of
life for the over 136 million Americans living with diabetes or
prediabetes. Diabetes has brought us together. What we do next will
make us Connected for Life®. To learn more or to get involved,
visit us at diabetes.org or call 1-800-DIABETES
(1-800-342-2383). Join the fight with us on Facebook (American
Diabetes Association), Spanish Facebook (Asociación Americana de la
Diabetes), LinkedIn (American Diabetes Association), Twitter
(@AmDiabetesAssn), and Instagram (@AmDiabetesAssn).
Media contact
Amy
Robinson
arobinson@brgcommunications.com
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SOURCE American Diabetes Association