Press Release: TZIELD® Phase 3 data presented at ISPAD shows
potential to slow the progression of Stage 3 type 1 diabetes in
newly diagnosed children and adolescents; full data simultaneously
published in The NEJM
TZIELD® Phase 3 data presented at ISPAD shows
potential to slow the progression of Stage 3 type 1 diabetes in
newly diagnosed children and adolescents; full data simultaneously
published in The New England Journal of Medicine
- TZIELD met the study’s primary
endpoint, significantly slowing the decline of C-peptide levels,
compared to placebo
- Numerical trends favoring TZIELD
were seen in key secondary endpoints, whilst statistical
significance was not achieved
- PROTECT builds on the existing body
of evidence on TZIELD’s potential to slow the progression of type 1
diabetes
- TZIELD fits at the intersection of
Sanofi’s growth in immune-mediated diseases and disease modifying
therapies, and the company’s expertise in diabetes
Paris, October 18, 2023. New
data from TZIELD’s (teplizumab-mzwv) PROTECT Phase 3 trial were
presented today at the 49th Annual ISPAD Conference, in Rotterdam,
The Netherlands. PROTECT studied the efficacy and safety of TZIELD,
compared to placebo, to slow the loss of beta cells and preserve
beta cell function as measured by C-peptide, in children and
adolescents aged 8-17 years diagnosed in the preceding 6 weeks with
Stage 3 autoimmune type 1 diabetes (T1D). The full data set has
been simultaneously published in The New England Journal of
Medicine.
TZIELD met the study’s primary endpoint,
demonstrating superior beta cell preservation assessed by
significantly slowing the decrease in mean C-peptide levels (area
under the curve [AUC] after a 4-hour mixed meal tolerance test) at
trial completion, compared to placebo. C-peptide is a biomarker for
beta cell function. This significant difference indicates the
potential of TZIELD to slow the progression of Stage 3 type 1
diabetes in this population. While the study’s key secondary
endpoints did not meet statistical significance, numerical trends
favoring TZIELD were seen in relevant clinical parameters. On
average, people on TZIELD required numerically fewer insulin units
and had numerically higher time in range, compared to those on
placebo. HbA1c reductions and the overall rates of clinically
important low blood sugar (hypoglycemic) events were similar among
both study groups.
Kevan Herold, MDC.N.H. Long
Professor of Immunobiology and of Medicine (Endocrinology), Yale
School of Medicine and Primary Investigator of PROTECT.“Type 1
diabetes is a chronic autoimmune disease, driven by the destruction
of the insulin-producing beta cells, and as such, beta cell
preservation remains a meaningful unmet need for all patients with
diabetes. These new results build on the findings from multiple
studies across different stages of the disease process, further
supporting TZIELD’s potential to modulate the progression of
T1D.”
Jose Eduardo Neves, M.D.Senior
Vice President, Global Head of Medical Affairs, General Medicines,
Sanofi“The PROTECT results are encouraging, as we believe they
showcase the potential for TZIELD to slow down the progression of
Stage 3 T1D in this population, as well as pointing towards
favorable trends in relevant aspects for clinicians and people
living with type 1 diabetes. We look forward to discussing this new
data with the scientific community and regulatory authorities
around the world.”
The availability of the PROTECT data represents
a key early milestone for Sanofi on TZIELD, following the
acquisition of Provention Bio (a Sanofi Company) in April 2023.
TZIELD is a strategic fit for Sanofi at the intersection of our
growth in immune-mediated diseases and disease modifying therapies,
and our company’s expertise in diabetes.
Key ResultsThe PROTECT clinical trial was a
randomized, double blind, placebo-controlled, multi-national trial.
From baseline and through the trial’s completion at 78 weeks, the
following was observed for TZIELD vs placebo:
Primary endpoint
-
Significantly less decrease in mean C-peptide levels (area
under the concentration curve [AUC], following a 4-hour mixed-meal
tolerance test [MMTT]): difference in least-squares means
(LSM) of 0.13 pmol/mL; (95% CI: 0.09, 0.17; P<0.001).
- 94.9% of
participants in the TZIELD group maintained peak C-peptide levels
≥0.2 pmol/mL, compared with 79.2% of those who received the placebo
(P<0.001).
Secondary endpoints
-
Numerically lower mean insulin dose in favor of TZIELD at
Week 78: the least-square mean (LSM) for insulin dose at
week 78 was 0.46 U/Kg/day (TZIELD) and 0.59 U/kg/day (placebo),
difference -0.13 U/kg/day (95% CI: -0.28, 0.02).
-
Comparable change in mean HbA1c: LSM change of
-1.98% (TZIELD) vs -1.89% (placebo), difference -0.09 (95% CI:
-0.42, 0.24)
-
Numerically higher mean time in range at week 78 in favor
of TZIELD (>70 but ≤180 mg/dL): 68.7±19.6% (TZIELD) vs
64.6±22.4% (placebo). Difference of 4.71% (95% CI: -1.72,
11.15).
- Similar
mean rates of overall clinically important hypoglycemic
events: estimated rates of 4.68 (TZIELD) (95% CI: 3.70,
5.91) vs 4.24 (placebo) (95% CI: 3.06, 5.89) events/patient-year,
with an estimated rate ratio of 1.10 (95% CI: 0.74, 1.64).
The safety results of the trial were consistent
with previous data from TZIELD’s currently approved FDA indication
to delay the onset of Stage 3 type 1 diabetes in adults and
children 8 years and older diagnosed with Stage 2 T1D, as well as
other prior clinical studies with TZIELD. No new safety signals
were identified.
Adverse events of special interest (AESI) were
prespecified and occurred in 29% of those on TZIELD vs 21.6% on
placebo, the most frequent one being hypoglycemia (TZIELD: 13.4%;
placebo: 16.2%). Other common adverse events (AEs) were headache,
nausea, rash, lymphopenia and vomiting. Serious adverse events
(SAEs) were reported by 5.5% of participant who received TZIELD vs
5.4% on placebo; the most common SAEs were cytokine release
syndrome (TZIELD: 1.4%; placebo 0%) and infections (TZIELD: 0%;
placebo: 2.7%).
The use of TZIELD in the PROTECT population is
investigational, and its safety and efficacy in this population has
not been evaluated by any regulatory authority.
About PROTECTPROTECT (NCT03875729) is a Phase 3,
randomized, double blind, placebo-controlled, multi-national
clinical trial. It enrolled 328 children and adolescents (TZIELD
n=217, placebo n=111) aged 8-17 years diagnosed with clinical,
Stage 3 T1D in the preceding 6 weeks; randomization ratio of
TZIELD:placebo was 2:1. Participants received a first course of 12
daily infusions (of either TZIELD or placebo) at randomization,
followed by a second course of 12 daily infusions after 26 weeks
(approx. 6 months). All participants received standard-of-care as
required.
The primary objective of PROTECT was to determine whether TZIELD
can slow down beta cell loss and preserve beta cell function
measured by C-peptide, compared to placebo. This was assessed via
the trial’s primary endpoint, which measured the difference in mean
change of C-peptide level (area under the time-concentration curve
[AUC] measured after a 4-hour mixed meal tolerance test) from
baseline to Week 78 between both groups.
Key secondary endpoints included HbA1c, time in range (TiR) as
measured with a CGM, clinically important low blood sugar
(hypoglycemia) events and exogenous insulin use. Time in range was
defined as: >70 but ≤180 mg/d. Clinically relevant hypoglycemic
events were defined: level 2 hypoglycemia (<54 mg/dL / 3.0
mmol/L) and level 3 hypoglycemia as episodes of severe cognitive
impairment requiring external assistance for recovery, even in the
absence of a blood glucose reading.
Other secondary endpoints were adverse events and overall safety
aspects, as well as pharmacokinetics (PK) and immunogenicity of
TZIELD. An observational extension study following participants for
a further 42 months is ongoing.
About TZIELDTZIELD (teplizumab-mzwv) is a
CD3-directed monoclonal antibody. TZIELD is the first and only
disease modifying therapy in autoimmune type 1 diabetes (T1D); it
was approved by the U.S. FDA in November 2022 to delay the onset of
Stage 3 type 1 diabetes in adults and children 8 years and older
diagnosed with Stage 2 T1D.
About autoimmune, type 1 diabetes (T1D)T1D is a
chronic autoimmune condition where the body’s ability to regulate
blood sugar levels is impacted due to the gradual destruction of
insulin producing beta cells by one’s own immune system.
There are 3 stages to the progression of T1D:
- In Stage 1, the autoimmune attack to the beta cells has
started, and this can be detected by the presence of 2 or more
T1D-related autoantibodies in the blood. During Stage 1, blood
sugar levels are in a normal range. At this stage, T1D is
asymptomatic.
- In Stage 2 (also asymptomatic), in addition to the presence of
2 or more T1D-related autoantibodies, blood sugar levels are now
abnormal (dysglycemia) due to the progressive loss of beta cells /
beta cell function. People diagnosed with Stage 2 T1D have a near
100% lifetime chance of progression to Stage 3 T1D, with 75% of
them progressing to it within five years.
- Stage 3 (also known as clinical stage) comes once a significant
portion of the beta cells have been destroyed. At this point,
rising blood sugar levels reach the point of clinical hyperglycemia
(which defines diabetes), and many people will experience the
classic symptoms that come with the onset of Stage 3 T1D: increased
thirst, frequent urination, unexplained weight loss, blurred vision
and generalized fatigue. Management of Stage 3 T1D requires daily
and burdensome insulin replacement therapy.
About SanofiWe are an innovative global
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