Press release – No. 5 / 2022
Zealand Pharma Presents Data from Phase 3 Trial of
Dasiglucagon in Congenital Hyperinsulinism at the 60th Annual ESPE
Meeting
- Dasiglucagon significantly reduced the requirement for
intravenous glucose to maintain glycemia in newborns and infants
with CHI (Part 1 of Phase 3 trial)
- Dasiglucagon reduced time in hypoglycemia and enabled
discontinuation of intravenous glucose in most infants and limited
the need for pancreatectomy (Part 2 of Phase 3 trial)
- Results support the potential for dasiglucagon to be a novel,
effective, and well tolerated treatment for infants with CHI
dependent on intravenous glucose
Copenhagen, DK and Boston MA, U.S. September 19, 2022 –
Zealand Pharma A/S (CVR-no. 20045078,) a biotechnology company
focused on the discovery and development of innovative
peptide-based medicines, today announced that clinical results from
the two-part Phase 3 trial of dasiglucagon for the treatment of
congenital hyperinsulinism (CHI) in newborns and infants up to 12
months of age were presented at the 60th annual European Society
for Paediatric Endocrinology (ESPE) meeting, held in Rome,
September 15-17, 2022. Topline results from Part 1 of the trial
were previously announced in May 2022 (Company Announcement No. 22
/ 2022).
“Children with CHI can experience significant and permanent
neurologic complications as a result of hypoglycemia, and many
infants are dependent on intravenous glucose, and in some cases
require pancreatectomy, to maintain euglycemia. I am encouraged by
the results from Part 1 of this Phase 3 study demonstrating that
dasiglucagon treatment resulted in a significant reduction in
glucose infusion rate, and to see this trend continue in Part 2, in
which the majority of infants could reduce or in many cases be
weaned off of IV glucose infusion and also avoid pancreatectomy,”
said Diva D. De León-Crutchlow, M.D., M.S.C.E., Chief of
the Division of Endocrinology and Diabetes and Director of the
Congenital Hyperinsulinism Center at Children's Hospital of
Philadelphia and a study principal investigator. “Though congenital
hyperinsulinism is an incredibly challenging disease to manage, the
efficacy and safety of dasiglucagon observed in this Phase 3 trial,
support its potential as a new treatment option for children with
CHI.”
“We are very pleased to present the compelling results from the
Phase 3 study of dasiglucagon in newborns and infants up to 12
months of age at ESPE 2022. This study deepens our understanding of
dasiglucagon’s potential as an innovative treatment for CHI
patients,” said David Kendall, M.D., Chief Medical Officer of
Zealand Pharma. "Zealand is committed to addressing the unmet needs
of children living with CHI and we look forward to engaging with
regulatory authorities and submitting a New Drug Application for
dasiglucagon in 2023.”
The abstracts of the oral presentations are available at
eurospe.org and the data are summarized as follows:
Title: Dasiglucagon Significantly Reduces Requirement for
Intravenous Glucose in Children with Congenital Hyperinsulinism
ages 7 Days to 12 MonthsAuthors: Diva D. De Leon, Indraneel
Banerjee, David M. Kendall, Sune Birch, Eva Bøge, Jelena Ivkovic
& Paul S. Thornton
Presentation Highlights: In Part 1 of the Phase 3 trial,
dasiglucagon significantly reduced the requirement for intravenous
(IV) glucose to maintain glycemia in neonates and infants with CHI
and reduced glucose requirements to levels that potentially allow
for discontinuation of IV glucose support.
- Dasiglucagon significantly reduced the mean IV glucose infusion
rate (GIR) in the last 12 hours of the 48 hour treatment period by
55% as compared to placebo (4.3 mg/kg/min for dasiglucagon and 9.4
mg/kg/min for placebo with a treatment difference of 5.2 mg/kg/min;
p=0.0037). Dasiglucagon also reduced GIR over the entire 48-hour
treatment period by 3.5 mg/kg/min compared to placebo
(p=0.0107).
- Dasiglucagon treatment resulted in a reduction of 31 g/day in
total carbohydrate intake (IV and gastric) compared to placebo (107
g/day for dasiglucagon vs 138 g/day for placebo; p = 0.024), a 22%
reduction in carbohydrate calories.
- Dasiglucagon was observed to be well tolerated in Part 1 of the
trial, with skin reactions and gastrointestinal disturbances as the
most frequently reported adverse events (no serious adverse events
reported).
Title: Dasiglucagon Treatment Over 21 days in Infants
with Congenital Hyperinsulinism Results in Glycaemic Stability and
Reduces Requirement for Intravenous GlucoseAuthors:
Indraneel Banerjee, Diva D. De Leon, David M. Kendall, Sune Birch,
Eva Bøge, Jelena Ivkovic & Paul S. Thornton
Presentation Highlights: In the 21-day open-label Part 2
of the Phase 3 trial, continuous subcutaneous infusion of
dasiglucagon in infants with CHI reduced IV glucose requirements,
time in hypoglycaemia and enabled discontinuation of IV glucose in
most infants, obviating the need for subtotal pancreatectomy for
glycaemic stability.
- Dasiglucagon enabled reduction and either periodic or permanent
discontinuation of IV glucose infusion in 10 out of 12
infants.
- Seven infants, who did not require pancreatectomy, were
completely weaned off IV glucose at the completion of the
trial.
- During the 21-day treatment with dasiglucagon, continuous
glucose monitoring (CGM) measures of hypoglycaemia trended lower
with median time <70 mg/dL reduced from 7.0% to 5.2% and <54
mg/dL reduced from 1.9% to 0.88%. There was no increase in
hyperglycaemia.
- The safety profile of dasiglucagon in Part 2 was consistent
with Part 1, with no adverse event requiring discontinuation of
treatment and no serious adverse events reported.
About the Phase 3 Trial
The Phase 3 trial (17103) was designed to investigate the
potential for chronic dasiglucagon infusion, delivered
subcutaneously via a pump, to prevent hypoglycemia in newly
diagnosed children with CHI who are dependent on intravenous
glucose. The trial was conducted in two parts. Part 1 was a
double-blind, placebo-controlled two-period crossover with
treatment periods of 48 hours each. Part 2 was an open-label,
single-arm study of dasiglucagon treatment for an additional 21
days. The primary objective of the overall trial was to reduce or
eliminate the need for intensive hospital treatment, reduce the
frequency of dangerously low blood glucose (hypoglycemia) and the
need for constant feeding, and to potentially delay or eliminate
the need for pancreatectomy. (ClinicalTrials.gov: NCT04172441).
About CHI
Congenital hyperinsulinism (CHI) is a rare pediatric disease
that affects newborns, infants and children. In CHI the insulin
producing cells in the pancreas secrete excess insulin regardless
of glucose levels, resulting in severe and recurrent hypoglycemia
throughout childhood. Early treatment is necessary to limit the
risk of irreversible brain injury and long-term neurologic
deficits. Current treatments are limited and may be insufficient to
adequately control hypoglycemia.
About Dasiglucagon
Invented by Zealand Pharma, dasiglucagon is a glucagon analog
that is stable in aqueous solution and is thus suitable for
administration via chronic subcutaneous infusion via pump. In 2017,
both the U.S. Food and Drug Administration (FDA) and the European
Commission granted orphan drug designation for dasiglucagon for the
treatment of CHI.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology
company focused on the discovery and development of peptide-based
medicines. More than 10 drug candidates invented by Zealand have
advanced into clinical development, of which two have reached the
market and three candidates are in late-stage development. The
company has development and partnerships with a number of blue-chip
pharma companies as well as commercial partnerships for its
marketed products.
Founded in 1998 and headquartered in Copenhagen, Denmark,
Zealand has a team in the U.S. For more information about Zealand’s
business and activities, please visit
http://www.zealandpharma.com.
Forward-Looking StatementsThis press release contains
“forward-looking statements”, as that term is defined in the
Private Securities Litigation Reform Act of 1995, as amended, that
provide Zealand Pharma’s expectations or forecasts of future events
regarding the research, development and commercialization of
pharmaceutical products. These forward-looking statements may be
identified by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,”
“plan,” “possible,” “potential,” “will,” “would” and other words
and terms of similar meaning. You should not place undue reliance
on these statements, or the scientific data presented. The reader
is cautioned not to rely on these forward-looking statements. Such
forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions, which may cause actual results to differ
materially from expectations set forth herein and may cause any or
all of such forward-looking statements to be incorrect, and which
include, but are not limited to, the occurrence of adverse safety
events; risks of unexpected costs or delays; unexpected concerns
that may arise from additional data, analysis or results obtained
during clinical trials; failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; regulatory authorities may require additional
information or further studies, or may fail to approve or may delay
approval of our drug candidates or expansion of product labelling;
failure to obtain regulatory approvals in other jurisdictions;
product liability claims; and the direct and indirect impacts of
the ongoing COVID-19 pandemic on our business, results of
operations and financial condition. If any or all of such
forward-looking statements prove to be incorrect, our actual
results could differ materially and adversely from those
anticipated or implied by such statements. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from our expectations in any forward-looking statement.
All such forward-looking statements speak only as of the date of
this press release and are based on information available to
Zealand Pharma as of the date of this release. We do not undertake
to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof. Information
concerning pharmaceuticals (including compounds under development)
contained within this material is not intended as advertising or
medical advice.
Contact:
Anna Krassowska, PhDVice President, Investor Relations &
Corporate CommunicationsZealand PharmaEmail:
ank@zealandpharma.com
David Rosen (U.S. Media)Argot PartnersEmail:
media@zealandpharma.com
Zealand Pharma AS (NASDAQ:ZEAL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Zealand Pharma AS (NASDAQ:ZEAL)
Historical Stock Chart
From Sep 2023 to Sep 2024