-- Zealand-invented lixisenatide shows statistically superior weight change
compared to rapid acting insulin with similar blood sugar control when
both are added to basal insulin for the intensified treatment of Type 2
diabetes
-- Results will be presented at ADA and shared by Sanofi with health
authorities worldwide, and will also be included in the US regulatory
application for lixisenatide, on track to be resubmitted in Q3 2015
COPENHAGEN, Denmark, June 6, 2015 (GLOBE NEWSWIRE) -- Zealand Pharma
A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) announces that Sanofi today
reported results from a clinical Phase IIIb trial, GetGoal Duo-2, with
Lyxumia(R) (lixisenatide). GetGoal Duo-2 has evaluated the efficacy and
safety of once-daily lixisenatide as an add-on to basal insulin for the
treatment of Type 2 diabetes patients poorly controlled on basal
insulin, versus the addition of rapid acting insulin once daily at main
meal (basal-plus) or three times daily at meal-times (basal-bolus).
In the trial, lixisenatide was shown to be non-inferior to both
comparator insulin regimens for reduction in blood sugar (HbA1c), and
statistically superior to the basal-bolus regimen for body weight
change, as co-primary endpoints. Further results from the study showed
that in the lixisenatide group of patients, documented hypoglycemia was
numerically lower than in the group receiving rapid insulin once daily
and significantly lower than in the group receiving rapid insulin three
times daily.
Britt Meelby-Jensen, President and Chief Executive Officer of Zealand
Pharma, commented: "The results from the GetGoal Duo-2 study reconfirm
the therapeutic benefits of Lyxumia(R) as a novel prandial GLP-1
agonist. For Type 2 diabetes patients treated with basal insulin,
effective control of meal-related (prandial) blood sugar is often
challenging. It is great news that Lyxumia(R) offers some advantages
over short-acting insulin in terms of both efficacy and safety as
intensification treatment for patients on insulin."
The results from GetGoal Duo-2 will be presented at the 75th Scientific
Sessions of the American Diabetes Association (ADA), taking place 5 - 9
June 2015 in Boston, MA, US under the following title:
" Advancing Basal Insulin Glargine with Prandial Lixisenatide QD vs
Insulin Glulisine QD or TID in T2DM: The GetGoal Duo-2 Evidence-Based
Trial (NCT01768559) , Rosenstock et al. Poster presentation 107-LB,
Sunday June 7, 2015.
Sanofi has informed that following the presentation of results at ADA,
data from GetGoal Duo-2 will be shared with health authorities
worldwide and be included also in the regulatory application for
lixisenatide in the US, which is on track for re-submission in the
third quarter of 2015.
Analysis of results from GetGoal-Duo II
The 26-week, randomized, open-label study compared the addition of
once-daily lixisenatide (20 ug) to optimally titrated insulin glargine
with/without metformin versus the addition of one daily injection
(basal-plus) or three daily injections (basal-bolus) of insulin
glulisine with or without metformin. The study included 894 patients
with Type 2 diabetes, who were predominantly obese and who had been
poorly controlled on basal insulin +/- oral anti-diabetics (OADs) for
at least 6 months prior to the study.
Lixisenatide was shown to be non-inferior to both comparator insulin
regimens for reduction in blood sugar (HbA1c) (LS mean difference [95%
CI]: -0.05% [-0.17 to 0.06] vs. basal-plus; 0.21% [0.10 to 0.33] vs.
basal-bolus; mITT n=890), and superior to basal-bolus for body weight
change (LS mean difference [95% CI]: -2.0kg [-2.6 to -1.4kg],
p<0.0001 vs. basal-bolus). In addition, post-prandial glucose (PPG)
was measured in patients treated before breakfast, and was
significantly reduced with lixisenatide compared with both insulin
glulisine regimens (LS mean difference [95% CI]: -37mg/dL [-59 to
-15mg/dL] vs. basal-plus; -40md/dL [-61 to -19mg/dL] vs. basal-bolus).
Documented hypoglycemia was numerically and statistically lower with
lixisenatide than with basal-plus and basal-bolus, respectively
(estimated rate ratio [95% CI]: 0.8 [0.5 to 1.1], p=0.123 vs.
basal-plus; 0.5 [0.3 to 0.7], p<0.0001 vs. basal-bolus; safety
n=894). Nausea events were higher with lixisenatide (25% of patients
receiving lixisenatide experienced one or more nausea event, 2% of
patients on basal-plus regimen, and 1% of patients on
basal-bolus).Patients receiving lixisenatide also reported vomiting
(9%) and diarrhea (7%).
For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: [email protected]
Hanne Leth Hillman, Senior Vice President for Investor Relations &
Communications
Tel: +45 50 60 36 89, email: [email protected]
About Lixisenatide
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor
agonist (GLP-1 RA) for the treatment of adult patients with type 2
diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that
is released within minutes after eating a meal. It is known to suppress
glucagon secretion from pancreatic alpha cells and stimulate
glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide is invented by Zealand with worldwide development and
marketing rights with Sanofi (SANF.PA). The product is currently
approved in 50 countries worldwide for the treatment of adults with
type 2 diabetes mellitus to achieve glycemic control in combination
with oral glucose-lowering medicinal products and/or basal insulin when
these, together with diet and exercise, do not provide adequate
glycemic control. Commercial launches have taken place in +35 countries
including in most EU countries, Japan, Brazil, Mexico and other
markets.
Lyxumia(R) is the proprietary name approved by the European Medicines
Agency and other health authorities for the GLP-1 RA lixisenatide.
Lixisenatide is an investigational product in the U.S. It will be
resubmitted to the Food & Drug Administration (FDA) in the third
quarter of 2015. The proprietary name in the U.S. is under
consideration.
About Zealand Pharma
Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) is a
biotechnology company based in Copenhagen, Denmark. Zealand has leading
expertise in the discovery, design and development of novel peptide
medicines and possesses in-house competences in clinical trial design
and management with a therapeutic focus on metabolic diseases and acute
care indications. The company is advancing a proprietary pipeline of
novel medicines alongside a partnered product and development
portfolio.
Zealand's first invented medicine, lixisenatide, a once-daily prandial
GLP-1 agonist for the treatment of Type 2 diabetes, is marketed
globally (ex-US) as Lyxumia(R) and is in Phase III development as a
single-injection combination with Lantus(R) (LixiLan), both under a
global license agreement with Sanofi. US regulatory filing for
Lyxumia(R) is planned for Q3 2015 and filing for LixiLan is planned for
Q4 2015 in the US and Q1 2016 in Europe.
Zealand's proprietary pipeline includes danegaptide (prevention of
Ischemic Reperfusion Injury) and two stable glucagon products, ZP4207
(one for treatment of severe hypoglycemia and the other for mild to
moderate hypoglycemia) as well as several preclinical peptide
therapeutics. Partnering represents an important component of strategy
to leverage in-house expertise, share development risk in large
clinical trials, provide funding and commercialize the company's
products. Zealand currently has global license agreements and
partnerships with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.
For further information: www.zealandpharma.com Follow us on Twitter
@ZealandPharma