Positive Phase 2a results with microdoses of dasiglucagon support use in a dual-hormone artificial pancreas system
(Thomson Reuters ONE) -
Company announcement - No. 16/2017
Positive Phase 2a results with microdoses of dasiglucagon support use in a dual-
hormone artificial pancreas system
* Dasiglucagon is a potential first-in-class glucagon analogue for pump use in
the management of type 1 diabetes
* Data from this first Phase 2a trials indicate that
dasiglucagon increases blood sugar levels across all tested dose levels
* Dasiglucagon was observed to be safe and well tolerated in the trial
* Results from the second Phase 2a trial on the use of dasiglucagon in the
dual-hormone artificial pancreas system, iLet(TM), are expected at the end
of June 2017
Copenhagen, May 23, 2017 - Zealand Pharma ("Zealand") announces positive results
from a Phase 2a trial following administration of the multiple-dose version of
dasiglucagon in adult patients with type 1 diabetes. Dasiglucagon is a glucagon
analogue fully owned by Zealand with a unique stability profile in liquid
formulation and a potential first-in-class glucagon analogue suitable for pump
use.
The Phase 2a trial was initiated in December 2016 to assess the efficacy, safety
and tolerability of different doses of the concentrated formulation of
dasiglucagon for pump use. The primary objective was to characterize the
pharmacokinetic and pharmacodynamic properties of dasiglucagon 4 mg/ml
formulated with preservatives.
The trial was a double-blind, randomized, four-period, sequential complete
crossover trial in patients with type 1 diabetes. Four different doses of
dasiglucagon were tested under normal blood glucose level (euglycemia) and low
blood glucose level (hypoglycemia) conditions and with reference to responses
observed with freshly reconstituted glucagon (NCT02916251).
A clear dose-response with increases in blood glucose levels was observed across
the broad dose range tested, allowing for titration of dasiglucagon to
counteract present or incumbent hypoglycemia. All dasiglucagon doses provided
clinically relevant mean increases in blood glucose (mean plasma glucose
increases of 20 mg/dl or more) under both euglycemic and hypoglycemic
conditions.
Dasiglucagon and Glucagon were observed to be safe and well-tolerated in the
trial, with no injection site reactions observed with dasiglucagon. Nausea and
vomiting were the most frequent side effects observed, predominantly at the
higher dose-levels, with both dasiglucagon and Glucagon.
Adam Steensberg, Chief Development and Medical Officer of Zealand, comments:
"We are very pleased with the Phase 2a results. Dasiglucagon in a dual-hormone
artificial pancreas system holds the potential for patients to live more
spontaneously with tight glucose control, without the constant fear of
hypoglycemia and worry about their disease. Such systems can potentially
transform type 1 diabetes management. We look forward to the results of the next
Phase 2a study with dasiglucagon in the Beta Bionics iLet(TM) system at the end
of June and to progressing this opportunity further into development for the
future benefit of patients."
Type 1 diabetes dual hormone artificial pancreas system
People with type 1 diabetes suffer from insulin deficiency and inappropriate
glucagon secretion.
Both hormones are essential to ensure stable and healthy blood glucose levels.
Consequently, patients must monitor and adjust their blood sugar levels to
remain in proper glycemic control, as both high and low blood glucose may affect
their health, both in the short and long term.
As glucagon is not yet available in a liquid formulation, no pumps capable of
mimicking a healthy pancreas are available today. Dasiglucagon is a potential
first-in-class glucagon analogue with a unique stability profile in liquid
formulation suitable for pump use. Zealand is working with a dual-hormone pump
containing insulin and dasiglucagon that can decrease and increase blood sugar
levels, guided by an algorithm to control blood glucose levels without patient
intervention. In June 2016 Zealand and Boston based Beta Bionics announced a
partnership to progress the clinical development of iLet(TM), a state-of-the-art
dual-hormone artificial pancreas device.
Zealand expects to report top-line results from a second Phase 2a trial, which
is conducted under this partnership, by the end of June 2017, after which we
will decide on the next clinical development steps.
For further information, please contact:
Britt Meelby Jensen, CEO and President
Tel.: +45 51 67 61 28, e-mail: bmj(at)zealandpharma.com
Mats Blom, Executive Vice President, Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl(at)zealandpharma.com
16-17_0523 Dasiglucagon positive Phase 2a:
http://hugin.info/136974/R/2106878/800003.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Zealand Pharma via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.05.2017 - 08:40 Uhr
Sprache: Deutsch
News-ID 544198
Anzahl Zeichen: 5684
contact information:
Town:
Glostrup
Kategorie:
Business News
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"Positive Phase 2a results with microdoses of dasiglucagon support use in a dual-hormone artificial pancreas system"
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