Zealand initiates Phase IIa clinical trial with dasiglucagon in a dual-hormone artificial pancreas system from Beta Bionics
(Thomson Reuters ONE) -
Press Release - No. 7 / 2016
Zealand initiates Phase IIa clinical trial with dasiglucagon in a dual-hormone
artificial pancreas system from Beta Bionics
* An automated delivery system with both insulin and glucagon holds potential
to become a paradigm shift in the treatment of type 1 diabetes
* In December, Zealand initiated two Phase IIa trials, to test dasiglucagon's
potential in a dual-hormone artificial pancreas system
* Results from both trials are expected in H1 2017
Copenhagen, 13 December 2016 - Zealand Pharma (Zealand) today announced that it
has dosed the first patients in its Phase IIa clinical trial with
dasiglucagon[1] in a dual-hormone artificial (or bionic) pancreas system from
Beta Bionics. Dasiglucagon is a Zealand-invented glucagon analogue with a unique
stability profile in liquid formulation. The multiple-dose version of
dasiglucagon is intended for use in a dual-hormone artificial pancreas system to
better control hypoglycaemia and, potentially, hereby provide insulin treated
diabetes patients with options for easier and more effective management of their
disease.
The Phase IIa trial is the fourth Phase II trial initiated by Zealand this year,
demonstrating the significant progress in Zealand's pipeline of proprietary
product candidates.
People with type 1 diabetes depends on a complex daily insulin regimen to
control their blood glucose. They must regularly track and adjust their blood
sugar levels to reduce the acute and chronic risks associated with hypo- and
hyperglycaemia. A dual-hormone artificial (or bionic) pancreas system, which
automatically delivers insulin and glucagon, aims to mimic the function of a
healthy pancreas[2].
Steven J. Russell, MD, Massachusetts General Hospital Diabetes Center in Boston,
MA, USA, and Principal Investigator:
"Our previous studies have shown that a dual-hormonal bionic pancreas can
provide very effective management of glycemia in people with type 1 diabetes.
All of our previous studies have used glucagon that have very limited stability,
so the glucagon pump had to be refilled daily. More importantly, the unstable
glucagon formulations will not meet the regulatory requirements to be approved
for use in a bionic pancreas. This Phase IIa study will test the effectiveness
of the stable glucagon analogue dasiglucagon in the dual-hormone bionic
pancreas, comparing it with the unstable glucagon formulation that we have used
in all of our previous studies. Demonstrating the effectiveness of a stable
glucagon formulation or analogue, such as dasiglucagon, is an essential step
towards making a dual-hormone bionic pancreas available to patients."
Adam Steensberg, Senior Vice President, Chief Medical & Development Officer,
Zealand:
"We are happy to have initiated our fourth Phase II trial this year, showing
significant progress in our clinical pipeline of medicines that we fully own and
develop ourselves. This is the first trial evaluating Zealand's glucagon
analogue, dasiglucagon, in the clinic for use in the dual-hormone artificial
pancreas, under development by Beta Bionics and Boston University. Such a system
has the ultimate potential to offer people with diabetes on insulin therapy more
efficacious, safer and easier blood sugar control."
Zealand entered into a collaboration with Beta Bionics, a Boston-based company,
earlier this year. Beta Bionics is developing a dual-hormone artificial (bionic)
pancreas system based on advanced technology that was conceived and refined at
Boston University and has been undergoing clinical trials for nearly 10 years at
the Massachusetts General Hospital and, more recently, Stanford University, the
University of North Carolina and the University of Massachusetts. The technology
is being integrated at Beta Bionics into a pocket-sized wearable medical device
called the iLet(TM).
The Phase IIa trials
The aim of the Phase IIa clinical trial with Beta Bionics is to assess, for the
first time, the safety, efficacy and tolerability of dasiglucagon as part of the
Beta Bionics dual-hormone artificial (bionic) pancreas system in adult patients
with type 1 diabetes, compared to a recombinant market glucagon. In
collaboration with Beta Bionics and Boston University, the trial is conducted at
the Massachusetts General Hospital Diabetes Research Center in Boston, MA, USA,
with MD Steven J. Russell as Principal Investigator.
Earlier this month, Zealand initiated another Phase IIa trial with the aim of
assessing PK and PD responses after administration of the multiple-dose version
of dasiglucagon in adult patients with type 1 diabetes. The first patients have
been dosed.
The Phase IIa trials are designed to provide the foundation for longer clinical
trials with the multiple-dose version of dasiglucagon in the dual-hormone
artificial pancreas system. Results from both trials are expected in H1 2017.
For further information on the Phase IIa trials, see:
ClinicalTrials.gov Identifier: NCT02916251
ClinicalTrials.gov Identifier: NCT02971228
*****
For further information, please contact
Adam Steensberg, Senior Vice President, Chief Medical and Development Officer
Tel.: +45 50 60 36 01, e-mail: ast(at)zealandpharma.com
Mats Blom, Senior Vice President, Chief Financial Officer
Tel: +45 31 53 79 73, e-mail: mabl(at)zealandpharma.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology
company focused on the discovery, design and development of innovative peptide-
based medicines. Zealand has a portfolio of medicines and product candidates
under licence collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and
a pipeline of proprietary product candidates that primarily target specialty
diseases with significant unmet needs.
The company's first invented medicine, lixisenatide, a once-daily prandial GLP-
1 analogue for the treatment of type 2 diabetes, is licensed to Sanofi.
Lixisenatide is marketed as Lyxumia(®) outside the United States and approved as
Adlyxin(TM) in the United States. Lixisenatide has been developed in a fixed-
ratio combination with basal insulin glargine (Lantus(®)) and is approved as
Soliqua(TM) 100/33 in the United States, and in Europe a CHMP positive opinion
recommendation was given in November (Suliqua(TM) is the brand name in Europe).
Zealand's proprietary pipeline includes: dasiglucagon* (ZP4207) (single-dose
rescue treatment) for acute, severe hypoglycaemia (phase II); glepaglutide*
(ZP1848) for short bowel syndrome (phase II); dasiglucagon* (ZP4207) (multiple-
dose version) intended for use in a dual-hormone artificial pancreas system for
better hypoglycaemia control and diabetes management (in phase II); and other
earlier-stage clinical and preclinical peptide therapeutics.
Zealand is based in Copenhagen (Glostrup), Denmark. For further information
about the company's business and activities, please visit www.zealandpharma.com
or follow Zealand on Twitter (at)ZealandPharma.
* Dasiglucagon and glepaglutide are proposed International Nonproprietary Names
(pINN).
--------------------------------------------------------------------------------
1 Dasiglucagon is a proposed International Nonproprietary Name (pINN)
[2] Russel et al. "Outpatient glycemic control with a bionic pancreas in Type 1
diabetes", New England Journal of Medicine (2014)
07-16_1213 Zealand initiates Phase IIa trial with dasiglucagon:
http://hugin.info/136974/R/2064427/774914.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: 13.12.2016 - 08:15 Uhr
Sprache: Deutsch
News-ID 512422
Anzahl Zeichen: 8808
contact information:
Town:
Glostrup
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 177 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Zealand initiates Phase IIa clinical trial with dasiglucagon in a dual-hormone artificial pancreas system from Beta Bionics"
steht unter der journalistisch-redaktionellen Verantwortung von
Zealand Pharma (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
