13 dec: SAS vil hente yderligere besparelser for 700 mio. svenske kr.
13 dec: Aktier/tendens: Mærsk og SAS kan tage rampelyset
13-12-2016 08:15:28

Zealand initiates Phase IIa clinical trial with dasiglucagon in a dual-hormone artificial pancreas system from Beta Bionics

Relateret indhold
15 mar - 
Onsdagens aktier: DSV og Mærsk til tops samt bundrekord..
15 mar - 
Zealand FY: Leverer igen røde tal - men lidt bedre end ..
15 mar - 
Aktier/middag: Banker kravler op i ellers let vigende C..
Relateret debat
22 mar - 
De franske opkøbere må føle det er ..
22 mar - 
Jep - det er indimellem et noget spøjst handelsm..
22 mar - 
Du mener 2018 vel?

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 iLetTM.

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@zealandpharma.com

Mats Blom,

Senior Vice President, Chief Financial Officer

Tel: +45 31 53 79 73, e-mail:

mabl@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 @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


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

Vedhæftet fil: 774914.pdf

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
20 mar
ZEAL
Uniform Formulary Beneficiary Advisory Panel   Det amerikanske forsvar's sundhedsorganisation skal d..
9
21 mar
ZEAL
Lad os tag en simple P/E betragtning baseret på Alpehus's tal. Lad os se 5 år i krystalkuglen efters..
7
21 mar
ZEAL
Sanofi har både i europa og i USA udtaget patent på lixisenatide tilbrug omid neurodegenrative sygdo..
6
17 mar
ZEAL
Det lyder da ganske udemærket, men lad os nu se, hvor langt det bærer - mindre kan nu også gøre det!..
6
22 mar
ZEAL
Sanofi afrapportere Q1 resultat d. 28 April, 2017. Her vil jeg formode at de giver en eller anden fo..
5
17 mar
ZEAL
Der kommer ikke mindre end 3 fase 2 resultater inden Q2 2017, dvs. de kan potentielt stå med 3 komme..
5
17 mar
ZEAL
Du overvurderer den kursmæssige effekt af fase II resultater, som er indpriset efter "forventede suc..
4
16 mar
ZEAL
I øvrigt ligger jeg stadig i et pænt plus med mine Zeal aktier, da jeg har erhvervet mig de fleste ..
4
16 mar
ZEAL
Jeg vil nu mene 180 er tallet, hvor Novo og Zealands kurser krydser hinanden!?!
4
16 mar
ZEAL
Ja - det er sgu helt forfærdligt - K1. Nogen må gøre noget. Salgt lortet. Anmeld dem til politiet. M..
4

NKT/Jyske: Ny forventning efter afsluttet opkøb kan skuffe

22-03-2017 16:39:17
Der er risiko for en skuffelse, når NKT Holding kommer med den opdaterede prognose for NTK Cables, som selskabet har lovet efter afslutningen af opkøbet af ABB's højspændingsforretning.Det vurderer aktieanalytiker Janne Vincent Kjær fra Jyske Bank.- Vi ser en risiko for, at den nye guidance vil overraske negativt med konsensus' forventninger til margin på 13,5 pct. - mere end 1 procentpoint over v..

Novo-rival overvejer frasalg af kopiforretning - citat

22-03-2017 13:14:00
Det franske medicinalselskab Sanofi, der er blandt Novo Nordisks store konkurrenter, kigger på et frasalg af sine forretningsaktiviteter inden for kopimedicin.Det skriver Bloomberg News, hvis kilder oplyser, at Sanofi har hyret banker for at se på et eventuelt frasalg.Der er tale om et frasalg, som menes at kunne indbringe i størrelsesordenen 2-2,5 mia. euro, skriver Bloomberg News.Selve salgsproc..

Mærsk: EU skyder afgørelse om Hamburg Süd-køb

22-03-2017 11:32:57
EU's konkurrencemyndigheder har udskudt en afgørelse vedrørende Maersk Lines køb af Hamburg Süd til den 10. april. Det skriver Bloomberg News.Beslutningen om at rykke deadline kommer, efter at selskaberne har givet indrømmelser den 20. marts, skriver Bloomberg./ritzau/FINANSJakob Dalskov +45 33 30 03 35 Ritzau Finans, E-mail: finans@ritzau.dk , www.ritzaufinans.dk

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/middag: Trump-bekymringer rammer alle i C20 undtagen én
2
Nordea på sløj dag: Her er tre grunde til at aktierne fortsætter op
3
Aktier/tendens: Mærsk, FLS og banker i fokus i ventet faldende marked
4
Aktier/åbning: Mærsk og Genmab trækker godt ned i bredt fald
5
Sparekasse fjerner 27.602 stavnsbundne kunders millionafkast - citat

Relaterede aktiekurser

Zealand Pharma A/S 105,00 0,0% Aktiekurs uændret
Zealand Pharma AS DKK1 15,48 -3,9% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
23. marts 2017 05:23:35
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20170322.1 - EUROWEB2 - 2017-03-23 05:23:35 - 2017-03-23 05:23:35 - 1 - Website: OKAY

Når du besøger Euroinvestor.dk accepterer du, at der anvendes cookies, som vi og vores samarbejdspartnere benytter til funktionalitet, statistik og markedsføring. Læs mere om cookies på Euroinvestor.dk her

x