Patient recruitment completed for phase II trial with glepaglutide for treatment of short bowel syndrome
(Thomson Reuters ONE) -
Press release - No. 1/2017
Patient recruitment completed for phase II trial with glepaglutide for treatment
of short bowel syndrome
* Results of the phase II trial are expected mid 2017
* Glepaglutide is a novel GLP-2 analogue with the potential to improve
treatment of patients with short bowel syndrome
Copenhagen, February 6, 2017 - Zealand Pharma A/S ("Zealand") announces that the
last patient has been dosed in a phase II proof-of-concept, dose-finding trial
with glepaglutide[1] for the treatment of short bowel syndrome (SBS). SBS is a
serious condition involving intestinal function failure following the surgical
removal of large parts of the small or large intestine due to cancer, ischemia
or Crohn's disease. Patients suffering from SBS have compromised intestinal
absorptive capacity and lack the ability to maintain protein-energy, fluid,
electrolyte and nutrient balances on a conventional diet. Many are therefore
dependent on intravenous supplements in the form of fluids, salts and nutrition
delivered through a central catheter to maintain body functions.
Zealand is developing glepaglutide as a novel GLP-2 analogue, with a half-life
in humans of up to 17 hours, for the treatment of SBS. Significant preclinical
effects on the small and large bowels have been demonstrated, and glepaglutide
was concluded to be safe and well tolerated in a phase 1 clinical trial.
Glepaglutide has been designed to be stable in liquid formulations for easy and
convenient daily subcutaneous dosing in an injection pen.
The primary objective of the phase II trial is to assess the effect of
glepaglutide on improving patients' intestinal absorption capacity. Results from
the phase II trial are expected in the summer of 2017.
"Patients with short bowel syndrome have reduced quality of life due to constant
diarrhea and dependency on daily parenteral support. SBS is associated with a
high risk of sepsis, blood clots, liver damage and renal impairment, so we are
desperately in need of better treatment options," says Palle Jeppesen, Principal
Investigator of the phase II trial and Professor MD, Department of
Gastroenterology, Copenhagen University Hospital, Denmark.
In a comment about this release, Adam Steensberg, Senior Vice President and
Chief Medical and Development Officer of Zealand, said: "We are very happy to
announce that patient recruitment has been completed for the phase II dose-
finding trial with glepaglutide for short bowel syndrome. Living with short
bowel syndrome can be very burdensome, with some patients being dependent on
intravenous infusion of liquids and nutrition for up to 16 hours per day. We are
thankful for the commitment the clinical staff and patients have demonstrated in
order to reach this milestone and look forward to seeing the results of the
trial later this year. We are committed to bringing this product candidate
through full development and hope to be able to offer this group of patients a
new, convenient treatment option."
*****
For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel.: +45 51 67 61 28, e-mail: bmj(at)zealandpharma.com
Mats Blom, Senior Vice President, Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl(at)zealandpharma.com
About short bowel syndrome
Short bowel syndrome (SBS) is a complex chronic disease characterized by severe
loss of intestinal function. SBS can result from either physical removal of
portions of the small intestine and colon or from loss of function as a result
of bowel damage. The primary underlying causes of SBS are Crohn's disease, colon
cancer, ischemia and radiation.
Patients with SBS have compromised intestinal absorptive capacity and lack the
ability to maintain protein-energy, fluid, electrolyte and nutrient balances on
a conventional diet. Many are therefore dependent on increased and frequent
intake intravenous supplements in the form of fluids, salts and nutrition
delivered through a central catheter to maintain body homeostasis. There are
currently estimated to be 10,000-20,000 SBS patients in the EU and a similar
number in the US.
Patients dependent on regular intravenous support experience a number of serious
and life-threatening complications associated with their disease and treatment.
These include shortened life expectancy as well as high risk of sepsis and other
infections, blood clots, liver damage and renal impairment. In addition,
patients have markedly reduced quality of life due to constant diarrhea and
dependency on daily intravenous support, which can take up to 16 hours
overnight, causing sleep disturbance and restricting their daily activities.
Teduglutide (Gattex(®)/Revestive(®)), a GLP-2 receptor agonist, was approved in
2012 and launched in 2014 in both the US and Europe as the first medicine
indicated for the treatment of SBS.
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 license collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and
a pipeline of proprietary product candidates that primarily target specialty
diseases with significant unmet needs.
Zealand'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 Adlyxin(TM) in the US and Lyxumia(®) in the rest of
the world. Lixisenatide has been developed in a fixed-ratio combination with
basal insulin glargine (Lantus(®)) and is marketed as Soliqua(TM) 100/33 in the
US and has been approved as Suliqua(TM) in Europe.
Zealand's pipeline includes: dasiglucagon* (ZP4207, single-dose rescue
treatment) for acute, severe hypoglycemia (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
hypoglycemia control and diabetes management (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] Glepaglutide is a proposed International Nonproprietary Name (pINN).
01-17_0206 - Final patient - glepaglutide Ph II trial:
http://hugin.info/136974/R/2076173/780743.pdf
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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: 06.02.2017 - 15:25 Uhr
Sprache: Deutsch
News-ID 522161
Anzahl Zeichen: 8006
contact information:
Town:
Glostrup
Kategorie:
Business News
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"Patient recruitment completed for phase II trial with glepaglutide for treatment of short bowel syndrome"
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