Pipelinedescriptions

Lyxumia® (lixisenatide) for Type 2 diabetes – Marketed (licensed to Sanofi)

Description

Lyxumia® (lixisenatide) is a once-daily prandial GLP-1 receptor agonist, invented by Zealand and with global commercial rights licensed to Sanofi. The product has a pronounced effect on post-prandial glucose and is indicated for use in combination with basal insulin, including Lantus® (insulin glargine), the world’s most prescribed basal insulin, and/or oral anti-diabetic medicines.

Status

Approved and launched by Sanofi in Europe (March 2013), Japan (September) and several other countries. In the US, an NDA is planned submitted in 2015 after completion of the ELIXA CV study.

Key events/milestones 

Quarterly sales numbers.
Additional launches in new markets.
Results from ELIXA study outcome.
US NDA submission.

Lyxumia® (lixisenatide) for Type 2 diabetes – Marketed (licensed to Sanofi)

Description

Fixed-ratio combination of Lantus® and Lyxumia® administered once-daily in a disposable pen. 

Status

LixiLan Phase III clinical development program started in January 2014. Evaluated in large Phase IIb study in
323 patients. 

Key events/milestones 

Presentation of Phase IIb results in 2014. Completion of the LixiLan Phase III program.
US NDA submission.

ZP2929 for Type 2 diabetes and/or obesity – In Phase I (Zealand proprietary asset)

Description

ZP2929 is a once-daily glucagon/GLP-1 dual-acting peptide agonist for the treatment of diabetes and/or obesity.

ZP2929 has shown, in preclinical studies, to improve glycemic control (HbA1c) equivalent to that of marketed GLP-1s, while showing a superior and sustained weight loss. 

Status

The continued development program for ZP2929 is under strategic review. The program is conducted under an initial new drug application (IND) with the FDA.

Key events/milestones 

As a next step Zealand will present its preferred strategy for the continued Phase I development and design to the FDA, including results from additional preclinical studies. 

Danegaptide for ischemia reperfusion injuries – In Phase II (Zealand proprietary asset)

Product/disease indication

A novel Zealand invented dipeptide gap junction modifier with cardioprotective properties.

Status 

Zealand is evaluating danegaptide in a Phase II Clinical Proof-of-Concept study for its effect in the protection against ischemic reperfusion injuries. The study is expected to enroll up to 600 patients with an acute myocardial infarction (STEMI), undergoing PCI. 

Key events/milestones

Results are expected in the 2nd half of 2015. 

ZP1848 for inflammatory bowel disease – Ready for Phase II (Zealand proprietary asset) 

Product/disease indication

A GLP-2 peptide agonist demonstrating regenerative effect on the intestinal epithelial surface and an ability to enhance bowel function. 

Status

Completed Phase Ib and ready for
Phase II. 

Key events/milestones

It is part of Zealand’s current prioritization to only advance ZP1848 under a partnership.

Elsiglutide for chemotherapy induced diarrhea – In Phase II (partnership with Helsinn) 

Description

A novel, potent and selective GLP-2 peptide receptor agonist in development for the prevention of chemotherapy induced diarrhea. 

Status

Helsinn has evaluated elsiglutide in a clinical Phase IIa Proof-of-Concept study for the prevention of chemotherapy induced diarrhea in colorectal cancer patients. Based on favorable results from this study, Helsinn is preparing the advance of elsiglutide into a Phase IIb dose-finding study. 

Key events/milestones 

Initiation of Phase IIb by Helsinn later
in 2014.

Conduction of large observational multicenter, multinational study to better understand the incidence of chemotherapy induced diarrhea in colorectal and breast cancer patients.

ZP1480 (ABT-719) for acute kidney injury – In Phase II (licensed to Abbvie)

Product/disease indication

An MSH melanocortin peptide agonist for the prevention of acute kidney injury following major surgery. 

Status 

Abbvie is conducting a Phase IIb program to confirm positive results from an earlier study of ZP1480 in the prevention of acute kidney injury. 

Key events/milestones

Results from Phase IIb program.

Preclinical programs

Our preclinical activities include around 10 peptide programs and a number of early stage projects. The majority of projects relate to the therapeutic field of cardio-metabolic indications, and new projects are targeting other disease areas, where peptide therapeutics promise to have large potential.

Two of the preclinical projects are under partnerships. One covers our collaboration with Boehringer Ingelheim on novel glucagon/GLP-1 dual agonists for the treatment of diabetes and/or obesity, which is progressing towards the selection of a new lead candidate from the portfolio of novel compound designs invented under the two-year 

research agreement of the collaboration (completed in June 2013), including compounds designed for once-weekly dosing. Another is our collaboration with Lilly on joint design and development of potentially novel therapeutic peptides against an undisclosed target with therapeutic relevance for the treatment of Type 2 diabetes and obesity.

One late-stage proprietary preclinical program covers our novel glucagon analogue for the treatment of severe hypoglycemia (episodes of critically low blood sugar levels) in diabetic patients. This Zealand invented peptide analogue has shown unique physico-chemical properties as well as efficacy and a 

pharmacokinetic profile similar to native glucagon, making it suitable for a liquid formulation. These properties leave the potential for its use in a easy-to-use rescue pen and potentially as an essential component in an artificial pancreatic system. Zealand is currently preparing for the advancement of this medicine into clinical development.

Another advanced preclinical program is our dual acting GLP-1-gastrin agonist for the treatment of diabetes. This peptide has potentially disease preventive properties as it has demonstrated in preclinical animal models its potential to preserve pancreatic beta-cell function and insulin secretion.