Zealand Pharma, a Danish biotechnology company dedicated to the discovery and development of innovative peptide drugs, announced the start of the first Phase I clinical study of ZP2929.
ZP2929 is a dual acting glucagon/GLP-1 peptide agonists, invented by Zealand Pharma and with global rights out-licensed to Boehringer Ingelheim as part of a global license and research collaboration between the two companies on dual acting glucagon/GLP-1 agonists for the treatment of patients with type 2 diabetes and/or patients with obesity. Under the terms of the collaboration, Boehringer Ingelheim will finance all clinical development activities of ZP2929, including Phase I. Zealand Pharma will be responsible for conducting the first Phase I study, and Boehringer Ingelheim will be responsible for the clinical development thereafter. The advancement of ZP2929 into clinical development triggers a milestone payment to Zealand Pharma from Boehringer Ingelheim.
In validated pre-clinical models of diabetes (db/db mice) and obesity (Diet Induced Obese (DIO) mice), ZP2929 has been shown to significantly improve glycemic control (HbA1c) and induce a sustained weight loss for at least 6 weeks.
The clinical development of ZP2929 will start with a randomized, double-blind, first in human study to evaluate the safety and tolerability of single ascending daily doses of ZP2929 in healthy subjects. The study will be conducted in the United States under an Investigational New Drug (IND) application with the FDA.
Under the global license and R&D collaboration with Boehringer Ingelheim, Zealand Pharma in the first two years of the agreement (signed on 2 June 2011) is eligible to receive signature, milestone, and other payments of up to €41 million including cost reimbursements and including research funding of up to €4 million.
Further under the terms of the agreement, Zealand Pharma may receive up to EUR 376 million in total projected milestone payments for ZP2929 and additional potential milestone payments if other products are advanced through development. Zealand Pharma is also entitled to tiered royalties that range from high single to low double digits on global sales of products stemming from the collaboration and retains co-promotion rights in Scandinavia.