Date: 2015-09-09
Type of information: Results
phase: 1
Announcement: results
Company: Zealand Pharma (Denmark)
Product: ZP4207
Action
mechanism: glucagon analog.
Disease: treatment of mild to moderate hypoglycemia in diabetes patients
Therapeutic area: Metabolic diseases
Country: Germany
Trial
details: The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending doses of ZP4207 administered s.c. to healthy volunteers to evaluate the safety, tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of ZP4207 or placebo in a 3:1 treatment allocation at trial site. (NCT02390141)
Latest
news: * On September 9, 2015, Zealand Pharma announces that results from a clinical Phase Ib trial with its novel glucagon analogue, ZP4207 show good safety and tolerability after multiple dosing. In addition, it was shown that ZP4207 leads to clinically relevant increases in blood glucose levels. ZP4207, which was invented and is wholly-owned by Zealand, has shown a good stability profile in liquid formulation, supporting its potential as a product immediately ready for use. The randomized, double-blind and placebo-controlled Phase Ib trial was conducted by Zealand at a clinical diabetes center in Germany and enrolled 24 healthy volunteers. The trial objectives were primarily to evaluate safety and tolerability and secondarily to assess pharmacokinetics and pharmacodynamics of ZP4207 after multiple dosing. Participants in the trial received three different doses of ZP4207, each over 5 consecutive days. The trial was funded under a $ 1.8 million grant from the Helmsley Charitable Trust to support preclinical and initial clinical activities related to the multiple-dose version of ZP4207. Results from a Phase I trial with a single-dose version of ZP4207 were announced in June this year, showing good safety and tolerability after single-dosing in both healthy volunteers and Type 1 diabetes patients. Further, effects were shown in raising blood glucose levels in Type 1 diabetes patients after an insulin-induced hypoglycemic event. Zealand is progressing preparations towards a next clinical trial with ZP4207 as a single-dose ready-to-use rescue pen to treat severe hypoglycemia events. Based on the results from the repeat dosing Phase Ib trial, Zealand will evaluate additional options for further development of a multiple-dose version of ZP4207. * On May 20, 2015, Zealand Pharma announced that it has advanced a multiple-dose version of its novel stable glucagon analogue, ZP4207, into clinical development. The ZP4207 multiple-dose version is for the treatment of mild to moderate hypoglycemia in diabetes patients, and could also be an essential component in a dual-hormone artificial pancreas system. The new Phase Ib clinical trial initiated with ZP4207 is a randomized, double blind and placebo-controlled study to evaluate primarily the safety and tolerability of the compound after multiple dosing. Secondary endpoints will measure the pharmacokinetics and pharmacodynamics (blood sugar levels) of ZP4207 after multiple dosing. The trial is conducted at a clinical diabetes center in Germany and is planned to enroll 24 healthy volunteers, who will receive three different cohorts of daily doses of ZP4207, each over 5 days. Results from this study is expected in the second half (H2) of 2015. To support preclinical and initial clinical activities related to the multiple-dose version of ZP4207, Zealand has been granted $ 1,833,000 from the Helmsley Charitable Trust. The grant will be paid in three installments with USD 600,000 to be received upfront and the rest in the first half (H1) of 2016.
