DeveloGen Reports Positive Phase 1 Clinical Trial Results for DG3173

02-Mar-2009 - Germany

DeveloGen AG reported positive results from a Phase 1 study for DG3173, a novel somatostatin analogue. The results of the study indicate that DG3173 has an excellent safety and tolerability profile at all doses administered.

The Phase 1 trial was designed as a randomized, double-blind, placebo controlled, single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of DG3173. In total, 72 healthy male volunteers received between 10 to 2000 micrograms of DG3173 or placebo via subcutaneous injection. All doses of DG3173 were safe and well tolerated; the maximal tolerated dose has not been reached. In addition, neither serious adverse events nor dose-related adverse events were observed. Most frequently reported adverse events included unspecific headaches in six cases. Furthermore, gastrointestinal events and local injection site reactions were reported in three cases, respectively. Observed adverse events were generally mild and resolved spontaneously.

Analysis of pharmacokinetic properties of DG3173 revealed maximal DG3173 plasma concentrations within one hour of administration and a proportional increase of exposure with dose. An exploratory analysis of plasma growth hormone levels was consistent with a suppression of growth hormone release by DG3173.

Dr. Cord Dohrmann, Chief Executive Officer of DeveloGen commented: "The results of this initial Phase 1 study further support our working hypothesis that DG3173 has a superior safety and tolerability profile compared to currently marketed somatostatin analogues. In addition, we demonstrated a favourable pharmacokinetic profile for DG3173 and generated preliminary data indicating that DG3173 is able to suppress growth hormone release in humans."

https://www.bionity.com/en/news/97586/develogen-reports-positive-phase-1-clinical-trial-results-for-dg3173.html