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February 26th, 2009
DeveloGen Reports Positive Phase 1 Clinical Trial Results for DG3173
Goettingen, Germany — February 26th, 2009:
DeveloGen AG, a privately held
biopharmaceutical company developing novel therapeutics for the treatment of
metabolic and endocrine diseases today 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." Dr. Dohrmann continued: "Our extensive preclinical characterization of DG3173
in combination with these Phase 1 study results provide a solid basis for further
development of DG3137 in various indications, in particular in acromegaly and carcinoid
tumors as well as diabetic retinopathy."
For further information please contact:
DeveloGen AG
Carsten Dehning
Chief Financial Officer
Tel: +49 551 50558 514
Fax: +49 551 50558 586
E-mail: info@develogen.com
Marie-Curie-Str. 7
37079 Goettingen
www.develogen.com
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About DG3173
DG3173 is a new chemical entity somatostatin analogue (SSA) based on its novel amino acid
composition and its unique backbone cyclization technology used for stabilization of the
peptide. During extensive preclinical testing, DG3173 has demonstrated a unique receptor
binding and pharmacological profile which is significantly differentiated from SSAs that are
currently marketed or in clinical development. In particular, DG3173 has demonstrated an
improved side effect profile with minimal adverse effects on the gastrointestinal tract and
metabolic control. Furthermore, assessment of growth hormone secretion in cultured
human somatotroph adenoma tissue treated with DG3173 suggests that it has the potential
to significantly increase the response rate of acromegalic patients to SSA therapy. These
preclinical and clinical results position DG3173 as best-in-class SSA in a market that
currently generates more than US$ 1 billion in sales annually.
DeveloGen
DeveloGen AG is a biopharmaceutical company engaged in the discovery and development
of novel therapeutics for the treatment of metabolic and endocrine diseases. The Company
has a highly innovative and deep preclinical discovery pipeline addressing the key drivers in
the development of diabetes and obesity such as insulin resistance and loss of insulin-
producing beta cells. This pipeline includes two programs at advanced stages of lead
optimization, a small molecule inhibitor program based on a novel and proprietary target
to address insulin resistance (type 2 diabetes) and a growth factor targeting beta-cell
regeneration (type 1 and type 2 diabetes). In addition, the Company is developing DG3173
(Somatoprim), a potentially best-in-class somatostatin analogue for the treatment of
acromegaly, carcinoid tumors and diabetic retinopathy, which is currently in Phase 1
clinical development. DeveloGen is based in Goettingen, Germany. For more information
on DeveloGen, please visit
www.develogen.com.
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