DeveloGen Announces Completion of a Phase 1 Clinical Trial of DG3173, a Novel Somatostatin Analogue for the Treatment of Acromegaly
Goettingen, Germany DeveloGen AG, a privately held biopharmaceutical company developing novel therapeutics for the treatment of metabolic and endocrine diseases announced today that it has completed a Phase 1 trial of DG3173, also known as Somatoprim. DG3173 is a novel somatostatin analogue for potential treatment of acromegaly, carcinoid tumours as well as diabetic retinopathy. In this Phase 1 study DG3173 was generally well tolerated and safe.
DeveloGen investigated the safety, tolerability and pharmacokinetic profile of DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1 study involving 72 healthy volunteers. Individuals received up to 2000 Β΅g of DG3173 via single dose subcutaneous injection. Final results including pharmacokinetic profiles are expected in November this year.
Dr. Cord Dohrmann, Chief Executive Officer of DeveloGen said: We are very pleased that we have been able to complete all planned dose steps without reaching clinical safety or tolerability limitations. Awaiting final data analysis, we are optimistic that this Phase 1 study will support preclinical data which indicate that DG3173 has a significantly improved safety profile over currently marketed somatostatin analogues. Dr. Dohrmann continued: It is well documented that approximately 40 to 50% of acromegalic patients cannot be adequately controlled with currently available somatostatin analogues. Preclinical data indicate however that DG3173 has the potential to significantly increase the number of acromegalic patients that can be successfully treated with this drug class. Based on these preclinical and clinical results, we are confident that DG3173 is well positioned to become the best-in-class somatostatin analogue.
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 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 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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