November 14, 2008
Ambrx Announces Positive Data From Phase I/II AGHD Study
Ambrx, a clinical stage biopharmaceutical company, has announced positive Phase I/II clinical trial data demonstrating that ARX201, the company's long-acting human growth hormone analogue developed in collaboration with Merck Serono, normalized insulin-like growth factor I levels while delivering an acceptable safety and tolerability profile in adults with growth hormone deficiency.
The Phase I/II study of ARX201, analyzed 22 adult growth hormone deficiency (AGHD) patients who had not received hGH replacement therapy in the six months prior to the trial. ARX201 was administered by subcutaneous injection on a weekly basis for 26 weeks. IGF-I levels increased to normal values and remained such throughout the course of the trial, the company said.
According to the company, patients experienced a mean truncal fat loss of 5.6% and a mean total body fat loss of 1.3%. The mean increase in lean body mass was 3.6%. ARX201 was well tolerated with temporary pain at the injection site as the only reported side effect. No neutralizing antibodies to either PEGylated GH or to native GH were detected throughout the study. The results of this trial support further evaluation of ARX201 as an option for the treatment of adult growth hormone deficiency.
Stephen Kaldor, president and CEO of Ambrx, said: "We are very excited by these promising clinical results and are hopeful that ARX201 will provide a better treatment option for patients with AGHD that currently require daily injections.
"Additionally, this study provides proof of concept that protein analogues made using Ambrx's ReCODE technology have retained potency with an improved pharmacological profile over conventional protein therapeutics. This opens the door for Ambrx to create more effective protein-based therapies across a broad range of treatment classes."