Proceedings of the National Academy of Sciences Report Superiority of Human Growth Hormone Generated with Ambrx Technology Phase 1/2 Study Evaluated ARX201 in Growth Hormone-Deficient Patients
SAN DIEGO, May 25, 2011 /PRNewswire/ -- Ambrx Inc. today announced that data from a Phase 1/2 study, published online ahead of print on May 16 by Proceedings of the National Academy of Sciences, demonstrate the safety, efficacy and superior dosing frequency of ARX201, a sustained action human growth hormone, compared to therapy with native hormone.
The study evaluated adult GH-deficient (AGHD) patients treated with ARX201, which was generated with Ambrx's ReCODE™ technology. ARX201 was shown to have a half-life in patients of four days and to potentially be suitable for weekly dosing, which is superior to current therapy that requires daily dosing. Insulin-like growth factor 1 (IGF-1) a clinically validated biomarker of growth hormone activity was restored to normal ranges with weekly dosing. ARX201 was found to be safe and well tolerated with repeat dosing.
"This report provides clinical validation of Ambrx technology, which constitutes site-directed protein medicinal chemistry," said Ho Cho, Ph.D., Chief Technology Officer of Ambrx. "ARX201 represents a best in class growth hormone optimized for efficacy, safety and patient convenience. Additionally, Ambrx has successfully scaled the manufacturing process to support advanced product development and eventual commercialization."
The study enrolled 22 AGHD patients who had not received growth hormone replacement therapy in the past six months. Patients received weekly injections of ARX201 for up to 26 weeks. ARX201 dose was determined through measurement of IGF-1, the standard indicator for growth hormone therapy. Efficacy in patients included decreased truncal fat mass and total body fat, while lean body mass levels increased.
ARX201 is a long-acting rDNA-derived human GH drug candidate being developed by Ambrx for the treatment of growth hormone deficiencies. A Phase 2b clinical trial of ARX201 in adult patients with growth hormone deficiency was successfully completed in 2010. This and previous studies have demonstrated that ARX201 has improved pharmacological performance relative to existing growth hormone drugs, including the potential for much less frequent dosing. ARX201 was generated through a process using Ambrx's ReCODE™ technology, which enables optimal protein medicinal chemistry. Through this approach, Ambrx discovered site specific mono-PEG hGH molecules optimized for potency and duration of action.
Ambrx Inc. is a clinical stage biopharmaceutical company using its transformational technology in discovery of best-in-class therapeutics, including antibody drug conjugates and novel proteins of unprecedented potential. The company is developing ARX201, a sustained action growth hormone that has successfully completed Phase 2b clinical trials. Ambrx has validated its biologics platform through partnerships with Eli Lilly, Merck-Serono, Pfizer, Roche and Merck & Co Inc. Ambrx is advancing a robust portfolio of product candidates optimized for efficacy, safety and ease of use in multiple therapeutic areas. For additional information, visit www.ambrx.com.
SOURCE Ambrx Inc.