Clinical Data Show Long-Acting Human Growth Hormone ARX201 is Safe and Well...( Long-Acting hGH Analogue Requires...)

Long-Acting hGH Analogue Requires Only Weekly Dosing

SAN DIEGO, Nov. 13 /PRNewswire/ -- Ambrx Inc. today announced Phase I/II clinical trial data demonstrating that ARX201, the company's long-acting human growth hormone (hGH) analogue developed in collaboration with Merck Serono, normalized insulin-like growth factor I (IGF-I) levels while delivering an acceptable safety and tolerability profile in adults with Growth Hormone deficiency. The results of this trial support further evaluation of ARX201 as an option for the treatment of adult growth hormone deficiency (AGHD).

In the 26-week study, normal levels of IGF-I, a marker for hGH activity, were maintained with injections given once a week. The clinical trial results were presented today at the International Congress of Endocrinology Conference in Rio de Janeiro by Andrew Hoffman, M.D., Professor of Medicine and Vice Chair for Academic Affairs at Stanford University.

"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," said Stephen Kaldor, Ph.D., president and CEO of Ambrx. "Additionally, this study provides proof of concept that protein analogues made using Ambrx's ReCODE(TM) 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."

The Phase I/II study of ARX201, analyzed 22 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. Patients experienced a mean truncal fat loss of 5.6 percent and a mean total body fat loss of 1.3 percent. The mean increase in
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