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The Phase I/II dose-finding study in adult patients with growth hormone deficiency investigated the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ARX201 following single-dose escalation and repeated dosing. The study analyzed 22 individuals with adult growth hormone deficiency (AGHD). The patients had not received hGH replacement therapy in the six months prior to the study.
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ARX201 was administered once weekly by subcutaneous injection. Dosing was titrated based on IGF-I response and/or safety findings. Patients were treated for up to 26 weeks. Clinical measures of body composition were taken at the end of the study period.
About ARX201
ARX201 is a long-acting recombinant human growth hormone drug candidate currently developed by Ambrx and Merck Serono for the treatment of growth hormone deficiencies. ARX201 was generated through a lead optimization process using Ambrx's ReCODE(TM) technology, which effectively enables protein medicinal chemistry. Through this approach, Ambrx was able to generate site specific mono-pegylated hGH molecules that were optimized for potency and time of action. Ambrx believes that ARX201 may have improved pharmacological performance over existing growth hormone products, including the potential for less frequent dosing.
In pre-clinical studies, ARX201 met or exceeded key end points in assays that are believed to be predictive of human pharmacokinetics and biological response. In February 2007, a Phase I/II clinical trial of ARX201 was initiated to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of this product candidate in adult patients with growth hormone deficiency following single-dose escalation and repeated dosing.
About Ambrx
Ambrx Inc. is a clinical stage biopharmaceutical company with a broad biologics platform that allows it to create best-in-class protein therapeutics, including improved versions of native proteins and therapeutic antibodies. Its most advanced product candidate, ARX201, is a long-acting human growth hormone drug candidate partnered with Merck Serono that has successfully completed initial clinical trials. The company has further validated its biologics platform through substantial partnerships with Eli Lilly and Company and Merck & Co. Ambrx is advancing a robust portfolio of product opportunities spanning multiple therapeutic areas that are highly optimized for efficacy, safety, and ease of use. For additional information, call 858.875.2400 or visit www.ambrx.com.
Media Contacts: Heidi Chokeir or David Schull Russo Partners, LLC (619)814-3512 [email protected] [email protected]
SOURCE Ambrx Inc.
