IND submission to initiate clinical trials of NB 1001 (XTEN-GLP1) for treatment of Short Bowel Syndrome announced by Naia Rare Diseases
MOUNTAIN VIEW, CA–(Marketwired – December 19, 2016) – Amunix is pleased to announce that Naia Rare Diseases, a biopharmaceutical company developing drugs for Short Bowel Syndrome (SBS) and other rare gastrointestinal diseases has announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1b clinical trial for its long-acting XTENylated GLP-1 agonist, NB 1001 in adult patients with SBS.
NB-1001 (XTEN-GLP1), is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist created by combination of exenatide with Amunix’s proprietary extended half-life (XTEN®) technology. XTEN-GLP1 was previously developed to treat type 2 diabetes and in a 70 patient clinical study demonstrated efficacy and an extended half-life up to 30 days.
NB 1001 will be administered as a replacement therapy, replacing endogenous GLP-1 lost by bowel resection. Lower doses of NB1001 combined with a longer half-life are expected to provide a differentiated, safe, effective and convenient therapeutic approach for these patients. NB 1001 has been designed to target up to monthly dosing, thereby considerably increasing the convenience for patients and caregivers.
“The filing of XTEN-GLP1 for this target indication is great news and further exemplifies the broad utility of XTEN technology to improve the efficacy of patient treatment regimens currently impeded by the use of therapeutics that have short half-life”, said Volker Schellenberger, Amunix’s Chief Executive Officer. “We are very pleased to see the advancement of this licensed molecule by Naia into the clinic for this targeted need”.
Amunix, based in Mountain View, CA, is a privately held biotechnology company focused on the discovery and development of novel therapeutics with improved in vivo half-lives. Amunix’s half-life extension technology is based on XTEN — hydrophilic, unstructured, biodegradable proteins that impart a number of favorable properties upon the molecules to which they are attached. XTEN can be recombinantly fused or chemically conjugated to peptides, proteins, and other pharmaceuticals. In addition to the advantages of reduced dosing frequency, XTENylation also stabilizes plasma drug concentrations, which often results in increased efficacy as well as reduced side effects. Two genetically fused XTENylated products have been tested clinically. VRS-859 (exenatide-XTEN) has been tested through Phase 1 in the treatment of diabetes and VRS-317 (human growth hormone-XTEN), for which enrollment has been completed for the Phase 3 trial. Amunix is also working with other partners, including Eli Lilly, Biogen, Roche, Janssen, Baxalta, Ambrx, Zealand, Noxxon, Naia and other undisclosed partners in a wide range of therapeutic areas. Amunix is developing an internal pipeline of ProTIA (Protease Triggered Immune Activator) immuno-oncology therapeutics. ProTIAs are bispecific molecules that bind tumor antigens and T cells. ProTIAs are administered as long-acting prodrugs that can be activated in the tumor environment by tumor-associated proteases. Amunix is actively seeking partnerships for application of its XTEN technology and its ProTIA platform. For additional information about the company, please visit www.amunix.com.
Volker Schellenberger, Ph.D.
President and CEO