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Manufacturer of novel short bowel syndrome treatment reports positive FDA meeting
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Naia Rare Diseases Inc. successfully completed a pre-Investigational New Drug meeting with the FDA, which agreed to the company’s clinical development plans for NB1001, its long-acting glucagon-like peptide-1 receptor agonist for treating patients with short bowel syndrome, according to a press release.
NB1001 (XTEN-GLP-1) combines exenatide with a proprietary extended half-life technology, according to the press release. The agent was previously in development for type 2 diabetes, and was shown to be safe, well-tolerated and provide dose-dependent reductions in HbA1c in a previous phase 1b study. Unlike GLP-1 agonists for type 2 diabetes, which are administered at pharmacologic levels to lower blood sugar, NB1001 will be administered as a replacement therapy for short bowel syndrome, replacing endogenous GLP-1 lost by bowel resection.
“With the positive feedback we received from the FDA, we are assured that we are on the right path with the development of NB1001 and our rare disease pipeline,” H. Daniel Perez, MD, co-founder, chairman and CEO of Naia Limited, said in a press release. “Based on our discussions with the agency, we plan to initiate a phase 1 dose de-escalating clinical trial with NB1001 in the second quarter of 2016. This study design will allow us to assess both drug safety, preliminary efficacy and the doses we will use in our planned phase 2/3 pivotal study.”
Based on forecast clinical timelines, Naia expects to be able to file an NDA for NB1001 by the fourth quarter of 2018, according to the press release. The company also announced it has filed for orphan drug status with the FDA and the European Medicines Agency for NB1001 for the treatment of short bowel syndrome.
Mark Pimentel
“Short bowel syndrome has been designated a rare disease by both the FDA and the EMA, and we believe that developing NB1001 as an orphan drug in the U.S. and Europe is the most expedient and cost-effective way to bring it to market,” Mark Pimentel, MD, chairman of Naia's scientific and clinical advisory board, said in the press release. “NB1001 is the only drug in development that I am aware of that directly addresses bowel motility. As a result it should allow many patients to eliminate the need for parenteral nutrition, thus considerably improving their quality of life.”
Disclosures: Perez and Pimentel report they are employees of Naia Limited.