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Naia Rare Diseases Announces Clinical Trial Authorisation (CTA) to Initiate Clinical Trials of NB 1001 for Short Bowel Syndrome in the United Kingdom

RICHMOND, CA--(Marketwired - November 15, 2017) - Naia Rare Diseases, a biopharmaceutical company developing drugs for Short Bowel Syndrome (SBS) and other rare gastrointestinal diseases today announced that it has received Clinical Trial Authorisation ("CTA") from the Medicine and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom to initiate a clinical trial of its long-acting GLP-1 agonist, NB 1001, in adult patients with SBS.

"We are pleased to have been granted the CTA and look forward to starting trials in Europe," said H. Daniel Perez, MD, President and CEO of Naia Rare Diseases and look forward to providing further details on its progress in the near future."

We believe NB 1001 has the potential to make a significant impact on the lives of patients with SBS. NB1001 is the only drug in development that directly addresses increased bowel motility in SBS. By slowing gut transit, NB 1001 will allow for better absorption of fluids and nutrients. As a result it should allow patients to eliminate the need for parenteral nutrition, thus considerably improving their quality of life.

NB1001 will be administered as a replacement therapy (replacing endogenous GLP-1 lost by bowel resection), in contrast to GLP-1 agonists used to treat Type 2 diabetes, which are administered at pharmacologic levels in order to lower blood sugar. Lower doses of NB1001 combined with a longer half-life will provide a differentiated, safe, effective and convenient therapeutic approach for these patients.

About NB 1001
NB1001 (XTEN™-GLP-1) is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist that combines exenatide with a proprietary extended half-life technology. Licensed from Amunix Operating Inc., NB 1001 uses Amunix's proprietary "XTEN" technology to extend the half-life of the GLP-1 peptide and allows for up to once-per-month dosing, thus considerably increasing convenience for patients and caregivers. Because of lower overall exposure and dose required (as a replacement therapy) NB 1001 will have an increased safety window compared to other GLP-1 agonists, important as SBS patients are a very fragile population. NB 1001 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.

NB1001 has received orphan drug designation and has been granted an IND by the FDA.

About Naia Rare Diseases
Naia Rare Diseases is a development stage biopharmaceutical company developing novel drugs for rare gastrointestinal disorders. The company is pursuing three development programs including NB 1001 for Adult SBS, NB 1001 for pediatric SBS and NB 1002, a GLP-2 agonist, for an undisclosed orphan gastrointestinal indication. Naia Rare Diseases has been funded primarily by its parent company, Naia Limited, a company focused on building and funding new biotech companies using de-risked clinical stage assets. For more information, please visit www.naiapharma.com.

Contact:
Mark Bagnall
Naia Pharmaceuticals
510-926-8237
[email protected]

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