RICHMOND, CA—(Marketwired – January 26, 2016) – Naia Limited, an international drug development company today announced that its subsidiary, Naia Rare Diseases, has appointed Professor Palle Bekker Jeppesen, MD, Head of Research at the Department of Gastroenterology, Rigshospitalet, Copenhagen, to its Scientific Advisory Board. Professor Jeppesen is a recognized expert in the treatment of Short Bowel Syndrome (SBS) and has been a leading researcher developing new therapeutic approaches for the disease. He was the principal investigator in the clinical studies that led to the approval of teduglutide (Gattex®), to date the only FDA–approved product for SBS.
Professor Jeppesen joins current Scientific Advisory Board members, Mark Pimentel, MD, FRCPC, professor of medicine and director of the gastrointestinal motility program and laboratory at Cedars–Sinai, Mark DeLegge, MD, professor of medicine at the Medical University of South Carolina, John DiBaise, MD, professor of medicine at Mayo Clinic, Scottsdale, Arizona, Stuart Kaufman, MD, professor of pediatrics and medical director, pediatric transplantation, Georgetown Medical Center and Farooq Rahman, BSc, Ph.D., FRCP, consultant gastroenterologist & lead physician for intestinal failure, University College Hospital, London.Â
“We are excited that Professor Jeppesen has agreed to join Naia Rare Diseases Scientific Advisory Board,” said H. Daniel Perez, M.D., co–founder, chairman and chief executive officer of Naia Limited. “He is an acknowledged expert in the treatment of SBS and his addition to our already distinguished board is a testament to the importance of what we are doing.”
Naia Rare Diseases is developing therapeutics for SBS and other rare gastrointestinal diseases. The company intends to file an IND for its lead program, NB 1001 in the second quarter of 2016, and will conduct a Phase 1b open label, single dose, dose de–escalation study in adult SBS patients in the second half of 2016. The company believes that a single Phase 2/3 study will be required for product approval.
“I am very happy to join such a group of distinguished colleagues on the Naia Scientific Advisory Board,” said Professor Jeppesen. “I believe Naia is working on potentially significant treatments for SBS and I look forward to working with Naia to bring these therapies to SBS patients in need.”
Professor Palle Bekker Jeppesen is the Head of Research at the Department of Gastroenterology at Rigshospitalet in Copenhagen, Denmark. He is also an Affiliate Professor in the Department of Nutrition, Exercise and Sports at the unit for Clinical and Experimental Nutrition, University of Copenhagen.
His major research interests include patients with short bowel syndrome and intestinal failure with a recent focus on novel therapies for their management, rehabilitation and care. He was principal investigator in the international, multicenter, phase 2 and 3 program, which led to approval of the drug teduglutide by the FDA and EMA to treat SBS. Professor Jeppesen graduated in medicine from the University of Copenhagen, Denmark, in 1989 and completed his residency in medical gastroenterology at the Rigshospitalet in Copenhagen. He completed his PhD thesis, entitled The significance of the fatty acid chain–length for the clinical effect in the enteral and parenteral nutrition in patients with malabsorption in 1998 and his Doctor's Degree, entitled Intestinal insufficiency and failure, in 2003.
About NB 1001
NB 1001 is a proprietary long–acting version of the GLP–1 agonist, exenatide, developed specifically to treat SBS. 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. Exenatide, has been studied in patients with SBS by Dr. Pimentel and demonstrated efficacy by slowing gastric contractions as well as bowel movements and improving nutritional status leading to discontinuation of parenteral nutrition. NB 1001 was previously developed to treat type 2 diabetes and in a 70 patient clinical study demonstrated efficacy with no observed side effects.Â
About Naia Limited
Naia Limited builds and funds new biotech companies using de–risked clinical stage assets. Naia's structure spreads overhead costs and resources during early development of assets thus reducing costs and time. The company has an international base of operations to develop therapeutics better, faster and more inexpensively — in proximity to target markets. Naia's operating structure includes a Cayman Island–based management company and several holding companies that focus on development activities of like assets. The company is developing a diverse portfolio of therapeutics that address regional and global unmet medical needs in various markets with an initial focus on rare and metabolic diseases. For more information, please visit www.naiapharma.com.