Naia Rare Diseases appoints Professor Palle Bekker Jeppesen to its Scientific Advisory Board

Naia Rare Diseases, Inc. appoints Professor Palle Bekker Jeppesen to its Scientific Advisory Board

— Appointment Completes Company’s Scientific Advisory Board —

RICHMOND, Calif., January 18, 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.

“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.

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.

 

Contact:
Mark Bagnall, Naia Pharmaceuticals
510-926-8237
mbagnall@naiapharma.com

Naia Rare Diseases Forms Scientific Advisory Board Comprised of Internationally Renowned Experts and Scientists

Naia Rare Diseases Inc, a subsidiary of Naia Limited, Forms Scientific Advisory Board Comprised of Internationally Renowned Experts and Scientists

— Company Appoints Advisor of Patient and Physician Relations —

RICHMOND, Calif., January 7, 2016 – Naia Limited, an international drug development company today announced that its subsidiary, Naia Rare Diseases, has formed a Scientific Advisory Board (SAB) comprised of internationally renowned experts and scientists in gastrointestinal diseases, particularly Short Bowel Syndrome (SBS). Mark Pimentel, MD, FRCPC, member of Naia’s board of scientific and clinical advisors and director of the gastrointestinal motility program and laboratory at Cedars-Sinai, is joined by 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, 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. Naia also appointed Andrew Jablonski, CEO, Short Bowel Syndrome Foundation, advisor for patient and physician relations.

“The high caliber of Naia Rare Diseases’ SAB is a clear indication of the great potential of our rare diseases platform,” said H. Daniel Perez, M.D., co-founder, chairman and chief executive officer of Naia Limited. “This advisory group has the skills and experience to provide us with the necessary guidance to rapidly advance our drug candidates through clinical testing and bringing them to market.

Naia Rare Diseases is developing drugs 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 that such distinguished colleagues have agreed to join me on the Naia Scientific Advisory Board” said Dr. Pimentel.  “Their dedication and expertise in treating patients with SBS is reflected by the large number of patients they treat and their large referral base.   I look forward to working with them to bring new and promising therapies to SBS patients in need.”

“We would also like to welcome our new advisor of patient and physician relations, Mr. Andrew Jablonski” said Dr. Perez. “Mr. Jablonski will be critical in our efforts to enhance Naia’s interactions with SBS patients. Understanding their needs and concerns is paramount for the successful development of our SBS treatment, NB 1001.”

“Naia is developing very promising and innovative treatments for SBS,” said Andrew Jablonski, “As an SBS patient and an SBS patient advocate, I applaud the focus on the potential for reducing and even eliminating the need for parenteral nutrition.”

Biographies

Mark Pimentel, MD, FRCPC is director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai. Board certified in internal medicine and gastroenterology, Dr. Pimentel has been awarded various investigator-driven grants related to gastrointestinal motility. His primary research interests involve irritable bowel syndrome and its relationship to small intestinal motility and bacterial overgrowth. Other interests include gastric motility in diabetes. Dr. Pimentel is a member of several professional organizations, including the Medical Council of Canada, American Gastroenterological Association and American College of Gastroenterology. He has written articles for such peer-reviewed publications as the Archives of Internal Medicine, American Journal of Gastroenterology, Journal of Clinical Gastroenterology and Digestive Diseases and Sciences. Dr. Pimentel received his bachelor’s and medical degrees from the University of Manitoba in Winnipeg, Canada. He completed his internal medicine residency at the University of Manitoba Health Science Center. His fellowship in gastroenterology is from the University of California, Los Angeles Integrated Training Program.

Stuart S. Kaufman, MD, is medical director, Pediatric Transplantation in the Transplant Institute of MedStar Georgetown University Hospital. Dr. Kaufman is a pediatric gastroenterologist by training and has a special interest in intestinal failure and rehabilitation, small bowel transplantation and multi-organ abdominal transplantation. He participated in several studies in pediatric short bowel syndrome and has authored several original research publications in pediatric short bowel syndrome and intestinal transplantation, and numerous book chapters on these topics.

Mark DeLegge, MD, is a professor of medicine at the Medical University of South Carolina in Charleston, SC. He is a gastroenterologist who is also board certified in nutrition and has practiced clinically for 24 years. He has extensive experience in caring for patients with Short Bowel Syndrome and other complicated gastrointestinal diseases. He has over 100 publications and significant clinical trial experience including multiple funded grants. He has published extensively in nutrition and short bowel syndrome. Dr. DeLegge has extensive experience in drug development and interactions with regulatory agencies both in the US and globally. He has also served as the safety director and drug safety monitoring board chairman for a number of industry trials. He is a sought after public speaker both nationally and internationally.

John DiBaise, MD is professor of medicine at Mayo Clinic in Scottsdale, Arizona, in the gastroenterology and hepatology department.  He has expertise in the areas of gastrointestinal motility disorders and intestinal failure, particularly short bowel syndrome. He has authored many peer-reviewed publications and book chapters, and edited several books. His fellowship in gastroenterology and hepatology is from the University of Nebraska Medical Center and he completed his internal medicine residency at the University of Iowa Hospitals and Clinics. He received his medical degree at University of Nebraska Medical Center.

Farooq Rahman, BSc, PhD, FRCP is a consultant gastroenterologist at University College Hospital and honorary senior Lecturer at University College London. He is has extensive experience in general gastroenterology and hepatology. His subspecialty interests include inflammatory bowel disease, clinical nutrition & intestinal failure and endoscopy. He studied medicine at The Royal Free Hospital School of Medicine in London and completed his gastroenterology specialist training on the North East London rotation. He obtained his Ph.D. studying the immunopathogenesis of inflammatory bowel disease. He remains actively involved in undergraduate/postgraduate teaching and research at UCLH/UCL, regularly presents at national and international meetings, and has multiple high impact peer-reviewed publications.

Andrew E. Jablonski is the founder and chief executive officer of the Short Bowel Syndrome Foundation, Inc. (SBSF), a 501(c)(3) public charity organization that supports the community of patients and caregivers are impacted by the rare intestinal disease Short Bowel Syndrome (SBS). Established in December 2010 in Lincoln, NE, SBSF helps educate, support patients who live with SBS, their families, and the healthcare practitioners who help care for them. Mr. Jablonski works closely with other industry related organizations such as the National Organization of Rare Disorders and leading medical centers to help raise awareness of SBS, the Foundation, and the patients it serves. Mr. Jablonski obtained his BA degree in human relations and is a graduate student in mental health studies and counseling.

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.

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.

 

Investor Contact:
Mark Bagnall, Naia Pharmaceuticals
510-926-8237
mbagnall@naiapharma.com

Media Contact:
Andreas Marathovouniotis
917-957-1174
amarathis@marathisllc.com