Developing Novel Drugs for Rare Gastrointestinal Disorders
The company was founded in 2014 with a mission to develop effective new drugs for rare gastrointestinal diseases.
Our initial focus is the treatment of Short Bowel Syndrome (SBS).
We have identified a new approach which we believe will enable SBS patients to reduce their dependence on Total Parenteral Nutrition (TPN), thereby vastly improving their quality of life.
Naia Rare Diseases works very closely with the Short Bowel Syndrome Foundation and we are honored to have the Foundation’s CEO, Andrew Jablonski, on our Board of Advisors, advising on Patient-Physician Relations.
SBS is a serious disorder arising from a shortened small intestine.
The causes are varied but the results are very serious – reduction of a functioning bowel mass to below that minimally necessary to balance supply & demand of essential body needs, leading to intestinal failure.
The disease is characterized by diarrhea and nutritional deprivation, with patients too often dependent upon TPN to manage their nutritional needs.
TPN involves intravenous infusion for up to several hours every day which, aside from the negative impact on quality of life, carries side effects as well as high risk of systemic infections via the central intravenous line.
Given the serious potential ramifications for patients dependent upon TPN, Naia Rare Diseases is pursuing an original approach to treating the disease, with the aim of reducing or eliminating the need for this onerous procedure.
Currently, there are three approaches to the treatment of SBS:
- Managing symptoms: using anti-diarrhea medications etc, while attempting to wean patients off TPN.
- Surgery: various surgical techniques to add length to the small intestine
- Increasing surface area of the remaining gut: a drug currently on the market stimulates the gut villi to grow and thus increases the surface area for nutritional absorption.
Naia Rare Diseases is developing a fourth approach:
Slowing the transit of food through the gut by administering low concentrations of GLP-1, a natural brake to stomach contractions and gut transit.
GLP-1 acts immediately to reduce gut transit, reduce or eliminate diarrhea and reduce or eliminate the need for TPN.
Naia’s lead drug, NB 1001, is a long acting injectable GLP-1 analogue specifically developed to treat patients with SBS.
Licensed from Amunix Operating Inc, NB 1001 uses Amunix’s proprietary XTEN® technology to extend the half-life of the GLP-1 peptide, allowing for once or twice-per-month dosing, thus considerably increasing convenience for patients and caregivers.
NB1001 is patent protected and has received orphan drug designation by the FDA.
Naia has assembled an advisory board of some of the most notable experts in the disease to help guide the development of NB 1001. They have been intimately involved in designing the Phase 1 clinical study which will start in 2018.
Naia’s second drug, NB 1002, is a long acting GLP-2 analog with similar proprietary extended half-life technology.
NB1002 is being developed for SBS (adult and pediatric). Using this approach we expect the concentrations of NB 1002 needed to be lower and safer than other GLP-2 approaches on the market and in development, while providing the added convenience of twice a month (instead of daily) administration.
NB 1002 is patent protected.