NephRx, a Kalamazoo-based biotech startup that is developing a product for use in renal disease and inflammatory gastro-intestinal disorders, has gotten good news.
The company's lead product, known as NX001, has been awarded orphan drug status by the U.S. Food and Drug Administration after it did well in animal models.
An orphan drug is one that is intended to treat a rare disease, one that affects fewer than 200,000 people in the United States. Makers of orphan drugs receive tax credits and marketing exclusivity incentives. Without those, drug makers otherwise would have little incentive to develop the drugs as the market for them is too small for them to recoup their research investment in the product.
NX001 is a kidney growth factor peptide, or protein that regulates cellular growth.
The orphan drug designation comes for NX001's use in the prevention of delayed graft function in kidney transplant recipients, which happens in about 20 to 25 percent of the approximately 14,000 renal transplants performed in the United States each year.
At this time there is no treatment for delayed graft function. When patients experience delayed graft function there often is an increase in rejection of the transplanted kidney.
"NX001 has demonstrated promising activity in improving kidney function in preclinical models of acute renal failure," says James Koziarz, Ph.D., CEO of
NephRx Corp. "We look forward to initiation later this year of our clinical program to test its effectiveness in helping patients achieve better kidney function post-transplant."
The kidney is one of the few human organs with the potential for self-repair and NephRx researchers believe the outcome of the work they are doing has the potential to stimulate improved renal functioning in a number of renal disorders.
NephRx Corporation is dedicated to the discovery and development of therapeutic products for the treatment of acute kidney failure and other renal disorders and diseases of the gastrointestinal tract, including mucositis, Crohn's disease and ulcerative colitis.
Writer: Kathy Jennings
Source: James Koziarz, NephRx Corp
Enjoy this story?
Sign up for free solutions-based reporting in your inbox each week.