9 Meters Biopharma Launches Trial for Short Bowel Syndrome Drug

If you were born with an abnormally short digestive tract, or had to have your bowel surgically shortened, a young Raleigh pharmaceutical company is developing a drug to help you regain lost nutritional benefit from food digestion.

The company, 9 Meters Biopharma, Inc. (NASDAQ:NMTR), is launching an early clinical trial for an experimental drug designed to help people absorb more nutrients when their digestive tract is significantly shortened through surgery or at birth.

The gastrointestinal disease-focused company, named for the length of the digestive tract, is initiating a Phase 1b/2a trial of NM-002, a long-acting injectable glucagon-like peptide-1 (GLP-1) agonist designed specifically to exploit gut motility effects in patients with short bowel syndrome (SBS). It works by slowing digestive transit time.

SBS is a rare, life-threatening disorder that occurs when the digestive tract is significantly shortened through surgery or at birth, thus impairing the body’s ability to absorb nutrients. The company’s drug is designed specifically to slow the time it takes food to travel through the digestive system, thus allowing for improved nutrient absorption even with the shortened digestive tract.

Current treatment options for patients with SBS typically involve reliance on parenteral support, in which patients receive intravenous nutrients, hydration or electrolytes instead of by mouth, which is extremely burdensome.  NM-002 is designed to reduce this reliance and improve patients’ quality of life.

The trial, which will take place at Cedars-Sinai Medical Center in Los Angeles, is an open-label study evaluating the safety and tolerability of three escalating doses of NM-002 in adult patients. The first patient is expected to be dosed in July 2020, with topline results expected in the first half of 2021.

Drug gets FDA Orphan Designation, could reduce dosing

The company says NM-002 has demonstrated safety with an extended half-life of up to 30 days in a 70-patient clinical study and has received Orphan Designation by the U.S. Food and Drug Administration.

"In developing NM-002, we've used Amunix's proprietary XTEN technology to extend the half-life of the GLP-1 peptide, which allows the drug to be injected only once or twice per month,” explained Patrick H. Griffin, M.D., FACP, chief medical officer of 9 Meters. “This considerably increases convenience for patients and caregivers compared to other GLP-2 drug products on the market for SBS which must be dosed daily." 

John Temperato, president and chief executive officer of 9 Meters since April 2020, called the advancement into the Phase 1b/2a trial “a major milestone for 9 Meters as we strive to create a more effective treatment option for patients with SBS.” 

“Not only is SBS a life-threatening disease when untreated, but the current treatment standard of parenteral support is insufficient, as it results in an extremely low quality of life for patients,” added Temperato. “We look forward to developing NM-002 to reduce reliance on intravenous supplementation, and therefore give patients the freedom to live a less-restricted lifestyle and reduce their financial burden."

Temperato is the former CEO of Israel-based RDD Pharma. It merged in October 2019 with Raleigh clinical-stage pharmaceutical developer Innovate Biopharma to create 9 Meters. Temperato was instrumental in the commercial and operational buildout of Salix Pharmaceuticals, also focused on GI treatments, which culminated in Salix's acquisition for $16 billion in 2015.

In an interview with the North Carolina Biotechnology Center at the time of the 9 Meters formation last year, Termperato said the founders made a strategic decision to keep the company headquartered in the Triangle. “It’s a great place to recruit people to, but a hard place to recruit people from, because they don’t want to leave,” he said.

The patent rights covering the use of the GLP-1 agonist technology to treat short bowel syndrome are owned by Cedars-Sinai and are exclusively licensed by that medical center to Naia Rare Diseases, a wholly owned subsidiary of 9 Meters.

Several GI therapies are being developed by 9 Meters, including Larazotide, the first drug to enter a Phase 3 registration trial in celiac disease. Its unique potential has resulted in Fast Track designation from the FDA.