Raleigh-based biopharmaceutical company 9 Meters Biopharma formed just over a year ago, and while slowed by the pandemic, hopes to make significant progress this year in proving the effectiveness of its treatment for celiac disease.
About 1% of the global population suffers from celiac disease, which causes a damaging immune response to gluten in the small intestine, said 9 Meters CEO John Temperato.
“It’s a very sizable population,” Temperato said in an interview with The News & Observer, and there is currently no cure for it.
But 9 Meters, which focuses on treatments for rare digestive disorders, believes its drug Larazotide could provide relief for people suffering from the disease. Larazotide is currently in Phase 3 trials, and Temperato said it’s one of the most advanced clinical trials for a celiac disease treatments. The treatment is only being tested on individuals who are maintaining a gluten-free diet.
Those with the disease must follow a strict diet that avoids foods with gluten, a protein found in staple ingredients like wheat and barley. The disease causes gluten to damage the lining of the small intestine, leading to symptoms like diarrhea, fatigue, abdominal pain and nausea.
“It’s a debilitating disease,” Temperato said that can disrupt someone’s day-to-day life. “Unlike high blood pressure or high cholesterol, you know, if somebody is not adhering to (those medical issues), they don’t feel daily issues.”
With celiac disease, it can be a daily nuisance — and maintaining a perfectly gluten-free diet can be expensive. Accidental cross contamination is also common.
“Thirty to 40 percent of patients who are on a gluten-free diet still have celiac symptoms,” Temperato said. “Probably the biggest issue is inadvertent exposure, whether it’s toothpaste or lip balm. (Gluten) is in everything.”
The oral treatment, taken before meals three times a day, attempts to prevent the inflammatory response that gluten causes in the intestines of people with celiac disease.
“You would take our drug with each meal — breakfast, lunch, and dinner — with the goal of (stopping inflammation), while you’re eating and digesting for a couple hours,” he said.
Status of clinical trial
The company should have been closer to completing its clinical trial by this point.
The trial, like many clinical trials in the past year, has been hampered by the COVID-19 pandemic. At one point, more than two-thirds of all trials were being delayed because of struggles to recruit individuals into programs, Fierce Biotech reported.
“We were absolutely impacted by COVID,” Temperato said. “The last thing that patients really wanted to do, when the world was locked down, was to go volunteer in a clinical study.”
At the moment, that means the trial likely won’t be completed until the last few months of this year. Data from the trial, which the U.S. Food and Drug Administration will use to determine its effectiveness, would most likely be available sometime next year, Temperato said.
If the data readout is good, the company hopes to seek approval for its drug in 2023, Temperato added.
Larazotide previously received fast-track designation from the FDA, N.C. Biotech reported. The designation expedites the FDA’s review process for drugs that treat serious conditions or unmet medical needs.
9 Meters formed last year after Raleigh-based Innovate Biopharmaceuticals merged with the Israeli firm RDD Pharma and California’s Naia Rare Diseases. (The company’s name is a reference to the approximate length of an adult’s gastrointestinal tract.)
Temperato was the CEO of RDD Pharma before the merger, and prior to that had been an executive at Salix Pharmaceuticals.
In addition to its celiac disease treatment, the company is also developing a treatment for short bowel syndrome.
The company’s stock, which trades on the Nasdaq stock exchange, was up more than 115% over the past year, going from 58 cents a share on June 1, 2020 to $1.25 cents per share at Wednesday’s closing bell.
In April, 9 Meters raised $31 million by selling some of its stock, The Triangle Business Journal reported. According to its most recent quarterly earnings, the company has around $38.5 million in cash on hand.
While based in Raleigh, the company keeps just a small presence here at an office at 8480 Honeycutt Road, with around 10 employees, including Temperato. It also maintains offices in New York, California and Tel Aviv, Israel.
If it wins approval for any of its pipeline drugs, Temperato said the company would invest heavily in boosting its sales and marketing staff.
This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate