Celiac disease drug and implications for lung injury and respiratory distress in COVID-19

The company studying a drug to address leaky gut in celiac disease has received a patent for investigation of the drug’s effectiveness in treating lung disease, including potentially when it occurs in COVID-19.

9 Meters Biopharma is currently studying larazotide acetate in celiac disease in a Phase 3 clinical trial, the furthest any celiac disease treatment has gotten.

“The patent along with the vast pre-clinical and clinical data that has characterized larazotide, highlight the importance of normalizing leaky tight junctions in disparate disease states,” John Temperato, president and CEO of 9 Meters, said in a press release. “Given the potential clinical impact that may result from normalizing tight junctions in disorders beyond larazotide’s main target of celiac disease, we are allowing the exploration of the compound’s broader potential utility in certain cases.”

The 9 Meters’ patent shows  larazotide re-normalizes abnormally increased permeability of lung tissue containing cellular tight junction, and treats the direct cause of [acute lung injury] and [acute respiratory distress syndrome] which can lead to fluid buildup within affected areas of the lungs, according to the company. 9 Meters said it is evaluating potential next steps for researching the compound’s impact on acute lung conditions associated with COVID-19.

In celiac disease, larazotide acetate is designed to tighten junctions between intestinal cells, the so-called leaky gut that occurs in celiac disease. Leaky gut is thought to be the gateway to many autoimmune diseases, including celiac disease. The drug would help restore the leaky junctions to a normal state and would be used in addition to the gluten-free diet.

Temperato describes larazotide acetate as working “a bit like shoelaces” to tighten the junctions between cells. 9 Meters expects larazotide to be prescribed alongside a gluten-free diet.

The celiac disease clinical trial is evaluating the drug for patients with celiac disease who continue to experience gastrointestinal symptoms while following a gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants who are on a gluten-free diet but have ongoing abdominal symptoms. Researchers will measure changes in patient reported outcomes related to symptoms over 12 weeks, comparing two dose amounts of larazotide acetate to a placebo. Recruitment is ongoing, and results are expected by the end of 2021.

Innovate Biopharmaceuticals was developing larazotide acetate before merging with RDD Pharma and to from 9 Meters.