Patent Issued for 9 Meters Biopharma’s Potential COVID-19 Treatment
Thinking outside the gut, a Raleigh pharmaceutical upstart is landing support for exploring its tissue-tweaking technology as a possible extension from gastrointestinal disorders to lung problems.
That’s why 9 Meters Biopharma has secured patent protection for its potential approach to treating lung disease.
The U.S. Patent and Trademark Office issued U.S. Pat. No. 10,723,763, titled, “Use of Tight Junction Antagonists in the Treatment of Acute Lung Injury and Acute Respiratory Distress,” relating to larazotide, the company’s proprietary investigational agent.
The patent issuance “validates the unique mechanistic profile of our novel first-in-class tight junction modulator,” said John Temperato, president and chief executive officer of 9 Meters. "This patent, along with the vast pre-clinical and clinical data that has characterized larazotide, highlights the importance of normalizing leaky tight junctions in disparate disease states.”
Tight junctions are protein bands that seal the space between epithelial cells, limiting the passage of molecules and ions between cells. The disruption of tight junctions in the gastrointestinal tract causes “leaky gut,” a condition linked to multiple auto-immune diseases including celiac disease, irritable bowel syndrome, Crohn’s disease, ulcerative colitis and other disorders.
Larazotide is an oral peptide that decreases intestinal permeability and regulates tight junctions by reducing antigen trafficking across epithelial cells.
The compound is currently in Phase 3 development to treat celiac disease, a disorder caused by an inflammatory response to gluten, a group of proteins found in cereal grains.
‘Broader potential utility’
Studies suggest larazotide may have additional uses well beyond celiac disease.
“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," Temperato said.
The granted 9 Meters patent shows that larazotide restores normal permeability of pulmonary tissue containing cellular tight junctions, and treats the direct cause of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), two disorders that can cause fluid buildup in the lungs.
In pre-clinical models, larazotide has been shown to improve ALI as measured by protein, cellular and inflammatory markers. The compound may also have a protective effect in virally challenged mice during infection, mitigating ALI by reducing excess fluid in the lungs.
Emerging data suggest larazotide may even be a potential drug candidate for targeting the main protease in SARS-CoV-2, the virus responsible for the COVID-19 pandemic.
9 Meters said it’s “evaluating potential next steps” for researching the compound’s impact on ALI and ARDS associated with COVID-19. The development work could be done internally or by another company under a license agreement, the company said.
Company born of recent merger
9 Meters was formed in late 2019 by the merger of Innovate Biopharmaceuticals of Raleigh and RDD Pharma of Tel Aviv, Israel. The combined company, renamed 9 Meters Biopharma, is focused on rare and unmet needs in gastroenterology.
In addition to larazotide, 9 Meters is developing NM-002, a proprietary long-acting glucagon-like peptide-1 agonist for treating short bowel syndrome. A Phase 1b/2a study began dosing its first patients in July.
9 Meters’ stock shares are traded on the Nasdaq stock exchange under the ticker symbol NMTR.