Sequella files SQ109 IND for Phase 2 studies in H. pylori-related duodenal ulcers

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of infectious diseases, announced it has successfully filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) to test SQ109 in patients suffering from H. pylori-related duodenal ulcers, and can now begin Phase 2 studies.

“H. pylori is an important human pathogen and the cause of gastric cancer. Worldwide, increasing antibiotic resistance has resulted in a marked reduction in the ability to cure the infection, and new drugs are urgently needed”

"H. pylori is a highly infectious pathogen that causes 95% of duodenal and 85% of gastric ulcers, and is implicated in most gastric cancers," said Dr. Carol A. Nacy, CEO of Sequella. "We are quite pleased with the clinical development of SQ109 as we progress through phase 2 trials for tuberculosis (TB) and look forward to achieving similar success against H. pylori."

SQ109 is currently in Phase 2 clinical assessment in patients with pulmonary TB. Based on Phase 1 results achieved under its TB IND, SQ109 will directly begin Phase 2 clinical studies in duodenal ulcers. Data from the laboratory of D. Scott Merrell at the Uniformed Services University of the Health Sciences, Bethesda, Maryland show both significant SQ109 antimicrobial activity against H. pylori and therapeutic potential.

In collaboration with Dr. David Y. Graham, a world expert in H. pylori, Sequella will conduct a phase 2A study to evaluate the safety, tolerability, and antimicrobial activity of SQ109 at the Baylor College of Medicine, Houston, Texas. "H. pylori is an important human pathogen and the cause of gastric cancer. Worldwide, increasing antibiotic resistance has resulted in a marked reduction in the ability to cure the infection, and new drugs are urgently needed," stated Dr. Graham.

According to the National Institutes of Health, approximately 14.5 million people in the United States are thought to suffer from ulcers. A new drug that simplifies the current 3-4 drug treatment regimen could result in a potential annual US market of more than $500 million.