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news.Sequella has successfully filed an investigational new drug (IND) application with the US Food & Drug Administration (FDA) to evaluate SQ109 in patients suffering from Helicobacter pylori-related duodenal ulcers, and can now initiate Phase II studies.
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SQ109 is currently in Phase II clinical study in patients with pulmonary TB and based on the Phase 1 results achieved under its TB IND, Sequella will conduct the Phase 2 clinical studies of SQ109 in duodenal ulcers.
Sequella will conduct the Phase IIA study to evaluate safety, tolerability, and antimicrobial activity of SQ109, at Baylor College of Medicine, Texas, US.
SQ109, which was co-discovered by scientists at Sequella and the National Institute of Allergy and Infectious Diseases (NIAID), has an excellent activity against H pylori and can kill 99.99% of these bacteria, the company said.
Sequella CEO Carol Nacy said they are quite pleased with the clinical development of SQ109 as they progress through phase 2 trials for tuberculosis (TB) and look forward to achieving similar success against H pylori.