Seres Therapeutics to Initiate New SER-109 Clinical Study
– Positive SER-109 Type B FDA meeting –
– Seres and FDA reach agreement on key design elements of a new SER-109 Phase 2 study in patients with multiply recurrent C. difficile infection –
– New trial may qualify as a Pivotal Study with achievement of a persuasive clinical effect and addressing FDA requirements –
– Conference call at 8 a.m. ET today –
Seres Therapeutics Inc., (NASDAQ:MCRB), a leading microbiome therapeutics platform company, today announced plans to initiate a new SER-109 Phase 2 clinical study (ECOSPOR III) in patients with multiply recurrent Clostridium difficile (C. difficile) infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the U.S. Food and Drug Administration (FDA). In a separate announcement today, Seres reported fourth quarter and full year 2016 financial results and provided an update on multiple ongoing microbiome clinical programs.
- Published: 16 March 2017
- Written by Editor