Synthetic Biologics Inc (NYSEMKT:SYN) a clinical stage firm focused on advancing therapeutics to shield the gut microbiome while aiming pathogen specific diseases reported positive topline data from the first Phase IIatrial of SYN-004. It is the lead candidate developed to safeguard the gut microbiome from the unplanned effects of certain commonly utilized IV beta-lactam antibiotics for the prevention CDI and AAD.
Topline data from the ten ileostomized subjects who completed the Phase IIa open-label trial showed that SYN-004 degraded residual intravenous ceftriaxone in the chime without affecting the planned count of ceftriaxone in the bloodstream. Assessment of the chyme from the ileostomized subjects suggests that both dosage strengths of drug SYN-004 degrade residual IV ceftriaxone seen in the chyme, validating the action mechanism of SYN-004.
Additionally, both dosage strengths of drug SYN-004 seems to be well tolerated by the subjects in the trial. Overall, the topline report support the hypothesis that Synthetic drug‘SYN-004’ has the potential to reduce residual IV ceftriaxone.
The expert speaks
Jeffrey Riley, the CEO and President of Synthetic Biologics Inc (NYSEMKT:SYN), said that the completion of the First Phase IIa clinical study for SYN-004 is a significant accomplishment for company. This positive report shows the capacity of SYN-004 to safeguard the gut microbiome from the harmful effects of some IV beta-lactam antibiotics. The second Phase IIa clinical study for SYN-004 is under progress to assess the GI antibiotic-degrading impact and the safety of drug in the presence of PPI, esomeprazole, in subjects with functioning ileostomies.
Riley said that they expect to report topline data from the second Phase IIa of drug SYN-004 during 1H2016. They are delighted to report advancement of SYN-oo4 plan as they begin dosing subjects in the study’s Phase IIbproof-of-concept clinical study that is planned to assess the effectiveness of drug.