Synthetic Biologics Inc (NYSEMKT:SYN) shares rose in Monday’s pre-market session after the biotechnology company reported encouraging top-line safety and tolerability results Monday from a Phase 1a clinical trial of SYN-004, its oral beta-lactamase enzyme for the prevention of C. difficile infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving IV beta-lactam antibiotic therapy.
Shares of Synthetic Biologics Inc (SYN) were up 4% at $1.58 in recent pre-market trading, within a 52-week range of $1.09 to $3.64.
The Phase 1a clinical trial enrolled 24 healthy volunteers in three cohorts of eight patients each. It said a total of 18 volunteers have been administered one dose of SYN-004 at increasing dose levels by cohort, and six volunteers received placebo. No clinically significant or relevant adverse events have been reported to date.
“Based on the results observed in the first three cohorts, and per our clinical plan, we intend to proceed with our planned multiple-ascending dose placebo-controlled Phase 1b study of SYN-004, in which healthy volunteers will receive increasing doses of SYN-004 over several days,” said CEO Jeffrey Riley. “We expect enrollment into our Phase 1b SYN-004 clinical trial to begin before year-end, with top-line data available during the first quarter of 2015. We also expect to initiate enrollment in a Phase 2 SYN-004 clinical trial.”