CHAPEL HILL, N.C., May 7, 2011 /PRNewswire/ — Cempra
Pharmaceuticals, a developer of differentiated antibiotics, today
announced an oral presentation showing that intravenous (IV) solithromycin
demonstrates excellent tolerability and a favorable pharmacokinetic
(PK) profile at IV doses up to 800 mg. Oral administration of
solithromycin also showed excellent tolerability in previously
reported Phase 1 studies. The presentation will be at the 21st
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID)/27th International Congress of Chemotherapy (ICC), May
7 to 10, 2011, in Milan, Italy. Cempra will also present
additional in vitro activity data on both of the company’s
clinical candidates, solithromycin and TAKSTA (CEM-102
or fusidic acid).
Solithromycin IV Phase 1 Study
The Phase 1 study (Abstract
O-95) was a single-center, randomized, double-blind,
placebo-controlled dose-escalation study in healthy volunteers.
Forty-two subjects were enrolled in the single ascending dose
portion of the study and divided into seven dose cohorts of 25, 50,
100, 200, 400 and 800 mg of solithromycin and placebo.
Subjects were monitored for 48 hours post-dose for safety and
There were no serious adverse events or clinically significant
laboratory abnormalities. The drug candidate demonstrated a
favorable PK profile in single doses up to 800 mg and achieved
clinically relevant plasma concentrations of about 4 micrograms/mL.
Intravenous exposure was 1.3 to three fold higher than that
observed with equivalent oral doses.
“Solithromycin is currently in