) recently announced that its antibiotic candidate,
solithromycin, showed safety and tolerability in patients ailing
from mild to severe chronic liver diseases. The pharmacokinetic
analyses revealed that no adjustments in dosage were needed for
compensating the decreased liver function in the concerned
This hepatic impairment study was carried out on 24 patients
suffering from chronic liver disease. The patient population was
divided into three sub-categories - 8 with mild disease, 8 with
moderate disease and 8 with severe disease.
The study was based on a 5-day dosage of solithromycin which
included 800 mg on the first day and 400 mg once each day for the
remaining 4 days. The pharmacokinetics of solithromycin was
examined on the selected patient population and compared to the
same dosage regimen given to a matched healthy cohort.
Cempra has an exclusive license and development agreement for
solithromycin with Japanese company, Toyama Chemical Co., Ltd., a
FUJIFILM Holdings Corp.
We note that solithromycin is being developed for the
treatment of community-acquired bacterial pneumonia (CABP) and
gonorrhea. Currently, a phase III trial is evaluating the use of
oral solithromycin in moderate-to-moderately severe CABP.
The company is also planning to initiate an
intravenous-to-oral solithromycin phase III trial in CABP
patients in the fourth quarter of 2013.
Cempra carries a Zacks Rank #2 (Buy). Currently, companies
which look well-positioned include
) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy),
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