Data on Cempra's Solithromycin
Cempra, Inc. (CEMP) 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 patient population.
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 subsidiary of FUJIFILM Holdings Corp. (FUJIY).
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 Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy), respectively.
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