Date: 2016-05-25
Type of
information: Results
phase: 2
Announcement: results
Company: Cempra (USA - NC) Toyama Chemical (Japan)
Product: solithromycin
Action
mechanism:
- antibiotic/macrolide. Solithromycin is a next-generation oral and intravenous fluoroketolide now in Phase 3 clinical development for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP) and urethritis. In vitro and in vivo studies have shown potent activity against S. pneumoniae as well as an extended spectrum of activity against CA-MRSA, enterococci, Mycobacterium avium and in animal models of malaria. It is also active against atypical bacteria, such as Legionella, Chlamydophila, Chlamydia, Mycoplasma and Ureaplasma and against gonococci and other organisms that cause genitourinary tract infections. It is 8-16 times more potent than azithromycin and is active against azithromycin-resistant strains. Its activity against resistant strains is driven by its ability to bind to three sites on the bacterial ribosome, compared to one or two for current macrolides. The binding to three ribosomal sites is expected to limit resistance development.
- Solithromycin does not contain a pyridine in the side chain of the molecule (as does telithromycin or Ketek®) that appears to interact with nicotinic acetylcholine receptors and could be associated with serious adverse events such as visual disturbances and exacerbations of myasthenia gravis that have been observed with telithromycin.
Disease: mild to moderate community-acquired pneumonia (CABP)
Therapeutic
area: Infectious diseases
Country: Japan
Trial
details:
Latest
news:
- • On May 25, 2016, Cempra announced that its partner for the Japanese market, Toyama Chemical , a subsidiary of FUJIFILM Holdings, has conducted a phase 2, multi-center, randomized, double-blind study to evaluate the efficacy, safety and pharmacokinetics of solithromycin in Japanese patients. Patients with mild to moderate community-acquired pneumonia were randomized at a 2:1 ratio to either oral solithromycin or oral levofloxacin for 5 days. Solithromycin recipients received 800 mg on the first day, either as a single dose (QD group), or as a divided dose (BID group), and 400 mg daily on Days 2-5. Levofloxacin recipients received 500 mg once daily on Days 1-5. The Japanese study was similar in design to the Phase 3 studies conducted by Cempra in CABP in accordance with guidance from the FDA and the European Medicines Agency (EMA).
Efficacy: Among 154 enrolled and randomized patients, 135 received at least one dose of study medication, and were confirmed by independent expert physician review to have CABP (the modified ITT population). In the modified ITT population, Test of Cure visit (5-10 days after completion of therapy) success was achieved in 34/44 (77.3%), 32/44 (72.7%), and 29/47 (61.7%) patients in the solithromycin QD and BID and Levofloxacin groups, respectively. In the pre-specified Per Protocol population comprised of those patients meeting key study inclusion and exclusion criteria, success at the Test of Cure visit was achieved in 34/40 (85.0%) in the solithromycin QD group, versus 31/40 (77.5%) in the solithromycin BID group, and 29/43 (67.4%) in the levofloxacin group.
Safety: Overall safety and tolerability was similar in both treatment groups, including hepatic events such as increases in alanine aminotransferase (ALT).
Is
general: Yes
