Date: 2016-12-05
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
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.
- Toyama owns exclusive rights to develop and commercialize solithromycin in Japan for respiratory tract infections and other indications in adults and pediatric patients.
In November 2016 , Cempra announced it had received a $10 million milestone payment when Toyama decided to progress to Phase 3 studies. Cempra has received $40 million of upfront and milestone payments from Toyama and can earn an additional $30 million , for a total of $70 million , in payments from Toyama based on the achievement of certain objectives. If approved, Toyama would pay tiered royalties, adjusted based on sales, to Cempra following launch of solithromycin in Japan .
Disease: community-acquired bacterial pneumonia (CABP)
Therapeutic
area: Infectious diseases
Country: Japan
Trial
details:
Latest
news:
- • On December 5, 2016, Cempra announced that Toyama Chemical has begun Phase 3 clinical trials with solithromycin in Japan for patients with community-acquired bacterial pneumonia (CABP) and other respiratory infections.
- Earlier in 2016, Toyama completed a Phase 2 multi-center, randomized, double-blinded study of 135 Japanese patients with mild to moderate CABP . Patients were randomized to either oral solithromycin or oral levofloxacin for five days. Overall safety and tolerability was similar in both treatment groups and all efficacy outcome measures favored solithromycin. These data, and the data from Cempra's studies, were reviewed by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) before finalizing the Phase 3 study protocol.
Is
general: Yes
