Solithromycin

  PRODUCT/INDICATION PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Submitted FDA Approved
Community acquired bacterial pneumonia (CABP)
Oral (QIDP)
IV-to-oral (QIDP)
Pediatric (QIDP)
Urethritis / gonorrhea
Oral
Conjunctivitis / blepharitis /dry eye
Ophthalmic
PRODUCT/INDICATION DELIVERY/PHASE
Solithromycin
Community acquired bacterial pneumonia (CABP)
Oral (QIDP) / NDA Submitted
IV-to-oral (QIDP) / NDA Submitted
Pediatric (QIDP) / Phase 3
Urethritis / gonorrhea
Oral / Phase 3
Conjunctivitis / blepharitis /dry eye
Ophthalmic / Preclinical

Solithromycin is a next-generation oral and intravenous macrolide, which has potent activity against most macrolide-resistant CABP pathogens. Solithromycin completed two Phase 3 clinical trials testing both oral and IV formulations for the treatment of CABP and new drug applications, or NDAs, were submitted to the FDA in April 2016. In December 2016, Melinta received a complete response letter, or CRL, from the FDA on both NDAs that agreed solithromycin efficacy had been demonstrated, but that required additional safety data as well as resolution of certain manufacturing concerns as a condition for response. Melinta is actively engaged with potential government and industry partners to identify non-dilutive funding to support the execution of this study.

Solithromycin is also being formulated for ophthalmic indications to support a potential Investigational New Drug, or IND, application filing in 2018. In the second quarter, Melinta presented data at the annual meeting of the Association for Research in Vision and Ophthalmology highlighting topical ophthalmic formulations of solithromycin in preclinical models of activity, tolerability and pharmacokinetics in the eye. Melinta anticipates exploring the potential effects of solithromycin to treat ophthalmic bacterial infections as well as dry eye.