Pipeline


  PRODUCT/INDICATION PRE CLINICAL PHASE 1 PHASE 2 PHASE 3
Baxdela (delafloxacin)
Hospital-Treated Skin Infections (ABSSSI)
IV STUDY COMPLETED (SPA) (QIDP)
NDA submitted Oct 2016
Hospital-Treated Skin Infections (ABSSSI)
IV-ORAL STUDY COMPLETED (SPA) (QIDP)
NDA submitted Oct 2016
Hospital-Treated Community-Acquired Bacterial Pneumonia (hCABP)
IV-ORAL (QIDP)
Hospital-Treated Complicated Urinary Tract Infections (cUTI)
IV-ORAL (PURSUING QIDP)
ESKAPE Pathogen Program
Radezolid
Dermatology
PARTNER
Macrolide Program
  • ABSSSI: Acute bacterial skin and skin structure infections || hCABP: Hospital-treated community-acquired bacterial pneumonia || cUTI: Complicated urinary tract infections
    ESKAPE: The ESKAPE pathogen is methicillin-resistant Staphylococcus aureus
    QIDP: Qualified Infectious Disease Product || SPA: Special Protocol Assessment

Melinta Therapeutics’ lead therapy is Baxdela (delafloxacin), which has completed Phase 3 testing for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Melinta submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela in October 2016. The Company has also initiated a Phase 3 clinical trial for hospital-treated community acquired bacterial pneumonia (CABP) and plans to develop further indications such as complicated urinary tract infections (cUTI). Click here to visit the Baxdela webpage to learn more about this investigational therapy.

eskape pathogen program videoOur earlier-stage pipeline includes multiple compounds in preclinical and clinical testing that have been developed to target binding sites on the bacterial ribosome. The ribosome is an essential component of all living cells, including bacteria, and translates genetic information into proteins. Ribosomes are comprised of a small (30S) and large (50S) subunit. Antibiotics work by targeting and binding to sites within either subunit of the bacterial ribosome, inhibiting protein synthesis and killing the bacteria. Our work is based on proprietary knowledge of the structure and function of the bacterial ribosome drawn from high definition X-ray crystallography, for which one of our founders, Dr. Thomas Steitz, was awarded the 2009 Nobel Prize in Chemistry because of the potential of the science to help design better, life-saving antibiotics. Our pipeline includes a family of antimicrobial compounds that were synthesized with a molecular structure specifically designed to bind to a previously untapped region of the ribosome.

More information on these and other early stage product candidates may be found on the ESKAPE Pathogen and Oxazolidinone and Macrolide webpages.