QIDP Antibiotics – 2015 Year-End Update

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Here an updated listing of all QIDP drugs we are aware of as of 12/24/2015. Today just facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs.

There are 58 drugs which garnered QIDP status and these are listed in the Main Table below. With the recent approval of 6 of them (isavuconazole / Cresemba, tedizolid / Sivextro, dalbavancin / Dalvance, oritavancin / Orbactiv, ceftolozane/tazobactam / Zerbaxa, and ceftazidime/avibactam / Avycaz), 52 antibiotics are at various stages of development.  As the 6 approved QIDP antibiotics were discussed at this site in some detail before, all that needs to be said about them is: Congratulations!

Main Table

CompanyDrug NameAction SitePhase
Savara PharmaceuticalsAeroVancpulmonaryPhase 2
Cardeas PharmaAmikacin + fosfomycinpulmonaryPhase 2
BayerAmikacin InhalepulmonaryPhase 3
Insmed PharmaceuticalsArikaycepulmonaryPhase 3
AllerganAvarofloxacinsystemicPhase 2
Nabriva TherapeuticsBC-3781systemicPhase 3
Microbion CorporationBisEDT Antimicrobial GeltopicalPhase 1
Cellceutix PharmaceuticalsBrilacidinsystemicPhase 2
Actelion PharmaceuticalsCadazolidGI onlyPhase 3
AllerganCeftazidime + avibactamsystemicApproved US
Basilea PharmaceuticaCeftobiprolesystemicPhase 3
MerckCeftolozane + tazobactamsystemicApproved US
Aradigm PharmaceuticalsCiprofloxacinpulmonaryPhase 3
Bayer HealthCareCiprofloxacin DPIpulmonaryPhase 3
Innocoll AGCogenziatopicalPhase 3
Durata TherapeuticsDalbavancinsystemicApproved US
Debiopharm PharmaceuticalsDebio-1450systemicPhase 2
Debiopharm PharmaceuticalsDebio-1452systemicPhase 2
Melinta TherapeuticsDelafloxacinsystemicPhase 3
Tetraphase PharmaceuticalsEravacyclinesystemicPhase 3
EntasisETX-0914systemicPhase 2
MerLion PharmaceuticalsFinafloxacinsystemicPhase 2
Cempra PharmaceuticalsFusidic AcidsystemicPhase 3
GlaxoSmithKline plcGSK-2140944systemicPhase 2
Motif BioIclaprimsystemicPhase 3
Merck & Co., Inc.Imipenem/cilastatin + MK-7655systemicPhase 3
Basilea PharmaceuticaisavuconazolesystemicApproved US
Ixodes AGIxogeltopicalPhase 2
Matinas BioPharmaMAT-2203systemicPhase 2
Matinas BioPharmaMAT-2501systemicPre-Clin
Meiji Seika PharmaME-1100pulmonaryPhase 1
The Medicines CompanyMeropenem + RPX7009systemicPhase 3
Leonard Meron BiosciencesMino-LoktopicalPhase 2
TaiGen BiotechnologyNemonoxacinsystemicPhase 3
CorMedixNeutrolintopicalPhase 2
Valley Fever SolutionsNikZsystemicPhase 1
Paratek PharmaceuticalsOmadacyclinesystemicPhase 3
The Medicines CompanyOritavancinsystemicApproved US
AchaogenPlazomicinsystemicPhase 3
PolyphorPOL-7080systemicPhase 2
Melinta TherapeuticsRadezolidsystemicPhase 2
RedHill BiopharmaRHB-105systemicPhase 3
Scynexis PharmaceuticalsSCY-078systemicPhase 2
Summit plcSMT-19969GI onlyPhase 2
Cempra PharmaceuticalsSolithromycinsystemicPhase 3
MerckSurotomycinGI onlyPhase 3
Symbiomix TherapeuticsSYM-1219systemicPhase 3
Cubist PharmaceuticalsTedizolidsystemicApproved US
TetraphaseTP-271systemicPre-Clin
VicalVL-2397systemicPre-Clin
Viamet PharmaceuticalsVT-1129systemicPhase 1
Wockhardt PharmaceuticalsWCK-2349systemicPhase 1
WockhardtWCK-4873systemicPhase 1
WockhardtWCK-5222systemicPhase 1
Wockhardt PharmaceuticalsWCK-771systemicPhase 1
Wockhardt PharmaceuticalsWCK-771systemicPhase 2
Destiny PharmaXF-73topicalPhase 2
Zavante Therapeutics, Inc.ZTI-01systemicPhase 1

Of the QIDP antibiotics still in preclinical or clinical development (N=52), 6 are systemically active antifungals. Other than 2 azoles and 1 amphotericin reformulation, 3 agents seem to have a new MoA: Vical’s ASP-2397, the nikkomycin from Valley Fever Solutions, and the enfumafungin SCY-078 developed by Scynexis.

Moving on to the core group of QIDP antibacterials (N=46), 30 are systemically active, 7 are for pulmonary administration, 6 for topical application, and 3 are enterically targeted CDI drugs.

by phase

The group of pulmonary QIDP drugs (N=7) is targeting the usual respiratory problem pathogens, i.e., S. aureus, Pseudomonas, and Gram-negatives.  The indications pursued include not only CF, but also NTM, bronchiectasis and VABP (as adjunctive therapy), and even combinations of drugs are studied for aerosol delivery.  None of the antibiotics come from new drug classes.

Most QIDP antibacterials have a systemic MoA (N=30), and most are also from established classes.  The fluoroquinolones still predominate, but some old drugs are back; importantly, a few novel drugs have made the list:

  • a topoisomerase II inhibitor (ETX-0914) in development for GC only
  • FabI inhibitors (like Debio-1450 and 1452) pursuing skin infection indications
  • a pleuromutilin (BC-3781) in development for skin infection and CABP
  • a defensin-mimetic (PMX-30063) in development for ABSSSI

by Abx

It is notable that many systemic antibiotics have advanced to later development phases since the last QIDP review here.

Your comments and feedback are always appreciated.

Abbreviations:
GC      gonococcal infection
CF      cystic fibrosis
NTM    non-tuberculous mycobacteria
ABSSSI   skin infection
CABP      community acquired bacterial pneumonia
MoA    mode of action
CDI     C. difficile infection

 

 

 

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