Drugs with QIDP Designation – Update 4/8/2015

For the latest QIDP listing, please click HERE


APPC + QIDP copy

Our latest internet search came up with 37 drugs that garnered QIDP status.  They are listed in the Table below (if I missed a compound, please leave a comment!!).  The table is searchable so you should be able to massage the data to your liking.

Let’s break down the numbers:

  • 34 are antibacterials, 2 are antifungals, and 1 is in the ‘other’ category:
    Drug NameCompanyAction SitePhaseAntibiotic Class
    CadazolidActelion PharmaceuticalsGI onlyPhase 3other
    SMT-19969Summit plcGI onlyPhase 2other
    SurotomycinCubist PharmaceuticalsGI onlyPhase 3glycopeptide
    Amikacin InhaleBayerpulmonaryPhase 3aminoglycoside
    Amikacin + fosfomycinCardeas PharmapulmonaryPhase 2combination
    ArikayceInsmed PharmaceuticalspulmonaryPhase 3aminoglycoside
    Ciprofloxacin DPIBayer HealthCarepulmonaryPhase 3quinolone
    AeroVancSavara PharmaceuticalspulmonaryPhase 2glycopeptide
    CiprofloxacinAradigm PharmaceuticalspulmonaryPhase 3quinolone
    Imipenem/cilastatin + MK-7655MercksystemicPhase 2B-lactam / BLI
    FinafloxacinMerLion PharmaceuticalssystemicPhase 2quinolone
    EravacyclineTetraphase PharmaceuticalssystemicPhase 3tetracycline
    DelafloxacinMelinta TherapeuticssystemicPhase 3quinolone
    NemonoxacinTaiGen BiotechnologysystemicPhase 3quinolone
    Ceftazidime + avibactamActavissystemicApproved USB-lactam / BLI
    SolithromycinCempra PharmaceuticalssystemicPhase 3macrolide / ketolide
    BrilacidinCellceutix PharmaceuticalssystemicPhase 2defensin-mimetic
    Meropenem + RPX7009The Medicines CompanysystemicPhase 3B-lactam / BLI
    BC-3781Nabriva TherapeuticssystemicPhase 2pleuromutilin
    AvarofloxacinActavissystemicPhase 2quinolone
    Ceftolozane + tazobactamMercksystemicApproved USB-lactam / BLI
    Fusidic AcidCempra PharmaceuticalssystemicPhase 2fusidic acid
    IsavuconazoleBasilea PharmaceuticasystemicApproved USazole
    NikZValley Fever SolutionssystemicPhase 1other
    SCY-078Scynexis PharmaceuticalssystemicPhase 1other
    WCK-2349Wockhardt PharmaceuticalssystemicPhase 1quinolone
    PlazomicinAchaogensystemicPhase 3aminoglycoside
    AZD-0914AstraZenecasystemicPhase 2quinolone
    OmadacyclineParatek PharmaceuticalssystemicPhase 3tetracycline
    TedizolidCubist PharmaceuticalssystemicApproved USoxazolidinone
    DalbavancinDurata TherapeuticssystemicApproved USglycopeptide
    OritavancinThe Medicines CompanysystemicApproved USglycopeptide
    RadezolidMelinta TherapeuticssystemicPhase 2oxazolidinone
    Deb-1452Debiopharm PharmaceuticalssystemicPhase 2Fabl inhibitor
    WCK-771Wockhardt PharmaceuticalssystemicPhase 1quinolone
    BisEDT Antimicrobial GelMicrobion CorporationtopicalPhase 1other
    NeutrolinCorMedixtopicalPhase 2other
  • The 34 antibacterials are representatives of 13 antibacterial drug classes,there are 9 compounds not currently used in humans: Abx Class
  • \Most antibacterials have a systemic MoA, fewer were for pulmonary, purely GI, or topical use:
    Action Site
  • Most QIDP drugs are currently in Phases 2 and 3 of development, some have already been approved:
    Phase of Dev

Some interesting findings:

  • Combination therapy with a potent BLI is making a come-back. The arrival of avibactam (ceftazidime/avibactam = Avycaz®) and other novel late-stage BLI from Merck and TMC will change our approach to ESBL infections.
  • Surprising the number of quinolones with MRSA activity as their only claim to fame (i.e., differentiation).
  • The 6 pulmonary drugs are inhaled generic antibiotics from well-known drug classes; hence, not truly representing innovation from the antibiotic point-of-view. However, some are addressing novel non-CF indications, like bronchiectasis, NTM infections, and COPD.

I also categorized drugs by degree of differentiation, using the following simple ranking system:

0 = undifferentiated
1 = significant PK   OR   significant microbiologic differentiation
2 = MDR differentiation
3 = new drug class
4 = new drug class and MDR differentiation

Assigning these categories to all QIDP drugs, I came up with this – admittedly subjective – assessment of the antibacterial development landscape:

Differentiation

I will not disclose which drugs specifically were in Category 0, 1, or 2 (nor those in Category 3 or 4).  Suffice it to say that at least 7 (of 24) systemic antibacterials have a significantly differentiated profile and the potential for great innovation addressing significant medical needs.

Not a bad place to be, I’d say.

NOTE: Zavante Therapeutics should be added to the list for ZTI-01 (intravenous fosfomycin disodium), which is being developed for cUTI.

 

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ABBREVIATIONS USED:
BLI        Beta-lactamase inhibitor
COPD   chronic obstructive pulmonary disease
MDR     multi-drug resistant
NTM     non-tuberculous mycobacteria
CF        cystic fibrosis
ESBL    extended spectrum beta-lactamase
TMC     The Medicines Company
MoA     mode of action

 

 

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