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
| Company | Drug Name | Action Site | Phase |
|---|---|---|---|
| Savara Pharmaceuticals | AeroVanc | pulmonary | Phase 2 |
| Cardeas Pharma | Amikacin + fosfomycin | pulmonary | Phase 2 |
| Bayer | Amikacin Inhale | pulmonary | Phase 3 |
| Insmed Pharmaceuticals | Arikayce | pulmonary | Phase 3 |
| Allergan | Avarofloxacin | systemic | Phase 2 |
| Nabriva Therapeutics | BC-3781 | systemic | Phase 3 |
| Microbion Corporation | BisEDT Antimicrobial Gel | topical | Phase 1 |
| Cellceutix Pharmaceuticals | Brilacidin | systemic | Phase 2 |
| Actelion Pharmaceuticals | Cadazolid | GI only | Phase 3 |
| Allergan | Ceftazidime + avibactam | systemic | Approved US |
| Basilea Pharmaceutica | Ceftobiprole | systemic | Phase 3 |
| Merck | Ceftolozane + tazobactam | systemic | Approved US |
| Aradigm Pharmaceuticals | Ciprofloxacin | pulmonary | Phase 3 |
| Bayer HealthCare | Ciprofloxacin DPI | pulmonary | Phase 3 |
| Innocoll AG | Cogenzia | topical | Phase 3 |
| Durata Therapeutics | Dalbavancin | systemic | Approved US |
| Debiopharm Pharmaceuticals | Debio-1450 | systemic | Phase 2 |
| Debiopharm Pharmaceuticals | Debio-1452 | systemic | Phase 2 |
| Melinta Therapeutics | Delafloxacin | systemic | Phase 3 |
| Tetraphase Pharmaceuticals | Eravacycline | systemic | Phase 3 |
| Entasis | ETX-0914 | systemic | Phase 2 |
| MerLion Pharmaceuticals | Finafloxacin | systemic | Phase 2 |
| Cempra Pharmaceuticals | Fusidic Acid | systemic | Phase 3 |
| GlaxoSmithKline plc | GSK-2140944 | systemic | Phase 2 |
| Motif Bio | Iclaprim | systemic | Phase 3 |
| Merck & Co., Inc. | Imipenem/cilastatin + MK-7655 | systemic | Phase 3 |
| Basilea Pharmaceutica | isavuconazole | systemic | Approved US |
| Ixodes AG | Ixogel | topical | Phase 2 |
| Matinas BioPharma | MAT-2203 | systemic | Phase 2 |
| Matinas BioPharma | MAT-2501 | systemic | Pre-Clin |
| Meiji Seika Pharma | ME-1100 | pulmonary | Phase 1 |
| The Medicines Company | Meropenem + RPX7009 | systemic | Phase 3 |
| Leonard Meron Biosciences | Mino-Lok | topical | Phase 2 |
| TaiGen Biotechnology | Nemonoxacin | systemic | Phase 3 |
| CorMedix | Neutrolin | topical | Phase 2 |
| Valley Fever Solutions | NikZ | systemic | Phase 1 |
| Paratek Pharmaceuticals | Omadacycline | systemic | Phase 3 |
| The Medicines Company | Oritavancin | systemic | Approved US |
| Achaogen | Plazomicin | systemic | Phase 3 |
| Polyphor | POL-7080 | systemic | Phase 2 |
| Melinta Therapeutics | Radezolid | systemic | Phase 2 |
| RedHill Biopharma | RHB-105 | systemic | Phase 3 |
| Scynexis Pharmaceuticals | SCY-078 | systemic | Phase 2 |
| Summit plc | SMT-19969 | GI only | Phase 2 |
| Cempra Pharmaceuticals | Solithromycin | systemic | Phase 3 |
| Merck | Surotomycin | GI only | Phase 3 |
| Symbiomix Therapeutics | SYM-1219 | systemic | Phase 3 |
| Cubist Pharmaceuticals | Tedizolid | systemic | Approved US |
| Tetraphase | TP-271 | systemic | Pre-Clin |
| Vical | VL-2397 | systemic | Pre-Clin |
| Viamet Pharmaceuticals | VT-1129 | systemic | Phase 1 |
| Wockhardt Pharmaceuticals | WCK-2349 | systemic | Phase 1 |
| Wockhardt | WCK-4873 | systemic | Phase 1 |
| Wockhardt | WCK-5222 | systemic | Phase 1 |
| Wockhardt Pharmaceuticals | WCK-771 | systemic | Phase 1 |
| Wockhardt Pharmaceuticals | WCK-771 | systemic | Phase 2 |
| Destiny Pharma | XF-73 | topical | Phase 2 |
| Zavante Therapeutics, Inc. | ZTI-01 | systemic | Phase 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.
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
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
