{"id":2205,"date":"2015-12-23T14:33:44","date_gmt":"2015-12-23T19:33:44","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2205"},"modified":"2016-03-23T04:39:08","modified_gmt":"2016-03-23T08:39:08","slug":"qidp-antibiotics-2015-year-end-update","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/12\/23\/2205\/qidp-antibiotics-2015-year-end-update\/","title":{"rendered":"QIDP Antibiotics – 2015 Year-End Update"},"content":{"rendered":"

\"QIDP<\/a><\/p>\n

Here an updated listing of all QIDP drugs we are aware of as of 12\/24\/2015. Today just\u00a0facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs.<\/p>\n

There are\u00a058 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.\u00a0 As the 6\u00a0approved QIDP antibiotics were discussed at this site in some detail before, all that needs to be said about them is: Congratulations!<\/p>\n

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

Of the QIDP antibiotics still in preclinical or clinical development (N=52), 6 are systemically active antifungals. Other than\u00a02 azoles and 1 amphotericin reformulation, 3 agents seem to have a new MoA: Vical\u2019s ASP-2397, the nikkomycin from Valley Fever Solutions, and the enfumafungin SCY-078 developed by Scynexis.<\/p>\n

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.<\/p>\n

\"by<\/a><\/p>\n

The group of pulmonary QIDP drugs (N=7) is targeting the usual respiratory problem pathogens, i.e.,\u00a0S. aureus, Pseudomonas, and Gram-negatives.\u00a0 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.\u00a0 None of the antibiotics come from new drug classes.<\/p>\n

Most QIDP antibacterials have a systemic MoA (N=30), and most are also from established classes.\u00a0 The fluoroquinolones\u00a0still predominate, but some old drugs are back; importantly, a few novel drugs have made the list:<\/p>\n