{"id":269,"date":"2014-06-16T04:34:04","date_gmt":"2014-06-16T04:34:04","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=269"},"modified":"2014-09-25T12:20:03","modified_gmt":"2014-09-25T16:20:03","slug":"the-antibiotic-pipeline-how-new-is-new","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/06\/16\/269\/the-antibiotic-pipeline-how-new-is-new\/","title":{"rendered":"The Antibiotic Pipeline: How \u201cNew\u201d is New"},"content":{"rendered":"

In a recent \u2018Viewpoint\u2019 article, Dr. Fauci, Director of NIAID,\u00a0<\/span>mentioned that “industry has expanded the pipeline of new antibacterial drugs…with 14-agents currently in phase 3 clinical trials”.[1]<\/p>\n

Regarding the number of drugs in late development, his statement may be correct but many of these drugs are anything but new.\u00a0 Reviewing information from various public sources, [2] [3], there are no antibacterials with a novel mode of action (MoA) in Phase 3 development.<\/p>\n

In development are: \u00a0new combination B-lactam\/B-lactamase inhibitors, modified quinolones, glycopeptides, tetracyclines and oxazolidinones.\u00a0\u00a0 Based on recent tallies\u00a0of the antibacterial pipeline, subtracting\u00a0drugs for topical use, for inhalation or for C. difficile infection, here\u00a0the status:<\/p>\n

PHASE 3 \u00a0 \u00a0 \u00a0 \u00a0Status: 6\/15\/2014
\n<\/strong>PLEASE BE PATIENT – THIS WILL BE UPDATED SHORTLY
\n<\/strong><\/span>\u00a0[table \u201c6\u201d not found \/]
\n<\/p>\n

All in all, there are 10 drugs from well-known drug classes.\u00a0 With ceftobiprole\u2019s fate somewhat uncertain in the US, and oritavancin and tedizolid expected to gain approval shortly, we are left with seven (7) late-stage candidates.\u00a0 They promise to bring small incremental benefits, but benefits nonetheless.\u00a0 History has shown that progress in this area often comes in small steps.\u00a0 Certainly, the extended activity B-lactam + BL-inhibitors will prove useful in places where ESBL and MDR pathogens have become resistant to penems antibiotics.<\/p>\n

The\u00a0Phase 2 pipeline is quite a bit\u00a0more interesting.\u00a0 In addition to existing drug classes, there are\u00a0also pleuromutilins, defensins, Fabl- and PDF inhibitors.<\/p>\n

PHASE 2 \u00a0 \u00a0 \u00a0 \u00a0Status: 6\/15\/2014
\nPLEASE BE PATIENT – THIS WILL BE UPDATED SHORTLY<\/span>
\n<\/strong>\u00a0[table \u201c5\u201d not found \/]
\n<\/p>\n

The pleuromutilin class of drugs are already widely used in veterinary medicine and considered safe for animals.\u00a0 Nonetheless, more data confirming\u00a0safety in humans is needed.<\/p>\n

PDF inhibitors have a checkered history as resistance develops rather fast. \u00a0There are also concerns about toxicities. \u00a0Likewise, quinolones had problems with rapid development of MRSA resistance in the clinic. Presumably, the preclinical data packages\u00a0are addressing these\u00a0issues and\u00a0support development of\u00a0both drug classes.<\/p>\n

————————————————————————————-<\/p>\n

References<\/strong><\/p>\n

[1] A. Fauci.\u00a0 JAMA 2014; 311: 1853
\n[2] http:\/\/www.pewhealth.org\/other-resource\/antibiotics-currently-in-clinical-development-85899541594
\n<\/a>[3] M. Pucci\u00a0 Microbe 2014; 9: 147<\/p>\n","protected":false},"excerpt":{"rendered":"

In a recent \u2018Viewpoint\u2019 article, Dr. Fauci, Director of NIAID,\u00a0mentioned that “industry has expanded the pipeline of new antibacterial drugs…with 14-agents currently in phase 3 clinical trials”.[1] Regarding the number of drugs in late development, his statement may be correct but many of these drugs are anything but new.\u00a0 Reviewing Continue reading The Antibiotic Pipeline: How \u201cNew\u201d is New<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":899,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[18],"tags":[112,114,70,83,116,113,67,254,115,111,102,110,117,535,7,263],"class_list":["post-269","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the_viewpoint","tag-antibiotic-development","tag-ceftobiprole","tag-glycopeptide","tag-mrsa","tag-mrsa-quinolones","tag-novel-mode-of-action","tag-oritavancin","tag-oxazolidinone","tag-pdf-inhibitor","tag-phase-2","tag-phase-3","tag-pipeline","tag-pleuromutilin","tag-quinolone","tag-tedizolid","tag-tetracycline"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/new-3-pipelines.jpg?fit=640%2C200&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-4l","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1332,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/28\/1332\/drugs-with-qidp-designation-update-3282015\/","url_meta":{"origin":269,"position":0},"title":"Drugs with QIDP Designation \u2013 Update 4\/8\/2015","author":"Harald","date":"March 28, 2015","format":false,"excerpt":"For the latest QIDP listing, please click HERE Our latest internet search came up with 37 drugs that garnered QIDP status.\u00a0 They are listed in the Table below (if I missed a compound, please leave a comment!!). \u00a0The\u00a0table is searchable so you should be able to massage the data to\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"APPC + QIDP copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/10\/APPC-QIDP-copy.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":3211,"url":"https:\/\/allphasepharma.com\/dir\/2017\/03\/05\/3211\/qidp-liberal-hand-out-fda\/","url_meta":{"origin":269,"position":1},"title":"QIDP, a Liberal Hand-Out from FDA","author":"Harald","date":"March 5, 2017","format":false,"excerpt":"On our blog site, \u2018QIDP\u2019 stands for \u201cQualified Infectious Diseases Product\u201d but when you look up \u2018QIDP\u2019 on the internet, you will find that it also stands for \u201cQualified Intellectual Disabilities Professional\u201d. Looking at the more recent crop of ID products that garnered QIDP status, you wonder whether there is\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2289,"url":"https:\/\/allphasepharma.com\/dir\/2016\/02\/10\/2289\/the-10-x-20-goal-are-we-on-track\/","url_meta":{"origin":269,"position":2},"title":"The 10 x \u201920 Goal \u2013 Are We On Track?","author":"Harald","date":"February 10, 2016","format":false,"excerpt":"In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to oncology projects which had a much better ROI. 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