{"id":2817,"date":"2016-10-24T04:29:19","date_gmt":"2016-10-24T08:29:19","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2817"},"modified":"2025-09-20T19:19:01","modified_gmt":"2025-09-21T01:19:01","slug":"qidp-drug-update-part-2-categories-of-interest","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2016\/10\/24\/2817\/qidp-drug-update-part-2-categories-of-interest\/","title":{"rendered":"QIDP Drug Update \u2013 Part 2: \u00a0Categories of Interest"},"content":{"rendered":"

\"qidp-part2-slider\"<\/a><\/p>\n

According to Janet Woodcock, 63 drugs have been given the \u201cQIDP\u201d designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development.\u00a0 So we are in fairly close agreement.<\/p>\n

That may seem like an impressive record but it is also a bit misleading: There were few new applicants in 2016 and the numbers are plateauing.<\/p>\n

But QIDP drugs are just the tip of the iceberg, right? \u00a0Well, it happens to be a rather small iceberg floating around. Certainly, there are many more antibiotics in development without\u00a0QIDP status. Some companies choose to wait before applying for QIDP designation or have strategic and financial reasons to postpone the application. Others, also for mostly strategic or publicity reasons, ask for QIDP designation already at the research stage.<\/p>\n

Let\u2019s spend some time looking at the\u00a0larger groupings in the QIDP registry.<\/p>\n

#1: ALL THESE AEROSOLS \u2013 NOT ONLY FOR CF<\/strong>
\nFDA makes it easy to garner the QIDP label and the Agency has been most generous to applicants. Too generous, perhaps.\u00a0 QIDP status and benefits were handed out to some drugs that are nothing more than reformulations of old antibiotics. Aerosols lead that list, as every drug class seems to lend itself for aerosol delivery. Of note, they are no longer developed just for lung infection in CF patients but also for non-CF conditions like chronic bronchiectasis, as adjuncts to systemic antibiotics for VAPB prophylaxis and treatment, and for the treatment or suppression of NTM lung disease. These are\u00a0innovative approaches and makes these drugs more than “TOBI mimetics”.<\/p>\n

#2: MORE BL\/BLI COMBINATIONS TO COME \u2013 BRING \u2018EM ON<\/strong>
\nThere is a strong effort underway to develop new BL\/BLI combinations. CTAZ plus avibactam was just approved (Avycaz), but avibactam can be combined with other BLs as well. The combination with aztreonam makes a lot of sense, the combination with ceftaroline not so much to this reviewer; both combinations are at an advance stages of development.<\/p>\n

Several newer BLI may widen the coverage against\u00a0MDR pathogens compared to\u00a0Avycaz. These drugs have small but hopefully important differences in activity against MDR pathogens and Acinetobacter, thus justifying a separate\u00a0development effort.<\/p>\n

From a marketing perspective, the goal may not be to achieve\u00a0super-activity against all kinds of MDR pathogens but rather \u2018mediocrity in excellence\u2019: Companies may prefer to develop a successor to Piperacillin\/Tazobactam (Zosyn) and become the new \u2018workhorse BL\/BLI\u201d rather than cover all classes of beta-lactamases, from A to Z (or D in this case).<\/p>\n

Clearly, there are significant hurdles for BL\/BLI combos, not just from the scientific perspective. Their commercial potential is hard to predict and the regulatory path to approval may be tougher than it was for Avycaz.<\/p>\n

NDM pathogens are not covered by the current crop of BL\/BLI inhibitors and it will be important to close this gap.<\/p>\n

Could a BLI be developed as a stand-alone inhibitor, to be freely combined with any number of BLs?\u00a0 It sounds intriguing but there are significant regulatory hurdles to this approach. Issues with physicochemical compatibility and mismatched PK argue against free combinations. How about combining Avycaz with another BL?\u00a0 This would create an imbalance in the ratio of BL : BLI; it may still work but should first be explored in relevant preclinical animal models.<\/p>\n

#3: TRUE BLUE NCEs \u2013 A SMALL GROUP BUT MOST DESERVING<\/strong>
\nWhen we look for NCEs in our list of QIDP drugs, we find only precious\u00a0few systemically active agents. Some may already be on life support, no longer actively pursued. All of them struggle with regulatory guidelines that don’t apply, and with marketing departments that see little commercial value.<\/p>\n

Let us not dwell on the negatives \u2013 here are some of the most exciting drugs in development which we follow with great interest:\"table-of-nce-for-blog\"<\/a><\/p>\n

Please see\u00a0more detailed informations in\u00a0prior blogs of\u00a0these compounds on our website.<\/p>\n","protected":false},"excerpt":{"rendered":"

According to Janet Woodcock, 63 drugs have been given the \u201cQIDP\u201d designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development.\u00a0 So we are in fairly close agreement. That may seem like an impressive record but it is also Continue reading QIDP Drug Update \u2013 Part 2: \u00a0Categories of Interest<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2856,"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":true,"_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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[19,227,3,18],"tags":[1271,403,585,974,336,874,892,828,1467,347,876,1769,1771,1306,1770,246,1583,878,1768,813,245,567,1772,622,1775,1472,1361,348,117,171,173,1371,886,1777,1774,604,1773,1637,1776],"class_list":["post-2817","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-recent_literature","category-the_news","category-the_viewpoint","tag-allphase-pharma-consulting","tag-antibiotic-blog","tag-astrazeneca","tag-avycaz","tag-aztreonam","tag-brilacidin","tag-bronchiectasis","tag-ceftaroline","tag-ceftarolineavibactam","tag-ceftazidime","tag-cellceutix","tag-chitin-synthase-inhibitor","tag-ctazavi","tag-entasis","tag-gepotidacin","tag-gsk","tag-harald-reinhart","tag-lefamulin","tag-lptd-inhibitor","tag-n-gonorrhoeae","tag-nabriva","tag-ndm","tag-new-delhi-metallobetalactamase","tag-nikz","tag-non-tuberculous-mycobacteria","tag-ntm","tag-peptidomimetic","tag-piperacillintazobactam","tag-pleuromutilin","tag-pol-7080","tag-polyphor","tag-qidp","tag-tobi","tag-tobramycin-inhaler","tag-vabp-treatment","tag-valley-fever-solutions","tag-vapb-prophylaxis","tag-zoliflodacin","tag-zosyn"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/10\/QIDP-Part2-slider.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-Jr","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":3116,"url":"https:\/\/allphasepharma.com\/dir\/2017\/01\/30\/3116\/txa-709-kid-qidp-block\/","url_meta":{"origin":2817,"position":0},"title":"TXA-709 –\u00a0 New Kid on the Block","author":"Harald","date":"January 30, 2017","format":false,"excerpt":"When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is still in preclinical testing. The drug\u2019s target, bacterial replication machinery\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\/01\/FtsZ-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/01\/FtsZ-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/01\/FtsZ-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2911,"url":"https:\/\/allphasepharma.com\/dir\/2016\/11\/25\/2911\/prospecting-antibiotics\/","url_meta":{"origin":2817,"position":1},"title":"Prospecting for New Antibiotics","author":"Harald","date":"November 25, 2016","format":false,"excerpt":"The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. 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Today just\u00a0facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are\u00a058 drugs which garnered QIDP status and these are listed in the Main Table below. With the recent\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\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":1332,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/28\/1332\/drugs-with-qidp-designation-update-3282015\/","url_meta":{"origin":2817,"position":3},"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":1800,"url":"https:\/\/allphasepharma.com\/dir\/2015\/08\/01\/1800\/qidp-drugs-4th-edition\/","url_meta":{"origin":2817,"position":4},"title":"QIDP Drugs – 4th Edition","author":"Harald","date":"August 1, 2015","format":false,"excerpt":">>> For the latest QIDP list, please click HERE \u00a0<<< Since our\u00a0last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table\u00a0which includes compound, sponsor\u00a0and development stage (Phase). It also indicates whether a drug has been\u00a0the topic of a\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"QIDP 4th edition","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/QIDP-4th-edition.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":2817,"position":5},"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":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/2817","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=2817"}],"version-history":[{"count":11,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/2817\/revisions"}],"predecessor-version":[{"id":2858,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/2817\/revisions\/2858"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media\/2856"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=2817"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=2817"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=2817"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}