{"id":1168,"date":"2014-12-15T02:23:38","date_gmt":"2014-12-15T07:23:38","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1168"},"modified":"2014-12-15T03:59:26","modified_gmt":"2014-12-15T08:59:26","slug":"the-circuitous-route-to-phase-3-another-chapter-in-the-fitful-development-of-ptk-0796","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/12\/15\/1168\/the-circuitous-route-to-phase-3-another-chapter-in-the-fitful-development-of-ptk-0796\/","title":{"rendered":"The Circuitous Route to Phase 3:\u00a0 Another Chapter in the Fitful Development of PTK-0796"},"content":{"rendered":"

When antibiotics change hands, it can be a good thing.\u00a0 Small companies are often desperate to attract a partner with \u2018deep pockets\u2019 to help them finance an expensive late phase development but often have to give up control once\u00a0the honeymoon period is over.\u00a0 Such transitions can bring delays because new teams need to come up to speed and new objectives require adjustment to the Clinical Development Plan (CDP).\"Detour-1\"<\/a><\/p>\n

One would assume that the last thing the acquiring company wants is a loss of momentum.\u00a0 In a small company, the few development assets get all the attention.\u00a0 However, as one of many projects in a corporation even a newly acquired compound can easily become deprioritized for internal or external reasons.\u00a0 As we all know, changes in the regulatory environment \u2013 like infeasible new FDA guidelines \u2013 have caused companies to move away from a particular ID projects or to abandon the entire Therapeutic Area of anti-infectives.<\/p>\n

Paratek\u2019s omadacycline (PTK-0796) is a case in point.\u00a0 It must be the record holder for collaboration deals and, still, more than others it was tossed around by the whims of shifting corporate priorities.\u00a0 For a drug with a very broad Gram-negative activity, including MDR pathogens, one would have expected development in the fast lane but the fate of PTK-0796 more resembles a rollercoaster ride:\u00a0 First partnered with GSK, then with Bayer (now called BAY 73-6944\/PTK\u00a00796), followed by Merck for Phase 1 development (not sure whether Merck actually did any studies), the compound was finally inlicensed by Novartis in Phase 2\u00bd.\u00a0 After a few years without recognizable progress the marriage was over before the drug even advanced into Phase 3.<\/p>\n

Now we hear about the reverse merger with Transcept and that it would enable Paratek to finally start a pivotal Phase 3 program in ABSSSI.\u00a0 Here the timeline:<\/p>\n

2014\u00a0\u00a0\u00a0\u00a0\u00a0 Paratek merges with Transcept
\n2009\u00a0\u00a0\u00a0\u00a0\u00a0 Deal with Novartis \u2013 it fell apart for unclear reasons in 2011
\n2005\u00a0\u00a0\u00a0\u00a0\u00a0 Deal with Merck \u2013 it fell apart over \u201cdifference in opinion about future direction of development\u201d[1]
\n<\/a>2003 \u00a0 \u00a0 \u00a0Deal with Bayer \u2013 it fell apart when Bayer \u201cturned its attention elsewhere\u201d[2]
\n<\/a>1999 \u00a0 \u00a0 \u00a0Deal with Glaxo \u2013 it fell apart when GSK \u201cpulled support for antibacterial R&D\u201d[3]<\/a><\/p>\n

Just to be clear:\u00a0 Before the collaboration with Novartis, Paratek had started a Phase 3 program on its own which was\u00a0stopped prematurely (when the company ran out of money?).\u00a0 It seems Phase 3 was started on a wing and a prayer hoping to attract a suitor fancying a Phase 3 program.\u00a0 This effort of \u2018dressing up the bride\u2019 did not work quite as expected: the study was stopped after enrolling only 143 of 790 patients planned.[4]<\/a>\u00a0 Now, 4-5 years later, Transcept will have to start Phase 3 again.<\/p>\n

Currently, Clinicaltrials.gov does not list any ongoing Phase 3 trials although the company seems to have received Special Protocol Assessment (SPA) for its new ABSSSI protocols and should be raring to go.<\/p>\n

In summary, it took approx. 12 years to get this drug from IND to Phase 3.\u00a0 It sure must be a big disappointment to see that late-starter eravacycline (from Tetraphase) now has caught up with omadacycline and is much closer to an NDA filing.<\/p>\n

While VC companies can be counted on to run rings around \u2018Big Pharma\u2019 when it comes to development speed, PTK-0796 seems to be the exception that proves the rule.<\/p>\n

There is a bit of good news of late:\u00a0 FDA granted omadacycline QIDP status.\u00a0 Let\u2019s hope Transcept does not use up this patent extension trying to find a new partner.<\/p>\n

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

[1]<\/a> http:\/\/ojs.pharmadeals.net:5555\/index.php\/pdr\/article\/viewFile\/cr%201390\/pdf
\n[2]<\/a> http:\/\/www.serkadis.com\/health\/12292
\n[3]<\/a> https:\/\/www.msu.edu\/course\/mmg\/445\/Lecture%20Notes_files\/BarettJS.pdf
\n[4]<\/a> http:\/\/www.bioworld.com\/content\/antibiotic-firm-paratek-joins-ipo-queue-aiming-92m-0<\/p>\n","protected":false},"excerpt":{"rendered":"

When antibiotics change hands, it can be a good thing.\u00a0 Small companies are often desperate to attract a partner with \u2018deep pockets\u2019 to help them finance an expensive late phase development but often have to give up control once\u00a0the honeymoon period is over.\u00a0 Such transitions can bring delays because new Continue reading The Circuitous Route to Phase 3:\u00a0 Another Chapter in the Fitful Development of PTK-0796<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1172,"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":[19,3,18],"tags":[81,220,425,99,246,588,433,713,715,435,714],"class_list":["post-1168","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-the_news","category-the_viewpoint","tag-absssi","tag-bayer","tag-eravacycline","tag-fda-guidance","tag-gsk","tag-merck","tag-omadacycline","tag-ptk-0796","tag-spa","tag-tetraphase","tag-transcept"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/12\/PTK-slider-copy.jpg?fit=640%2C200&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-iQ","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1946,"url":"https:\/\/allphasepharma.com\/dir\/2015\/09\/21\/1946\/allphase-pharma-the-first-100-blog-posts\/","url_meta":{"origin":1168,"position":0},"title":"ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS","author":"Harald","date":"September 21, 2015","format":false,"excerpt":"After the first 100 blogs, it is appropriate to reflect on reader preferences.\u00a0 When I arbitrarily select a topic, it is not always clear whether what interests me also interests you. 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The authors measured total and free (i.e.,\u00a0nonprotein-bound) eravacycline levels at ascending doses in a mouse model. They found strikingly small increases in free drug levels when titrating up\u00a0total doses. The effect was rather dramatic: an increase in\u00a0protein binding from 12%\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"Horserace Tigecycline Erava","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/09\/Horserace-Tigecycline-Erava.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/09\/Horserace-Tigecycline-Erava.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/09\/Horserace-Tigecycline-Erava.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":269,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/16\/269\/the-antibiotic-pipeline-how-new-is-new\/","url_meta":{"origin":1168,"position":4},"title":"The Antibiotic Pipeline: How \u201cNew\u201d is New","author":"Harald","date":"June 16, 2014","format":false,"excerpt":"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\u2026","rel":"","context":"In "The Viewpoint"","block_context":{"text":"The Viewpoint","link":"https:\/\/allphasepharma.com\/dir\/category\/the_viewpoint\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/new-3-pipelines.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/new-3-pipelines.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/new-3-pipelines.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":2802,"url":"https:\/\/allphasepharma.com\/dir\/2016\/10\/18\/2802\/qidp-drug-update-part-1-an-updated-who-is-who\/","url_meta":{"origin":1168,"position":5},"title":"QIDP Drug Update \u2013 Part 1: An Updated Who Is Who","author":"Harald","date":"October 18, 2016","format":false,"excerpt":"It is time for a new look at the field of QIDP drugs. 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