{"id":771,"date":"2014-08-28T20:42:22","date_gmt":"2014-08-29T00:42:22","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=771"},"modified":"2016-02-02T06:50:30","modified_gmt":"2016-02-02T11:50:30","slug":"following-the-publication-trail-of-two-rsv-drugs","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/08\/28\/771\/following-the-publication-trail-of-two-rsv-drugs\/","title":{"rendered":"Following The Publication Trail of Two RSV Drugs"},"content":{"rendered":"

\"RSV<\/a>
RSV – Ref. [6]<\/figcaption><\/figure>In a publication from 2007, investigators from Arrow Pharmaceuticals told us that A-60444 (later renamed to\u00a0RSV-604) was already in Phase 2.\u00a0 Since then, it has been very quiet about this compound.\u00a0 Some have suggested that Novartis has stopped development [1], an impression supported by the fact that the drug is not mentioned on the Novartis Clinical Pipeline chart which lists drugs in development\u00a0 [2].<\/p>\n

We still have only scant clinical information on RSV604: \u00a0from\u00a0the Phase 1 trial we only have a company poster [3], \u00a0and from\u00a0the PoC trial in stem cell transplant patients there is\u00a0a\u00a0conference report [4].\u00a0 Clearly, the data did not justify the initial enthusiasm. \u00a0And nobody really likes\u00a0to tie up loose ends for an abandoned compound\u00a0or\u00a0work on\u00a0a full-fledged publication when\u00a0results were disappointing. \u00a0Nonetheless, the patients that altruistically participate in a research trial in order to advance science deserve better.<\/p>\n

The story of GS-5806 is just the opposite.\u00a0 Just a few months after study completion,\u00a0the positive results are published with fanfare and great detail in the NEJM [5].\u00a0 There is not only a\u00a0main summary article, but also a supplemental appendix describing statistics and secondary data. \u00a0Even the full protocol is available, thanks for asking.\u00a0 The Journal has an editorial ready for the occasion and a nice commentary about the ethics and history of human experimentation with infectious agents. \u00a0Everyone\u00a0must have fast-tracked this publication right from the moment the blind was broken.<\/p>\n

\"GS-5806\"<\/a>
GS-5806<\/figcaption><\/figure>\n

There is no argument here: \u00a0Patients really will benefit from a drug that works in RSV infections.\u00a0 Gilead is on track with GS-5806 in this effort providing efficacy data from a nicely executed\u00a0study. \u00a0Let’s give credit where it’s due:<\/p>\n

RSV studies are notoriously difficult: there is no established precedent, there is no surrogate marker, the clinical presentation is non-specific and the virus is not causing viremia.\u00a0 As a mucosal disease, there is great inter- and intraindividual variability of viral shedding over time.\u00a0 Sampling respiratory secretions is a messy way of generating quantitative data.\u00a0 There is also no good animal model for testing as animal strains are not infecting humans and vice versa.\u00a0 Not surprisingly, the field is littered with poorly executed studies.\u00a0 Therefore, my congratulations to DeVincenzo and the Gilead team for executing an innovative study successfully.

\u00a0\u00a0Overall US hospitalization rates for influenza and RSV are similar \u00a0 \u00a0<\/span>H Zhou. CID\u00a02012; 54:1427 \u00a0<\/span><\/p>\n<\/div><\/p>\n

\u00a0References:<\/strong><\/p>\n

[1] H. Costello.\u00a0 http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3835183\/
\n[2] http:\/\/www.novartis.com\/innovation\/research-development\/clinical-pipeline\/index.shtml
\n[3] J. Dent. 45th<\/sup> ICAAC, Washington, DC, 2005, Poster F-483
\n[4] F Marty.\u00a0 IXth International Symposium on Respiratory Viral Infections.\u00a0 Causeway Bay, Hong Kong, Mar 3-6, 2007
\n[5] J. DeVincenzo.\u00a0 NEJM 371: 8, 2014
\n[6] \u00a0www.niehs.nih.gov<\/span><\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

In a publication from 2007, investigators from Arrow Pharmaceuticals told us that A-60444 (later renamed to\u00a0RSV-604) was already in Phase 2.\u00a0 Since then, it has been very quiet about this compound.\u00a0 Some have suggested that Novartis has stopped development [1], an impression supported by the fact that the drug is Continue reading Following The Publication Trail of Two RSV Drugs<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":777,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[3,18],"tags":[429,505,503,507,126,502,508,174,506,501,500,504],"class_list":["post-771","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the_news","category-the_viewpoint","tag-antibiotics-blog","tag-ar-60444","tag-arrow","tag-devincenzo","tag-gilead","tag-gs-5806","tag-nejm","tag-novartis","tag-publication-bias","tag-respiratory-syncytial-virus","tag-rsv","tag-rsv-604"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/08\/rsv.jpg?fit=300%2C217&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-cr","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":2157,"url":"https:\/\/allphasepharma.com\/dir\/2015\/12\/03\/2157\/there-is-momentum-building-for-rsv-therapeutics\/","url_meta":{"origin":771,"position":0},"title":"There is Momentum Building for RSV Therapeutics","author":"Harald","date":"December 3, 2015","format":false,"excerpt":"Sometimes \u2013 for no obvious reason \u2013 there is a flurry of publications from a particular area which has been quiet for a long time.\u00a0 RSV is such an area where new drug development had a hard time getting started.\u00a0 There was always the lure of big money: an infection\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"RSV - banner copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/RSV-banner-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/RSV-banner-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/RSV-banner-copy.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1314,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/25\/1314\/aerosolized-antibiotics-selling-nebulizers\/","url_meta":{"origin":771,"position":1},"title":"Aerosolized Antibiotics & Selling Nebulizers","author":"Harald","date":"March 25, 2015","format":false,"excerpt":"\u201cThe medicine comes for free, just pay us for the inhaler\u201d should be the marketing slogan for this group of therapeutics.\u00a0 Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to \u2018evergreen\u2019 off-patent antibiotics. The inhalational route to administer antibiotics is clearly attractive.\u00a0\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":577,"url":"https:\/\/allphasepharma.com\/dir\/2014\/07\/11\/577\/bacterial-vaccine-targets\/","url_meta":{"origin":771,"position":2},"title":"Bacterial Vaccine Targets","author":"Harald","date":"July 11, 2014","format":false,"excerpt":"A recent publication [1] from the team which brought us the Meningococcal B vaccine is of interest from the perspective of vaccine development strategy and feasibility.\u00a0 Appropriately, tuberculosis (TB) leads the list of important bacterial targets for vaccine research. Despite numerous attempts, all the vaccines candidate tested so far had\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"Bacterial Targets","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/07\/Bacterial-Targets-Rappuoli.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":420,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/26\/420\/fighting-p-aeruginosa-part-ii\/","url_meta":{"origin":771,"position":3},"title":"Fighting P. aeruginosa (Part II)","author":"Harald","date":"June 26, 2014","format":false,"excerpt":"At a still earlier stage of development, we found\u00a0some exciting\u00a0anti-pseudomonal compounds. First, there is BAL-30072, a sulfactam-derivative.\u00a0 It has an interesting dual MoA as it works not only as a traditional B-lactam but also as an Fe-chelator blocking bacteria from accessing this essential nutrient [i].\u00a0 It has very good anti-pseudomonas\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"PipTazo","src":"http:\/\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/PipTazo.jpe","width":350,"height":200},"classes":[]},{"id":6362,"url":"https:\/\/allphasepharma.com\/dir\/2026\/03\/31\/6362\/igan-therapeutics-the-race-is-on\/","url_meta":{"origin":771,"position":4},"title":"IgAN Therapeutics – The Race is On","author":"Harald","date":"March 31, 2026","format":false,"excerpt":"Is there a new trend in the journal world: \u00a0publication of interim analysis (IA) results? The NEJM recently published two articles back to back, both highlighting 9 month 'interim' data from Phase 3 pivotal trials in IgAN. The primary efficacy endpoint used in either study was UPCR at 9 months,\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/03\/UPCR-vs-GFR.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/03\/UPCR-vs-GFR.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/03\/UPCR-vs-GFR.jpg?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":378,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/23\/378\/fighting-p-aeruginosa-part-i\/","url_meta":{"origin":771,"position":5},"title":"Fighting P. aeruginosa (Part I)","author":"Harald","date":"June 23, 2014","format":false,"excerpt":"It has never been easy to cure Pseudomonas aeruginosa infections.\u00a0 Few antibiotics nowadays have reliable activity against this problem pathogen that seems to have more built-in resistance features than most other Gram-negatives.\u00a0 In the past, cephalosporins, aztreonam, penems, ciprofloxacin, and aminoglycosides were useful drugs with reliably cidal activity, especially when\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"PA-01 on Agar","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/PA-01-on-Agar-300x274.jpg?resize=350%2C200","width":350,"height":200},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/771","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=771"}],"version-history":[{"count":16,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/771\/revisions"}],"predecessor-version":[{"id":2283,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/771\/revisions\/2283"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media\/777"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}