{"id":2157,"date":"2015-12-03T04:30:17","date_gmt":"2015-12-03T09:30:17","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2157"},"modified":"2016-03-23T04:39:09","modified_gmt":"2016-03-23T08:39:09","slug":"there-is-momentum-building-for-rsv-therapeutics","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/12\/03\/2157\/there-is-momentum-building-for-rsv-therapeutics\/","title":{"rendered":"There is Momentum Building for RSV Therapeutics"},"content":{"rendered":"

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

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 as prevalent as influenza which causes significant disease in the newborn is clearly a high-need area.\u00a0 Prophylaxis in high-risk children has already made palivizumab\/Synagis a 1 billion USD drug. This disease should either be preventable with a vaccine or at least become more manageable with an antiviral. Even significant symptomatic improvement would be progress and create a blockbuster.<\/p>\n

The label for Synagis is quite\u00a0restrictive and it is quite amazing that this antibody has become\u00a0so lucrative.\u00a0 Clearly, Medimmune was anxious to replace palivizumab with motavizumab (MEDI-524, Numax) ahead of the patent expiry for Synagis last month (October 2015), but things did not work out as planned. Although Numax was a monoclonal antibody with 20-times higher affinity for\u00a0the F-(fusion) glycoprotein of RSV, this affinity advantage did not translate into higher clinical efficacy when compared to Synagis.\u00a0 Even more unfortunately, Numax was associated with rashes and hypersensitivity reactions, including urticarial, in approx. 1% of patients.\u00a0 Despite some theoretical benefits, the 2010 Antiviral Drugs Advisory Committee voted against approval, and FDA followed that advice.\u00a0 Now, years after that decision, we learn about a study conducted with motavizumab which is\u00a0truly impressive.\u00a0 And the clinical findings are very impressive as well.<\/p>\n

O\u2019Brien and the team at MedImmune report the results of an RSV disease prevention study conducted with motovizumab (Numax) in a large population of infants from the Navajo and Apache nations, a particularly high-incidence population for RSV\u00a0[1]<\/a>. Over 4 consecutive fall\/winter seasons, they were able to enroll 2127 evaluable infants who received motavizumab in 5 monthly injections.\u00a0 The results were impressive: Overall, treatment with motavizumab prevented 87% of infections that would have led\u00a0to hospitalization for lower tract respiratory disease due to RSV.\u00a0 Even in the outpatient setting, treatment with motavizumab was highly effective in preventing RSV-related\u00a0lower tract respiratory disease: here 71% was the\u00a0protection level.<\/p>\n

No significant safety issues were identified; in fact, the placebo arm looked numerically worse than the Numax group. However, the authors mention that some children developed hypersensitivity reactions to motavizumab that required urgent care, a reminder of the concerns raised at\u00a0the Antiviral Drugs Advisory Committee.<\/p>\n

With 20\/20 hindsight, similar results could have been achieved by Synagis in this population had the same study been done. \u00a0It would have broadened the indications for palivizumab and provided a new prophylaxis option which currently does not exist.<\/p>\n

This was a beautifully executed trial; it had all the quality markers you could wish for:\u00a0 Central lab processing, long-term f\/u, interim analysis, blinded data review, independent data monitoring committee. It showed (again) that monoclonal antibody prophylaxis works: RSV incidence can be reduced significantly, even if disease severity \u2013 once illness strikes – is not improved.<\/p>\n

It is a pity\u00a0publication of study results was delayed by 5 years. A trial like this creates a lot of good will towards industry; it deserves to be highlighted as an example of excellence in study design and execution.<\/span><\/p>\n<\/div>\n

With Numax no longer being developed and not getting much attention in-house at MedImmune, this publication had a long gestation period. \u00a0First results were communicated to ‘the community\u2019 in 2011, i.e., 1 year after the end of the trial. Unfortunately,\u00a0it took 4 more years for this publication to appear in print.<\/p>\n

Just as this article is being\u00a0published, we learn that Novavax has initiated a large placebo-controlled Phase 2 trial of its candidate RSV vaccine, directed against the F-gp as well.\u00a0 This is a study of immunogenicity in elderly patients. And we have not even mentioned the Alios compound yet, ALS-008176 (aka AL-8176) which after the\u00a0merger is now being developed by Johnson & Johnson.<\/p>\n

We will keep an eye on these and other anti-RSV therapeutics and report progress in future blogs.<\/p>\n

References:
\n<\/strong>[1]<\/a> O\u2019Brien, K. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial\u00a0 <\/strong>Lancet Infect Dis 2015; 15: 1398\u2013408<\/p>\n","protected":false},"excerpt":{"rendered":"

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 Continue reading There is Momentum Building for RSV Therapeutics<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2159,"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":[227,3,18],"tags":[778,1446,1444,1271,1445,403,1452,1449,126,502,1583,1163,379,1447,1180,1440,1448,1443,1450,1441,501,500,1442],"class_list":["post-2157","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recent_literature","category-the_news","category-the_viewpoint","tag-aidac","tag-al-8176","tag-alios","tag-allphase-pharma-consulting","tag-als-008176","tag-antibiotic-blog","tag-antiviral-drugs-advisory-committee","tag-fda-rejection","tag-gilead","tag-gs-5806","tag-harald-reinhart","tag-johnson-johnson","tag-mab","tag-medi-524","tag-medimmune","tag-motavizumab","tag-novavax","tag-numax","tag-numax-efficacy","tag-palivizumab","tag-respiratory-syncytial-virus","tag-rsv","tag-synagis"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/RSV-banner-copy.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-yN","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":771,"url":"https:\/\/allphasepharma.com\/dir\/2014\/08\/28\/771\/following-the-publication-trail-of-two-rsv-drugs\/","url_meta":{"origin":2157,"position":0},"title":"Following The Publication Trail of Two RSV Drugs","author":"Harald","date":"August 28, 2014","format":false,"excerpt":"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\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"RSV from Ref. 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