{"id":793363,"date":"2024-12-09T08:18:17","date_gmt":"2024-12-09T13:18:17","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/"},"modified":"2024-12-09T08:18:17","modified_gmt":"2024-12-09T13:18:17","slug":"bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/","title":{"rendered":"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li style=\"text-align:left\">BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4<\/li>\n<li style=\"text-align:left\">Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2 2025<\/li>\n<\/ul>\n<p align=\"justify\">ADELAIDE, Australia,\u00a0and CAMBRIDGE, Mass., Dec.  09, 2024  (GLOBE NEWSWIRE) &#8212; Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that the positive results from its Phase 2 ATTUNE study have been published in the <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=VLL73fehn1fyrQGGyipQBUNWHzaen85BZdJn5WtO3Ws3hPz0P6ZBxIzvlsi9lGwnAVL0Tj5HYwzauTpb16UbgMBpcTwGcKva7oxZgdfytcaeI4RhQFZU4uYN7OuoLW_4\" rel=\"nofollow\" target=\"_blank\"><em>NEJM Evidence<\/em><\/a>. The data were also presented yesterday at the 63\u02b3\u1d48 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) as part of the inaugural \u201cPromising Targets\u201d session.<\/p>\n<p>\u201cWe are excited to publish the results of the ATTUNE in <em>NEJM Evidence<\/em>, a prestigious journal for innovative original research. This peer-reviewed publication further validates these significant results and underscores the differentiated clinical profile of BNC210, a potential best- and first-in class treatment for PTSD that is non-psychedelic, non-sedating and non-habit-forming,\u201d said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. \u201cSince our successful End-of-Phase 2 meeting with the FDA earlier this year, we have been diligently preparing for the Phase 3 study of BNC210 in PTSD which we anticipate initiating in the second half of 2025, if not sooner.\u201d<\/p>\n<p align=\"justify\">Key results from the publication include:<\/p>\n<ul type=\"disc\">\n<li style=\"text-align:justify\">Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score improvement was observed with BNC210 compared with placebo (p=0.048) at Week 12 with improvement seen as early as Week 4<\/li>\n<li style=\"text-align:justify\">Clinically meaningful and statistically significant improvements were also observed with BNC210 vs placebo in:\n<ul type=\"circle\">\n<li style=\"text-align:justify\">Depressive symptoms measured on the Montgomery\u2013\u00c5sberg Depression Rating Scale<\/li>\n<li style=\"text-align:justify\">Sleep measured on the Insomnia Severity Index<\/li>\n<\/ul>\n<\/li>\n<li style=\"text-align:justify\">Treatment-emergent adverse events (AEs) occurred in 70 (66.7%) patients in the BNC210 group and 56 (53.8%) in the placebo group. The most common AEs were headache, nausea, fatigue, and hepatic enzyme elevations.<\/li>\n<\/ul>\n<p align=\"justify\">\u201cThis publication highlights the encouraging and clinically meaningful improvements seen with BNC210 across several key PTSD symptoms,\u201d commented Murray B Stein, M.D., M.P.H.; Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and a senior author of the paper. \u201cFewer than 50% of patients experience benefit with currently approved treatments and therefore there is a pressing need for new, well-tolerated, efficacious treatments. The ATTUNE data, along with the additional clinical data of BNC210 to date, positions it as a promising potential treatment and I look forward to further seeing it assessed it in a larger Phase 3 trial.\u201d<\/p>\n<p align=\"justify\">The Company is planning to initiate the Phase 3 trial in PTSD in the second half of 2025. BNC210 is also being evaluated in a Phase 3 AFIRM-1 study in social anxiety disorder (SAD) with anticipated readout in Q3 2025.<\/p>\n<p align=\"justify\">\n        <strong>FOR FURTHER INFORMATION PLEASE CONTACT: <\/strong>\n      <\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:34%;width:34%;min-width:34%;text-align: left;vertical-align: middle;vertical-align: top\">\n            <strong>General<\/strong><br \/>\n            <br \/>Rajeev Chandra <br \/>Company Secretary<br \/><a href=\"mailto:CoSec@bionomics.com.au\" rel=\"nofollow\" target=\"_blank\"><u>CoSec@bionomics.com.au<\/u><\/a><\/td>\n<td style=\"max-width:33%;width:33%;min-width:33%;text-align: left;vertical-align: middle;vertical-align: top\">\n            <strong>Investor Relations<\/strong><br \/>\n            <br \/>Kevin Gardner<br \/><a href=\"mailto:kgardner@lifesciadvisors.com\" rel=\"nofollow\" target=\"_blank\">kgardner@lifesciadvisors.com<\/a><\/p>\n<\/td>\n<td style=\"max-width:33%;width:33%;min-width:33%;text-align: left;vertical-align: middle;vertical-align: top\">\n            <strong>Investor Relations<\/strong><br \/>\n            <br \/>Chris Calabrese<br \/><a href=\"mailto:ccalabrese@lifesciadvisors.com\" rel=\"nofollow\" target=\"_blank\">ccalabrese@lifesciadvisors.com<\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;vertical-align: middle;vertical-align: top\">\u00a0<\/td>\n<td style=\"text-align: left;vertical-align: middle;vertical-align: top\">\u00a0<\/td>\n<td style=\"text-align: left;vertical-align: middle;vertical-align: top\">\u00a0<\/td>\n<\/tr>\n<\/table>\n<p>\n        <strong>About Bionomics Limited<\/strong><br \/>\n        <br \/>Bionomics (NASDAQ: BNOX) is a clinical-stage biotechnology company developing novel, potential first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the \u03b17 nicotinic acetylcholine receptor, for the acute treatment of social anxiety disorder (SAD) and chronic treatment of post-traumatic stress disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck &amp; Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer\u2019s disease and other CNS conditions. Bionomics\u2019 pipeline also includes preclinical assets that target Kv3.1\/3.2 and Nav1.7\/1.8 ion channels being developed for CNS conditions of high unmet need.www.bionomics.com.au<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>Bionomics cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as \u201cmay,\u201d \u201ccould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cplan,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cpredict,\u201d \u201cseek,\u201d \u201ccontemplate,\u201d \u201cpotential,\u201d \u201ccontinue\u201d or \u201cproject\u201d or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the closing of each tranche of the Company\u2019s private placement financing, the achievement of certain milestones for the various tranches, the timely funding to the Company by each investor in the private placement, the timing, size and expectation of the closing of the private placement; and expectations regarding market conditions, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom; and the Company\u2019s expectation that its current cash, cash equivalents, and marketable securities will fund our operations into the third quarter of 2025. The inclusion of forward-looking statements should not be regarded as a representation by Bionomics that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company\u2019s business and other risks described in the Company\u2019s filings with the Securities and Exchange Commission (SEC), including, but not limited to, the Company\u2019s Annual Report on Form 20-F filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Bionomics undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Bionomics\u2019 filings with the SEC, copies of which are available from the SEC\u2019s website (www.sec.gov) and on Bionomics\u2019 website (www.bionomics.com.au) under the heading \u201cInvestor Center.\u201d All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Bionomics expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxNTA4NSM2NjI1NjE0IzIyNDQxNzE=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZDI1ZDkyYmItZjhiMy00MzliLTkwNmQtNTA5MTZiMjZkNTU0LTEyNTU3MjQ=\/tiny\/Bionomics-Ltd.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4 Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2 2025 ADELAIDE, Australia,\u00a0and CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) &#8212; Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that the positive results from its Phase 2 ATTUNE study have been published in the NEJM Evidence. The data were also presented yesterday at the 63\u02b3\u1d48 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) as part of the inaugural \u201cPromising Targets\u201d session. &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-793363","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4 Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2 2025 ADELAIDE, Australia,\u00a0and CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) &#8212; Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that the positive results from its Phase 2 ATTUNE study have been published in the NEJM Evidence. The data were also presented yesterday at the 63\u02b3\u1d48 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) as part of the inaugural \u201cPromising Targets\u201d session. &hellip; Continue reading &quot;Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-09T13:18:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxNTA4NSM2NjI1NjE0IzIyNDQxNzE=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence\",\"datePublished\":\"2024-12-09T13:18:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\\\/\"},\"wordCount\":1026,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTMxNTA4NSM2NjI1NjE0IzIyNDQxNzE=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\\\/\",\"name\":\"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/","og_locale":"en_US","og_type":"article","og_title":"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence - Market Newsdesk","og_description":"BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4 Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2 2025 ADELAIDE, Australia,\u00a0and CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) &#8212; Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that the positive results from its Phase 2 ATTUNE study have been published in the NEJM Evidence. The data were also presented yesterday at the 63\u02b3\u1d48 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) as part of the inaugural \u201cPromising Targets\u201d session. &hellip; Continue reading \"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/","og_site_name":"Market Newsdesk","article_published_time":"2024-12-09T13:18:17+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxNTA4NSM2NjI1NjE0IzIyNDQxNzE=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence","datePublished":"2024-12-09T13:18:17+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/"},"wordCount":1026,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxNTA4NSM2NjI1NjE0IzIyNDQxNzE=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/bionomics-publishes-the-positive-results-from-the-phase-2-attune-study-of-bnc210-in-patients-with-post-traumatic-stress-disorder-in-nejm-evidence\/","name":"Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence - 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