{"id":61836,"date":"2025-09-09T13:06:51","date_gmt":"2025-09-09T11:06:51","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/newleos-therapeutics-announces-poster-presentation-to-be-featured-at-the-2025-world-congress-of-biological-psychiatry\/"},"modified":"2025-09-09T13:06:51","modified_gmt":"2025-09-09T11:06:51","slug":"newleos-therapeutics-announces-poster-presentation-to-be-featured-at-the-2025-world-congress-of-biological-psychiatry","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/newleos-therapeutics-announces-poster-presentation-to-be-featured-at-the-2025-world-congress-of-biological-psychiatry\/","title":{"rendered":"Newleos Therapeutics Announces Poster Presentation to be Featured at the 2025 World Congress of Biological Psychiatry"},"content":{"rendered":"
\n

\n\u2013 Results of preclinical studies on selective GABAA<\/sub> \u03b31 positive allosteric modulators (PAMs) in anxiety models support further clinical development of NTX-1955 <\/i>\u2013<\/p>\n

BOSTON–(BUSINESS WIRE)–#AnxietyDisorders<\/a>—Newleos Therapeutics, Inc.<\/a>, a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the presentation of a poster related to the company\u2019s first-in-class GABAA<\/sub> \u03b31 positive allosteric modulator (PAM), NTX-1955, at the 17th<\/sup> World Congress of Biological Psychiatry (WCBP). Organized by the World Federation of Societies of Biological Psychiatry, WCBP is taking place September 9-12 in Berlin, Germany. Newleos is conducting two Phase 1b studies in the European Union (EU) to assess the pharmacology and proof-of-mechanism for NTX-1955 in Generalized Anxiety Disorder (GAD).<\/p>\n

<\/a>
<\/a><\/p>\n

\nThe presentation highlights for the first time groundbreaking preclinical work that led to the discovery of selective GABAA<\/sub> \u03b31 PAMs. These studies demonstrated that GABAA<\/sub> \u03b31 PAMs have high affinity and functional selectivity for the \u03b31 subunit-containing GABAA<\/sub> receptor, unlike classical benzodiazepines, a class of anxiety medications that target \u03b32 subunit-containing GABAA<\/sub> receptors and are limited by their side effects. Ex-vivo<\/i> electrophysiological studies demonstrated effective positive allosteric modulation by GABAA<\/sub> \u03b31 PAMs of inhibitory synapses in the amygdala, a key node in the brain regulating anxiety. Receptor occupancy studies using a novel \u03b31-selective radioligand confirmed dose-dependent target binding in the amygdala. Additionally, functional imaging studies revealed distinct, large-scale neural activity changes induced by GABAA<\/sub> \u03b31 PAMs indicative of a superior molecular profile relative to other GABAA<\/sub> receptor potentiators. In well-established behavioral assays, GABAA<\/sub> \u03b31 PAMs exhibited dose-dependent efficacy, reducing anxiety-like behavior without the side effects commonly associated with \u03b32-targeting benzodiazepines, including sedation, cognitive and motor impairment, among others.<\/p>\n

\nFederico Bolognani, M.D., Ph.D., Co-Founder and Chief Medical Officer at Newleos and a co-author on the presentation, commented, \u201cThe discovery of the first selective and potent GABAA<\/sub>-\u03b31 PAMs represents a meaningful advance toward potential next-generation treatments for anxiety. With NTX-1955, Newleos is developing the first clinical-stage modulator of GABAA<\/sub>-\u03b31 receptors in the amygdala\u2014the brain region most directly linked to anxiety\u2014aimed at delivering the powerful anxiolytic benefits of benzodiazepines without the drawbacks of sedation, cognitive impairment, or dependence. We look forward to presenting results from our ongoing clinical studies at upcoming industry meetings.\u201d<\/p>\n

\nWCBP Poster Presentation<\/span>:
\n
<\/b>Poster Number: W36
\n
Title: A Novel Approach for Anxiety Treatment: Discovery of Selective GABAA<\/sub> \u03b31 Positive Allosteric Modulators for Targeted Modulation of Extended Amygdala Circuits
\n
<\/i><\/b>Presenting Author: Maria-Clemencia Hernandez, Ph.D., Pharma Research and Early Development (pRED), Roche
\n
Poster Session I, Wednesday, September 10, 6:15-7:45 p.m. CET
\n
WCBP abstracts may be accessed online here<\/a>.<\/p>\n

\nAbout NTX-1955<\/b><\/p>\n

\nNTX-1955 is a first-in-class GABAA<\/sub> \u03b31 positive allosteric modulator (PAM). Newleos licensed NTX-1955 from Roche and is conducting two Phase 1b studies in the European Union (EU) to assess the pharmacology and proof-of-mechanism for NTX-1955 in Generalized Anxiety Disorder (GAD). GABAA<\/sub> is the major inhibitory neurotransmitter in the brain and positive allosteric modulation of the GABAA<\/sub> receptor is a well-validated approach for managing GAD symptoms. Nonselective GABAA<\/sub> PAMs such as benzodiazepines, while robust anxiolytics, modulate GABAA<\/sub> receptors throughout the entire brain, including in brain regions that lead to cognitive and sedative side effects. In contrast, NTX-1955 is designed to selectively engage GABAergic transmission in the amygdala, which is at the center of the brain\u2019s regulation of anxiety and highly enriched for the GABAA<\/sub> \u03b31 receptor subunit, thereby sparing brain networks associated with the safety liabilities of benzodiazepines.<\/p>\n

\nNTX-1955 has shown dose-dependent anxiolytic activity in several gold-standard preclinical models used in anxiety research matching benzodiazepines\u2019 efficacy without the side effect profile seen with classical benzodiazepines. Further, NTX-1955 has completed multiple Phase 1 studies, including Single Ascending Dose, Multiple Ascending Dose, drug-drug interaction, and receptor occupancy studies, demonstrating that it is safe, well tolerated, brain penetrant and selective to GABAA<\/sub> \u03b31.<\/p>\n

\nIn July 2025, Newleos announced the filing of clinical trial applications (CTAs) with the competent health authorities for two Phase 1b studies of NTX-1955 to be conducted in the European Union (EU). Dosing has already commenced for one of the studies. Both studies will utilize a well-established, controlled, and reproducible clinical model to assess the anxiolytic effects of NTX-1955, as well as other tests designed to measure a wide range of central nervous system (CNS) effects in a pharmacological context.<\/p>\n

\nAbout Newleos Therapeutics, Inc.<\/b><\/p>\n

\nNewleos Therapeutics is dedicated to providing a new dawn or “eos” for the one in every eight people around the world who are suffering from mental illness. The company\u2019s pipeline was licensed from Roche and focuses on innovative neuropsychiatric mechanisms of action that aim to reduce side effects and improve outcomes compared to the current standard of care. Newleos\u2019 clinical-stage, oral small molecules target GABAA<\/sub>-\u03b31, V1a, TAAR1 and GABAA<\/sub>-\u03b15, with first- or best-in-class potential in the treatment of general anxiety, social anxiety, substance use disorders, and cognitive impairment. Newleos was co-founded by Longwood Fund, Federico Bolognani, M.D., Ph.D., and William Martin, Ph.D., seasoned experts in company creation and CNS drug development.<\/p>\n

\nFor more information visit www.newleos.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia:
\n
Kari Watson
\n
617-470-8388
\n
media@newleos.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u2013 Results of preclinical studies on selective GABAA \u03b31 positive allosteric modulators (PAMs) in anxiety models support further clinical development of NTX-1955 \u2013 BOSTON–(BUSINESS WIRE)–#AnxietyDisorders—Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the presentation of a poster related to the company\u2019s first-in-class GABAA \u03b31 positive allosteric modulator (PAM), … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61836","6":"format-standard","7":"category-industry"},"yoast_head":"\nNewleos Therapeutics Announces Poster Presentation to be Featured at the 2025 World Congress of Biological Psychiatry - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/newleos-therapeutics-announces-poster-presentation-to-be-featured-at-the-2025-world-congress-of-biological-psychiatry\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Newleos Therapeutics Announces Poster Presentation to be Featured at the 2025 World Congress of Biological Psychiatry - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u2013 Results of preclinical studies on selective GABAA \u03b31 positive allosteric modulators (PAMs) in anxiety models support further clinical development of NTX-1955 \u2013 BOSTON–(BUSINESS WIRE)–#AnxietyDisorders—Newleos Therapeutics, Inc., a clinical-stage biotechnology company developing innovative treatments for neuropsychiatric disorders, today announced the presentation of a poster related to the company\u2019s first-in-class GABAA \u03b31 positive allosteric modulator (PAM), ... 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