{"id":60726,"date":"2025-02-04T07:02:50","date_gmt":"2025-02-04T06:02:50","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/algiax-announces-positive-data-from-phase-2a-proof-of-concept-study-evaluating-ap-325-in-patients-with-neuropathic-pain\/"},"modified":"2025-02-04T07:02:50","modified_gmt":"2025-02-04T06:02:50","slug":"algiax-announces-positive-data-from-phase-2a-proof-of-concept-study-evaluating-ap-325-in-patients-with-neuropathic-pain","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/algiax-announces-positive-data-from-phase-2a-proof-of-concept-study-evaluating-ap-325-in-patients-with-neuropathic-pain\/","title":{"rendered":"Algiax Announces Positive Data from Phase 2a Proof of Concept Study Evaluating AP-325 in Patients with Neuropathic Pain"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nAllosteric GABA<sub>A<\/sub>-receptor modulator AP-325 showed rapid onset as well as long-lasting pain reduction in patients with chronic neuropathic pain in Phase 2a study<\/li>\n<li>\nData confirm previously reported good safety and tolerability with comparable side effects profile as placebo and no central symptoms like sedation, drowsiness and dizziness<\/li>\n<li>\nTreatment further improved key quality of life markers including sleep interference, anxiety and depression symptoms<\/li>\n<li>\nCompany to explore opportunities to support rapid advancement of AP-325\u2019s clinical development<\/li>\n<\/ul>\n<p>D\u00dcSSELDORF, Germany&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.algiax.com%2F&amp;esheet=54198212&amp;newsitemid=20250203838341&amp;lan=en-US&amp;anchor=Algiax+Pharmaceuticals&amp;index=1&amp;md5=20fab15db445d2d17ba0ab076c9a2586\" rel=\"nofollow\" shape=\"rect\">Algiax Pharmaceuticals<\/a>, a clinical-stage biotech company focused on developing innovative treatments for chronic neuropathic pain, today announced compelling topline data from its Phase 2a clinical trial evaluating AP-325 for the treatment of neuropathic pain. The study demonstrated that the company\u2019s lead candidate has the potential to rapidly reduce neuropathic pain as well as achieve long-lasting benefits for patients post treatment. AP-325 is a non-opioid small molecule aimed at reducing neuropathic pain by activating GABA<sub>A<\/sub> signalling. Neuropathic pain is a chronic condition that is oftentimes associated with an imbalance in excitatory and inhibitory neuronal signals. By consistently counteracting the excessive activation of neurons, AP-325 has the potential to revolutionize neuropathic pain management.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250203838341\/en\/2370459\/5\/logo-algiax-pharmaceuticals-768x248.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250203838341\/en\/2370459\/22\/logo-algiax-pharmaceuticals-768x248.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250203838341\/en\/2370459\/5\/logo-algiax-pharmaceuticals-768x248.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250203838341\/en\/2370459\/21\/logo-algiax-pharmaceuticals-768x248.jpg\"><\/a><\/p>\n<p>\n\u201cThese results mark a significant step towards our vision of disarming chronic neuropathic pain and offering a well-tolerated treatment option without the risk of dependence to patients suffering from this debilitating condition,\u201c commented Dr. Ingo Lehrke, CEO of Algiax Pharmaceuticals. \u201cBased on these highly encouraging results, we are exploring the best path forward to rapidly deliver the benefits of AP-325 to patients suffering from chronic pain worldwide and improve their quality of life.\u201d<\/p>\n<p>\n<b>Key findings from the Phase 2a study with AP-325 include:<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nRapid onset of action resulting in clinically meaningful pain reduction in Pain Intensity Numeric Rating Scale (PI-NRS) within less than two weeks of treatment<\/li>\n<li>\nTreatment effects remained persistent after initial treatment period, suggesting a potential lasting disease modification<\/li>\n<li>\nHigh responder rate: the \u226550% and \u226570% patient responder rates were significantly higher compared to placebo with AP-325 treatment. At the end of study, over a quarter of the AP-325 treated patients showed a pain reduction of \u226550% compared to 11% of the placebo treated patients.<\/li>\n<li>\nMore than half of patients in the AP-325 cohort did not need to use rescue medication compared to only 21% in the placebo group<\/li>\n<li>\nNumber needed to treat (NNT) for AP-325, a key measure to analyze treatment success, compares favourably to current standard of care and demonstrates AP-325 achieves similar outcomes as opioid-based drugs without the associated safety concerns<\/li>\n<li>\nSignificant improvement in sleep quality and reduction in anxiety and depression scores<\/li>\n<li>\nGood safety profile with observed side effects comparable to placebo and no central side effects including sedation, drowsiness or dizziness<\/li>\n<\/ul>\n<p>\nDr. Guido Koopmans, CSO of Algiax Pharmaceuticals, added, \u201cWith a lack of non-opioid treatment options for chronic neuropathic pain, there is a remaining high need for millions of patients worldwide. The clinical meaningful effects in our Phase 2a study, combined with the clean safety profile, in particular regarding central nervous system side effects seen with standard of care, underline AP-325\u2019s unique potential to provide a paradigm shift in neuropathic pain management for patients.\u201d<\/p>\n<p>\nThe Phase 2a randomized, double-blinded, placebo-controlled trial evaluated the safety and efficacy of AP-325 as a monotherapy in patients with peripheral post-surgical neuropathic pain. The study enrolled 99 participants in Germany, Spain, the Czech Republic, Belgium, and France at a total of 27 sites.<\/p>\n<p>\n<b>About Algiax<\/b><\/p>\n<p>\nAlgiax Pharmaceuticals is dedicated to providing better long-lasting treatment options for neuropathic pain alleviating the burden of this chronic condition by modulating GABA<sub>A <\/sub>signaling. Its lead small-molecule candidate AP-325 is currently being investigated in a Phase 2 study and has already demonstrated a good safety profile and encouraging efficacy with disease modifying potential in early clinical and preclinical evaluations. The company aims to further explore the potential of GABA<sub>A<\/sub> modulation through its proprietary Thioacrylamide (ThAc) derivatives as follow-up candidates for neuropathic pain.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>For more information, please contact:<\/b><br \/>Algiax Pharmaceuticals GmbH<br \/>\n<br \/>Ingo Lehrke, CEO<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;&#x74;&#111;&#x3a;&#x69;n&#x66;&#111;&#x40;&#97;&#x6c;&#103;i&#x61;&#120;&#x2e;&#99;&#x6f;&#109;\" rel=\"nofollow\" shape=\"rect\">&#105;&#x6e;&#x66;o&#64;&#x61;&#x6c;g&#105;&#x61;x&#46;&#x63;&#x6f;m<\/a><\/p>\n<p>\n<b>For media requests<\/b><br \/>Trophic Communications<br \/>\n<br \/>Stephanie May<br \/>\n<br \/>Phone: +49 171 1855682<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;&#x69;&#x6c;t&#x6f;&#58;a&#x6c;&#103;i&#x61;&#120;&#x40;&#x74;r&#x6f;&#112;h&#x69;&#99;&#46;&#x65;&#117;\" rel=\"nofollow\" shape=\"rect\">&#97;&#x6c;g&#105;&#x61;x&#64;&#x74;r&#x6f;&#x70;&#104;&#x69;c&#46;&#x65;u<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Allosteric GABAA-receptor modulator AP-325 showed rapid onset as well as long-lasting pain reduction in patients with chronic neuropathic pain in Phase 2a study Data confirm previously reported good safety and tolerability with comparable side effects profile as placebo and no central symptoms like sedation, drowsiness and dizziness Treatment further improved key quality of life markers &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/algiax-announces-positive-data-from-phase-2a-proof-of-concept-study-evaluating-ap-325-in-patients-with-neuropathic-pain\/\">[Read more&#8230;]<\/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-60726","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Algiax Announces Positive Data from Phase 2a Proof of Concept Study Evaluating AP-325 in Patients with Neuropathic Pain - 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\/algiax-announces-positive-data-from-phase-2a-proof-of-concept-study-evaluating-ap-325-in-patients-with-neuropathic-pain\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Algiax Announces Positive Data from Phase 2a Proof of Concept Study Evaluating AP-325 in Patients with Neuropathic Pain - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Allosteric GABAA-receptor modulator AP-325 showed rapid onset as well as long-lasting pain reduction in patients with chronic neuropathic pain in Phase 2a study Data confirm previously reported good safety and tolerability with comparable side effects profile as placebo and no central symptoms like sedation, drowsiness and dizziness Treatment further improved key quality of life markers ... 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