{"success":true,"data":{"pressRelease":{"id":"74884","rtpr_id":"nPn9WXt0ka","ticker":"AVE","exchange":"ASX","all_tickers":["AVE"],"title":"Positive interim analysis advances Avecho Phase III insomnia program","author":"PR Newswire","published_at":"2026-06-29T07:58:53.621Z","article_body":"Positive interim analysis advances Avecho Phase III insomnia program\n\nPR Newswire\n\nMELBOURNE, Australia, June 29, 2026\n\nMELBOURNE, Australia, June 29, 2026 /PRNewswire/ -- Avecho Biotechnology\nLimited (ASX: AVE) (\"Avecho\" or \"the Company\") has announced it will continue\nwith recruitment for its world-first Phase III insomnia program following a\npositive interim analysis evaluating its TPM(®)-enhanced cannabidiol (CBD)\ncapsule.\n\nThe interim analysis represents a major value-inflection point for the\nprogram, reducing clinical development risk and providing a defined pathway\ntoward completion of the pivotal study.\n\nThe independent Data Monitoring Board (DMB) has completed its review of the\nunblinded interim analysis data from the pivotal Phase III clinical trial. The\nDMB is comprised of independent experts in sleep medicine, clinical safety and\nbiostatistics and is the only body with access to unblinded trial data.\n\nThe DMB has unanimously recommended the trial continue to the full planned\nenrolment of 519 participants. The recommendation is highly encouraging as it\nconfirms the study has satisfied the pre-specified criteria established in the\ntrial protocol to progress beyond the interim analysis and continue\nrecruitment of a second patient cohort.\n\nAvecho CEO Dr Paul Gavin said: \"This is an important and major milestone for\nAvecho, and exactly the outcome we designed this trial to achieve. We have\nalways said the trial's design - its two independent endpoints, stringent\ninclusion and exclusion criteria, and controls on the placebo effect - was its\ngreatest strength in giving the product the best chance to show its effect,\nand the positive DMB recommendation vindicates that approach.\n\n\"Although we remain blinded and the study is not complete, so final outcomes\ncannot be determined until then, we are more confident than ever that our CBD\ncapsule works as a treatment for insomnia.\"\n\nThe interim analysis was conducted on data from 244 participants randomised\nacross three treatment groups receiving nightly doses of either 150mg CBD,\n75mg CBD or placebo in a TPM®-enhanced capsule over an eight-week treatment\nperiod.\n\nSafety data reviewed at the interim analysis further supported the program,\nwith no serious adverse events (SAEs) recorded across the 244 participants.\nTolerability is central to the commercial rationale for the product.\n\nAvecho CEO Dr Paul Gavin added: \"Our focus is now shifting toward\ncommercialisation, and how this product is positioned against the medicines\npeople currently rely on for sleep. Many existing prescription treatments\ncarry well-documented limitations, including next-day impairment and the risk\nof overdose - concerns that cannabidiol's safety profile does not share.\n\n\"A treatment that can improve sleep without that safety burden has a clear\nplace in the market and will be central to our ongoing licensing discussions.\"\n\nAbout Avecho's Phase III Trial Program\n\nThe Company is currently conducting a pivotal (Phase III), multi-centre,\nrandomised, double-blind, placebo-controlled clinical trial evaluating the\nefficacy and safety of CBD TPM soft-gel capsules in adults for use in the\nreduction of insomnia severity.\n\nThe trial is the largest of its kind testing cannabidiol, taking place at\nmultiple sites around Australia. Aided by advice from international sleep and\nregulatory experts, the trial has been designed to meet the requirements of\nthe Australian Therapeutic Goods Administration (\"TGA\"), US Food and Drug\nAgency and the European Medicines Agency.\n\nTrial Participants will be randomly assigned to one of three groups to receive\nnightly doses of either 75mg or 150mg of CBD, or a placebo for eight weeks.\nParticipants will use validated questionnaires and daily sleep diaries over\nthe course of the study to record the duration and quality of their sleep.\n\nFurther information about the study can be found at ClinicalTrials.gov (Study\nIdentifier: NCT05840822).\n\nRegulatory and Commercial Progress\n\nIn 2025, Avecho licensed Australian commercial rights to the CBD TPM capsule\nto Sandoz under an agreement that included a US$3 million upfront payment,\npotential development and commercial milestones of up to US$16 million and\ntiered royalties on future sales.([1])\n\nThe positive interim analysis strengthens Avecho's commercial position and\nadds momentum to ongoing licensing discussions covering territories outside\nAustralia.\n\nThe Company believes the interim outcome enhances the attractiveness of the\nprogram to potential commercial partners and strengthens the product's\npositioning against existing sleep medications. Accordingly, progressing\nadditional regional licensing agreements will be a key strategic priority as\nAvecho seeks to fund continued development while maximising shareholder value.\n\nThe Company will also now look to engage with the FDA and other international\nregulatory agencies to determine the path forward for the product in specific\ngeographies.\n\n([1]) https://announcements.asx.com.au/asxpdf/20250303/pdf/06g5xlzjwc3h7z.pdf\n(https://protect.checkpoint.com/v2/r04/___https://announcements.asx.com.au/asxpdf/20250303/pdf/06g5xlzjwc3h7z.pdf___.Y3A0YTphdmVjaG86YzpvZmZpY2UzNjVfZW1haWxzX2F0dGFjaG1lbnQ6N2IyYjRiNmE3MTNiOGQyMDQ3NWZjYTY2ZTUyMmE2ZDI6NzoxNTYxOjUwMTJlNjM5NjM3ZmI1NGM2OGZkNWY1MjUyODcxN2E3YjdkYjNhYTg2YmE4NDQ5NjUwNGUwMzYxMzMxMWZiZDc6cDpUOk4)\n\nView original\ncontent:https://www.prnewswire.com/news-releases/positive-interim-analysis-advances-avecho-phase-iii-insomnia-program-302813008.html\n(https://www.prnewswire.com/news-releases/positive-interim-analysis-advances-avecho-phase-iii-insomnia-program-302813008.html)\n\nSOURCE Avecho Biotechnology Limited\n\n\n\nFor enquiries, please contact: H^CK Director, Haley Chartres, haley@hackhq.com.au, +61 423 139 163\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn9WXt0ka","title":"Positive interim analysis advances Avecho Phase III insomnia program","author":"PR Newswire","ticker":"AVE","created":"2026-06-29T07:58:53.621Z","tickers":["AVE"],"exchange":"ASX","article_body":"Positive interim analysis advances Avecho Phase III insomnia program\n\nPR Newswire\n\nMELBOURNE, Australia, June 29, 2026\n\nMELBOURNE, Australia, June 29, 2026 /PRNewswire/ -- Avecho Biotechnology\nLimited (ASX: AVE) (\"Avecho\" or \"the Company\") has announced it will continue\nwith recruitment for its world-first Phase III insomnia program following a\npositive interim analysis evaluating its TPM(®)-enhanced cannabidiol (CBD)\ncapsule.\n\nThe interim analysis represents a major value-inflection point for the\nprogram, reducing clinical development risk and providing a defined pathway\ntoward completion of the pivotal study.\n\nThe independent Data Monitoring Board (DMB) has completed its review of the\nunblinded interim analysis data from the pivotal Phase III clinical trial. The\nDMB is comprised of independent experts in sleep medicine, clinical safety and\nbiostatistics and is the only body with access to unblinded trial data.\n\nThe DMB has unanimously recommended the trial continue to the full planned\nenrolment of 519 participants. The recommendation is highly encouraging as it\nconfirms the study has satisfied the pre-specified criteria established in the\ntrial protocol to progress beyond the interim analysis and continue\nrecruitment of a second patient cohort.\n\nAvecho CEO Dr Paul Gavin said: \"This is an important and major milestone for\nAvecho, and exactly the outcome we designed this trial to achieve. We have\nalways said the trial's design - its two independent endpoints, stringent\ninclusion and exclusion criteria, and controls on the placebo effect - was its\ngreatest strength in giving the product the best chance to show its effect,\nand the positive DMB recommendation vindicates that approach.\n\n\"Although we remain blinded and the study is not complete, so final outcomes\ncannot be determined until then, we are more confident than ever that our CBD\ncapsule works as a treatment for insomnia.\"\n\nThe interim analysis was conducted on data from 244 participants randomised\nacross three treatment groups receiving nightly doses of either 150mg CBD,\n75mg CBD or placebo in a TPM®-enhanced capsule over an eight-week treatment\nperiod.\n\nSafety data reviewed at the interim analysis further supported the program,\nwith no serious adverse events (SAEs) recorded across the 244 participants.\nTolerability is central to the commercial rationale for the product.\n\nAvecho CEO Dr Paul Gavin added: \"Our focus is now shifting toward\ncommercialisation, and how this product is positioned against the medicines\npeople currently rely on for sleep. Many existing prescription treatments\ncarry well-documented limitations, including next-day impairment and the risk\nof overdose - concerns that cannabidiol's safety profile does not share.\n\n\"A treatment that can improve sleep without that safety burden has a clear\nplace in the market and will be central to our ongoing licensing discussions.\"\n\nAbout Avecho's Phase III Trial Program\n\nThe Company is currently conducting a pivotal (Phase III), multi-centre,\nrandomised, double-blind, placebo-controlled clinical trial evaluating the\nefficacy and safety of CBD TPM soft-gel capsules in adults for use in the\nreduction of insomnia severity.\n\nThe trial is the largest of its kind testing cannabidiol, taking place at\nmultiple sites around Australia. Aided by advice from international sleep and\nregulatory experts, the trial has been designed to meet the requirements of\nthe Australian Therapeutic Goods Administration (\"TGA\"), US Food and Drug\nAgency and the European Medicines Agency.\n\nTrial Participants will be randomly assigned to one of three groups to receive\nnightly doses of either 75mg or 150mg of CBD, or a placebo for eight weeks.\nParticipants will use validated questionnaires and daily sleep diaries over\nthe course of the study to record the duration and quality of their sleep.\n\nFurther information about the study can be found at ClinicalTrials.gov (Study\nIdentifier: NCT05840822).\n\nRegulatory and Commercial Progress\n\nIn 2025, Avecho licensed Australian commercial rights to the CBD TPM capsule\nto Sandoz under an agreement that included a US$3 million upfront payment,\npotential development and commercial milestones of up to US$16 million and\ntiered royalties on future sales.([1])\n\nThe positive interim analysis strengthens Avecho's commercial position and\nadds momentum to ongoing licensing discussions covering territories outside\nAustralia.\n\nThe Company believes the interim outcome enhances the attractiveness of the\nprogram to potential commercial partners and strengthens the product's\npositioning against existing sleep medications. Accordingly, progressing\nadditional regional licensing agreements will be a key strategic priority as\nAvecho seeks to fund continued development while maximising shareholder value.\n\nThe Company will also now look to engage with the FDA and other international\nregulatory agencies to determine the path forward for the product in specific\ngeographies.\n\n([1]) https://announcements.asx.com.au/asxpdf/20250303/pdf/06g5xlzjwc3h7z.pdf\n(https://protect.checkpoint.com/v2/r04/___https://announcements.asx.com.au/asxpdf/20250303/pdf/06g5xlzjwc3h7z.pdf___.Y3A0YTphdmVjaG86YzpvZmZpY2UzNjVfZW1haWxzX2F0dGFjaG1lbnQ6N2IyYjRiNmE3MTNiOGQyMDQ3NWZjYTY2ZTUyMmE2ZDI6NzoxNTYxOjUwMTJlNjM5NjM3ZmI1NGM2OGZkNWY1MjUyODcxN2E3YjdkYjNhYTg2YmE4NDQ5NjUwNGUwMzYxMzMxMWZiZDc6cDpUOk4)\n\nView original\ncontent:https://www.prnewswire.com/news-releases/positive-interim-analysis-advances-avecho-phase-iii-insomnia-program-302813008.html\n(https://www.prnewswire.com/news-releases/positive-interim-analysis-advances-avecho-phase-iii-insomnia-program-302813008.html)\n\nSOURCE Avecho Biotechnology Limited\n\n\n\nFor enquiries, please contact: H^CK Director, Haley Chartres, haley@hackhq.com.au, +61 423 139 163\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-06-29T07:58:53.668846441Z","server_sent_at_ms":1782719933668},"received_at":"2026-06-29T07:58:53.736Z","source_url":"https://www.prnewswire.com/news-releases/positive-interim-analysis-advances-avecho-phase-iii-insomnia-program-302813008.html"},"analysis":{"id":"64242","press_release_id":"74884","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Avecho announced a positive interim analysis for its pivotal Phase III insomnia trial, with the independent Data Monitoring Board unanimously recommending continuation to the full planned enrollment of 519 participants.\n\nThe interim data from 244 participants showed no serious adverse events, supporting the safety profile of the TPM-enhanced CBD capsule across 150mg and 75mg doses over an eight-week period.\n\nThis milestone de-risks the clinical program and strengthens Avecho's position in ongoing licensing discussions for territories outside Australia, where it already holds a deal with Sandoz for Australian rights.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Pivotal Phase III insomnia trial hits positive interim milestone; DMB recommends full enrollment, boosting licensing prospects."},"keyFigures":{"drugName":"TPM-enhanced cannabidiol (CBD) capsule","phaseOfTrial":"Phase III","customDimensions":{"doses_tested":["150mg CBD","75mg CBD","placebo"],"interim_participants":244,"sandoz_milestones_usd":16000000,"serious_adverse_events":0,"total_enrollment_target":519,"treatment_duration_weeks":8,"sandoz_upfront_payment_usd":3000000}},"quotedText":"This is an important and major milestone for Avecho, and exactly the outcome we designed this trial to achieve.","namedEntities":{"people":[{"name":"Dr Paul Gavin","role":"CEO"},{"name":"Haley Chartres","role":"H^CK Director"}],"products":["TPM-enhanced cannabidiol (CBD) capsule","CBD TPM soft-gel capsules"],"companies":[{"name":"Avecho Biotechnology Limited","ticker":"AVE","relationship":"filer"},{"name":"Sandoz","relationship":"licensing partner (Australia)"},{"name":"H^CK","relationship":"PR agency"}],"dollarAmounts":[{"amount":"US$3 million","context":"upfront payment from Sandoz for Australian commercial rights"},{"amount":"US$16 million","context":"potential development and commercial milestones from Sandoz"}]},"materialImpact":{"score":4,"reasoning":"Positive interim analysis in a pivotal Phase III trial for the company's lead asset, with a unanimous Data Monitoring Board recommendation to continue recruitment. This de-risks the program significantly and supports ongoing licensing discussions, though final efficacy data is still pending."},"tickerRelevance":{"others":[{"ticker":"SANDOZ","relevance":"licensing partner"}],"primary":"AVE"},"globalImportance":35,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"positive_interim_phase3","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"low","retailFavoriteBoost":0}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Avecho announced a positive interim analysis for its pivotal Phase III insomnia trial, with the independent Data Monitoring Board unanimously recommending continuation to the full planned enrollment of 519 participants.\n\nThe interim data from 244 participants showed no serious adverse events, supporting the safety profile of the TPM-enhanced CBD capsule across 150mg and 75mg doses over an eight-week period.\n\nThis milestone de-risks the clinical program and strengthens Avecho's position in ongoing licensing discussions for territories outside Australia, where it already holds a deal with Sandoz for Australian rights.","key_figures":{"drugName":"TPM-enhanced cannabidiol (CBD) capsule","phaseOfTrial":"Phase III","customDimensions":{"doses_tested":["150mg CBD","75mg CBD","placebo"],"interim_participants":244,"sandoz_milestones_usd":16000000,"serious_adverse_events":0,"total_enrollment_target":519,"treatment_duration_weeks":8,"sandoz_upfront_payment_usd":3000000}},"named_entities":{"people":[{"name":"Dr Paul Gavin","role":"CEO"},{"name":"Haley Chartres","role":"H^CK Director"}],"products":["TPM-enhanced cannabidiol (CBD) capsule","CBD TPM soft-gel capsules"],"companies":[{"name":"Avecho Biotechnology Limited","ticker":"AVE","relationship":"filer"},{"name":"Sandoz","relationship":"licensing partner (Australia)"},{"name":"H^CK","relationship":"PR agency"}],"dollarAmounts":[{"amount":"US$3 million","context":"upfront payment from Sandoz for Australian commercial rights"},{"amount":"US$16 million","context":"potential development and commercial milestones from Sandoz"}]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-29T07:59:05.300Z","global_importance":35,"audience_relevance":25,"importance_components":{"tickerTier":"small-cap","eventGravity":"positive_interim_phase3","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"low","retailFavoriteBoost":0}},"durationMs":11549,"modelName":"george-droid-qwen-72b"}}