Actinogen randomizes first US participant in XanaMIA phase 2b/3 Alzheimer's disease trial
* Late-stage trial in Alzheimer's opens 10 sites in US, with results due in 2025 and 2026 * Appoints US-based Chief Commercial Officer, Andrew Udell * Xanamem's unique ability to control brain cortisol draws widespread coverage in the Australian media. SYDNEY, Dec. 9, 2024 /PRNewswire/ -- A...
Actinogen announces further positive results on depression in the XanCIDD phase 2a trial
Durable benefits previously reported for the MADRS depression scale are supported by the patient-reported outcome of PGI-S and new MADRS responder analyses that underscore benefit at week 10 with a 50% higher rate of remission of depression SYDNEY, Aug. 26, 2024 /PRNewswire/ -- Actinogen Medic...
Actinogen announces achievement of clinically and statistically significant superiority of Xanamem® over placebo on depression in XanaCIDD phase 2a trial
There was a clinically meaningful and persistent improvement depression measured by the key secondary endpoint of MADRS.[1] The primary endpoint of superiority to placebo in a cognitive "attention composite" of three Cogstate computerized tests was not met with large improvements seen in both Xan...
Positive Xanamem® biomarker trial published in the Journal of Alzheimer's Disease demonstrating potential Xanamem efficacy in patients with elevated blood pTau
The prospectively defined, double-blind analysis of biomarker-positive patients with mild Alzheimer's disease showed more rapid clinical progression in biomarker-positive patients, highlighting the suitability of elevated pTau for selecting patients in the on-going XanaMIA phase2b trial SYDNEY, ...
Enrolment completed in Actinogen's XanaCIDD phase 2a cognition & depression trial
Trial results anticipated in early Q3 this year SYDNEY, April 22, 2024 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) announces the full enrolment of 167 participants in the Company's XanaCIDD phase 2a clinical trial in patients with cognitive impairment in major depressive disorder (MDD)....
First patient treated in Actinogen's XanaMIA phase 2b Alzheimer's disease trial
Plus, Actinogen receives approval of its application for a UK Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for Xanamem in the treatment of Alzheimer's disease Enrolment in XanaCIDD phase 2a trial of cognitive impairment and depression has surpassed 90% SYDNE...
Positive Xanamem® human PET study published in the Journal of Alzheimer's Disease demonstrating robust CNS[1] target enzyme occupancy
The study confirms that Xanamem is a brain-penetrant inhibitor of the tissue cortisol synthesis enzyme, 11β-HSD1, with high levels of target occupancy at doses as low as 5 mg SYDNEY, Jan. 24, 2024 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) announces that its human Positron Emission Tom...
Actinogen XanaCIDD Phase 2a trial in patients with depression and cognitive impairment: enrolment accelerating and on track for results in second quarter of 2024
US$3.2 million (A$4.8m) R&D tax incentive rebate received from Australian Tax Office and XanaMIA Phase2b Alzheimer's disease trial to commence shortly with initial results expected in first half of 2025 SYDNEY, Nov. 28, 2023 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) announces that e...
Actinogen to present progress on Phase 2 trials at the BIO Investor Forum, San Francisco and Clinical Trials on Alzheimer's Disease (CTAD) Conference, Boston
Xanamem® is an oral, brain-penetrant tissue cortisol synthesis inhibitor that has shown promising safety and clinical activity in three placebo-controlled trials and has the potential to treat a variety of neurodegenerative and neuropsychiatric diseases SYDNEY, Oct. 13, 2023 /PRNewswire/ -- Acti...
Actinogen optimizes XanaMIA Phase 2b Alzheimer's disease trial design and provides general business update
Highlights Changes to the XanaMIA protocol reduce cost by AUD 30 million over the next two years and speed time to initial results while preserving the 36-week design and trial endpoints. UK sites added to the XanaCIDD trial of cognitive impairment associated with depression, due to report resu...
Actinogen to present progress on Cognitive Impairment in Depression and Alzheimer's Disease Phase 2 trials at the BIO International Convention
Xanamem® is an oral, brain-penetrant tissue cortisol synthesis inhibitor that has shown promising safety and clinical activity in three placebo-controlled trials and has the potential to treat a variety of neurodegenerative and neuropsychiatric diseases SYDNEY, May 31, 2023 /PRNewswire/ -- Actin...
Actinogen presents positive Phase 2a Xanamem data in at ADPD™ Alzheimer's and Parkinson's diseases conference
A longitudinal dataset indicating the utility of plasma pTau for patient selection in clinical trials of patients with mild Alzheimer's Disease (AD) and the likely therapeutic benefit of oral Xanamem in this population SYDNEY, March 30, 2023 /PRNewswire/ -- Actinogen Medical ASX: ACW ("ACW" or "...
FDA agrees to Actinogen six-month Phase 2b Alzheimer's Disease trial
Exploring Xanamem® and the "cortisol hypothesis" for more than 6 million Americans suffering from Alzheimer's Disease[1] SYDNEY, Dec. 22, 2022 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) is pleased to announce receipt today of agreement from the US Food and Drug Administration (FDA) to...
Actinogen announces first patient treated in depression and cognitive impairment Phase 2 clinical trial
Approximately 5% of Americans suffer from Major Depressive Disorder (MDD),[1] which is commonly associated with "foggy thinking" but a new clinical trial raises hope that once-a-day oral drug Xanamem® may assist where treatment by anti-depressant medication alone is inadequate SYDNEY, Dec. 14, 2...
Actinogen Medical Limited (ACW) announces large Xanamem® therapeutic effect in early-stage Alzheimer's Disease (AD) patients
Clinical Dementia Rating Scale - Sum of Boxes effect of 0.6 to 0.8 points observed in patients with elevated pTau biomarker with once daily, 10 mg, oral therapy SYDNEY, Oct. 10, 2022 /PRNewswire/ -- Actinogen Medical Limited (ASX: ACW) today announces positive Phase 2a clinical data from its Alz...
