Clinical Development Pipeline
The Xanamem® Pipeline
Diseases to be studied
Phase 2 placebo-controlled trials
Outlook
Biomarker analysis in patients with mild AD
Cognitive benefit in patients with early stages of AD
Pivotal trials focused on cognitive enhancement
Diseases to be studied
Phase 2 placebo-controlled trials
Outlook
Depression and cognitive impairment
Pivotal trials assessing both depression and cognitive impairment
Diseases to be studied
Phase 2 placebo-controlled trials
Outlook
Proof of concept in adolescent and young adult males
Pending alternative funding e.g. partnerships or grants
Alzheimer's Disease
Alzheimer’s Disease is a chronic degenerative condition of the brain affecting more than 50 million people worldwide. It leads to gradual or rapid loss of cognitive ability i.e. the ability to perform tasks, think and remember clearly.
Find out more Participate in trialMajor Depressive Disorder
Depression is one of the most common and burdensome psychiatric disorders worldwide, with an estimated 5% of the population affected. Depression is a complex disease characterized by emotional, physical and cognitive symptoms. Persons with depression often experience impairment in cognitive function in several domains, including executive functioning, processing speed, concentration/attention, learning, and memory not only before and during depressive episodes but also after remission of mood symptoms.
Higher levels of cortisol have been associated with severity of depressive symptoms, suggesting a possible therapeutic role for Xanamem to lower cortisol in the brain. Attempts to modify cortisol signaling in the brain via other mechanisms have met with mixed results for depression.
Find out moreFragile X Syndrome
Fragile X Syndrome (FXS) is the most common inherited cause of autism and intellectual disabilities worldwide. It is a life-long genetic disorder caused by alterations in the Fragile X gene (FMR1) that cause the brain to fail to develop as it should. The syndrome usually affects males more seriously than females. Persons affected have issues with autism symptoms, anxiety, difficulty thinking and concentrating, and “sensory overload”.
Find out morePatient Portal
All of our clinical trials are registered with clinicaltrials.gov, a regulated website that is managed and overseen by the US Food and Drug Administration (FDA).
The Actinogen phase 2b/3 Alzheimer's disease trial is now recruiting
Completed Clinical Trials
To find out more about our completed Phase 2a trial of Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD) (NCT05657691), please click here.
To find out more about our completed Phase 1b XanaMIA-DR study in Healthy Elderly Volunteers (NCT04983368), please click here.
To find out more about our completed Phase 2 XanADu study in Mild Alzheimer’s Disease Patients (NCT02727699), please click here.
To find out more about our completed Phase 1 XanaHES study in Healthy Elderly Volunteers (NCT03830762), please click here.
To find out more about our completed Phase 1 Multiple Ascending Dose in Healthy Volunteers (MAD) study (NCT02616445), please click here.
To find out more about our completed Phase 1 Single Ascending Dose (SAD) study in Healthy Volunteers (NCT01770886), please click here.
Contact Us
If you have any enquiries regarding our trials please reach out to us at clinicaltrials@actinogen.com.au.
Publications
Dana Hilt, Jack Taylor, Mark Jaros, Christopher Li-Hsian Chen and John Harrison. Academic poster presented at the Clinical Trials on Alzheimer’s Disease International Conference (CTAD) 31 October 2024.
Paul Rolan, Jack Taylor, Jonathan Seckl, John Harrison, Christopher Li-Hsian Chen, Colm Farrell, Paul Maruff, Michael Woodward and Dana Hilt. Academic poster presented at the Alzheimer’s Association International Conference (AAIC) 29 July 2024.
Jack Taylor, Mark Jaros, Christopher Chen, John Harrison and Dana Hilt. Article published to the Journal of Alzheimer’s Disease 26 June 2024.
Clinical pharmacology and development of Xanamem, a tissue specific inhibitor of 11β-HSD1
Paul Rolan, Jack Taylor, Jonathan Seckl, John Harrison, Christopher Li-Hsian Chen, Colm Farrell, Paul Maruff, Michael Woodward and Dana Hilt. Academic poster presented at the Australian Dementia Research Forum (ADRF2024) on the Gold Coast, Australia from 3 to 5 June 2024.
Dana Hilt, Jack Taylor, Tamara Miller, John Harrison, Christopher Chen and Craig Ritchie. Academic poster presented at Alzheimer’s and Parkinson’s diseases conference (ADPD) 6 March 2024.
Victor L. Villemagne, Vincent Doré, Lee Chong, Michael Kassiou , Rachel Mulligan, Azadeh Feizpour , Jack Taylor, Miriam Roesner, Tamara Miller and Christopher C. Rowe. Article published to the Journal of Alzheimer’s Disease 19 January 2024.
Dana Hilt, Jack Taylor, Tamara Miller, John Harrison, Christopher Chen, Craig Ritchie. Academic poster presented to Clinical Trials on Alzheimer’s Disease (CTAD) 24 – 27 October 2023.
Dana Hilt; Jack Taylor; Paul Rolan; Tamara Miller; Mark Jaros; John Harrison; Craig Ritchie. Academic poster presented to Alzheimer’s Association International Conference 17 July 2023.
Michael Woodward; Paul Rolan; Jack Taylor; Tamara Miller; John Harrison; Dana Hilt; Paul Maruff. Academic poster presented to Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2 December 2022
Sooy, K., Noble, J., McBride, A., Binnie, M., Yau, J. L. W., Seckl, J. R., Walker, B. R., & Webster, S. P. 2015. Endocrinology, 1-12.
Scott P Webster, AndrewMcBride, Margaret Binnie, Karen Sooy, Jonathan R Seckl, Ruth Andrew, T David Pallin, Hazel J Hunt, Trevor R Perrior, Vincent S Ruffles, J William Ketelbey, Alan Boyd and Brian R Walker 2017. British Journal of Pharmacology.
Discovery and biological evaluation of adamantyl amide 11β-HSD1 inhibitors
Webster, S. P., Ward, P., Binnie, M., Craigie, E., McConnell, K. M., Sooy, K., Vinter, A., Seckl, J.R. & Walker, B. R. 2007. Bioorganic & medicinal chemistry letters, 17(10), 2838-2843.
Jonathan Seckl. Journal of Internal Medicine, 2024, 295; 20–37
Nicola Wheelan, Christopher J. Kenyon, Anjanette P. Harris, Carolynn Cairns, Emad Al Dujaili, Jonathan R. Seckl, Joyce L.W. Yau 2018. Psychoneuroendocrinology 89 (2018) 13–22.
Sandeep, T. C., Yau, J. L. W., MacLullich, A. M. J., Noble, J., Deary, I. J., Walker, B. R., & Seckl, J. R. 2004. PNAS, 101(17), 6734-6739.
Sooy, K., Noble, J., McBride, A., Binnie, M., Yau, J. L. W., Seckl, J. R., Walker, B. R., & Webster, S. P. 2015. Endocrinology, 1-12.
Sarabdjitsingh, R. A., Zhou, M., Yau, J. L., Webster, S. P., Walker, B.R., Seckl, J. R., Joëls, M., & Krugers, H. J. 2014. Neuropharmacology, 81, 231-6.
Yau, J. L., Noble, J., & Seckl, J. R. 2011. Journal of Neuroscience, 31(11), 4188 – 4193.
11β-hydroxysteroid dehydrogenase type 1, brain atrophy and cognitive decline
MacLullich, A. M. 1., Ferguson, K. J., Reid, L. M., Deary, I. J., Starr, J. M., Wardlaw, J. M., Walker, B. R., Andrew, R., & Seckl, J. R. 2012. Journal of Neurobiological Aging, 33(1), 5406-13.
Mohler, E. G., Browman, K. E., Roderwald, V. A., Cronin, E. A., Markosyan, S., Scott Bitner, R., Strakhova, M. I., Drescher, K. U., Hornberger, W., Rohde, J. J., Brune, M. E., Jacobson, P. B., & Rueter, L. E. 2011. Journal of Neuroscience, 31(4), 5406-13.
Holmes, M. C., Carter, R. N., Noble, J., Chitnis, S., Dutia, A., Paterson, J. M., Mullins, J. J., Seckl, J. R., Yau, J.L. 2010. Journal of Neuroscience, 30(20), 6916-20.
Sooy, K., Webster, S. P., Noble, J., Binnie, M., Walker, B. R., Seckl, J. R., & Yau, J. L. W. 2010. Journal of Neuroscience, 30(41), 13867-13872.
Circulating cortisol and cognitive and structural brain measures
Echouffo-Tcheugui, Justin B., Sarah C. Conner, Jayandra J. Himali, Pauline Maillard, Charles S. DeCarli, Alexa S. Beiser, Ramachandran S. Vasan, and Sudha Seshadri 2018. Neurology: 10-1212.
Robert H. Pietrzak, Simon M. Laws, Yen Ying Lim, Sophie J. Bender, Tenielle Porter, James Doecke, David Ames, Christopher Fowler, Colin L. Masters, Lidija Milicic, Stephanie Rainey-Smith, Victor L. Villemagne, Christopher C. Rowe, Ralph N. Martins, and Paul Maruff, for the Australian Imaging, Biomarkers and Lifestyle Research Group 2017. Biological Psychiatry: Cognitive Neuroscience and Neuroimaging 2(1): 45-52.
Popp, J., Wolfsgruber, S., Heuser, I., Peters, O., Hull, M., Schroder, J., Moller, H. J., Lewczuk, P., Schneider, A., Jahn, H., Luckhaus, C., Perneczky, R., Frolich, L., Wagner, M., Maier, W., Wiltfang, J., Kornhuber, J., & Jessen, F. 2015. Neurobiology of Aging, 36, 601-607.
Cortisol levels during human aging predict hippocampal atrophy and memory deficits
Lupien, S. J., de Leon, M., de Santi, S., Convit, A., Tarshish, C., Nair, N. P. V., Thakur, M., McEwen, B. S., Hauger, L., & Meaney, M. J. 1998. Nature Neuroscience, 1(1), 69-73.
Plasma cortisol and progression of dementia in subjects with Alzheimer-type dementia
Csernansky, J. G., Dong, H., Fagan, A. M., Wang, L., Xiong, C., Holtzman, D. M., & Morris, J. C. 2006. American Journal of Psychiatry, 163, 2164-2169.
Salivary cortisol, brain volumes, and cognition in community-dwelling elderly without dementia
Geerlings, M. I., Sigurdsson, S., Eiriksdottir, G., Garcia, M. E., Harris, T. B., Gudnason, V., & Launer, L. J. 2015. Neurology, 85(11), 976-983.
Plasma cortisol levels, brain volumes and cognition in healthy elderly men
MacLullich, A. M., Deary, I. J., Starr, J. M., Ferguson, K. J., Wardlaw, J. M., & Seckl, J. R. 2005. Psychoneuroendocrinology, 30(5), 505-515.
Effects of stress throughout the lifespan on the brain, behaviour and cognition
Lupien, S. J., McEwen, B. S., Gunnar, M. R., & Heim, C. 2009. Nature reviews neuroscience, 10(6), 434-445.
Decrease in cortisol reverses human hippocampal atrophy following treatment of Cushing’s disease
Starkman, M. N., Giordani, B., Gebarski, S. S., Berent, S., Schork, M. A., & Schteingart, D. E. 1999. Biological psychiatry, 46(12), 1595-1602.
Reynolds, R. M., & Webster, S. P. 2015. Neuroendocrinology of Stress, 327-350.
Glucocorticoids increase amyloid beta and tau pathology in a mouse model of Alzheimer’s Disease
Green K.N., Billings L.M., Roozendaal B. et al. 2006. J. Neurosci. 26: 9047–56.
Lehallier, B., Essioux, L., Gayan, J., Alexandridis, R., Nikolcheva, T., Wyss-Coray, T., & Britschgi, M. 2016. JAMA neurology, 73(2), 203-212.
Long-term cortisol measures predict Alzheimer Disease risk
Ennis, G. E., An, Y., Resnick, S. M., Ferrucci, L., O’brien, R. J., & Moffat, S. D. 2017. Neurology, 88(4), 371-378.
Hippocampal damage associated with prolonged glucocorticoid exposure in primates
Sapolsky RM, Uno H, Rebert CS et al. 1990. J Neurosci. 10: 2897–2902.
Environmental novelty exacerbates stress hormones and Aβ pathology in an Alzheimer’s model
Kimberley E. Stuart, Anna E. King, Carmen M. Fernandez-Martos, Mathew J. Summers & James C. Vickers 2018. Nature Scientific Reports 7: 2764.
Intellectual functioning and behavioural features associated with mosaicism in Fragile X Syndrome
Baker, E. K., Arpone, M., Vera, S. A., Bretherton, L., Ure, A., Kraan, C. M., Bui, M., Ling, L., Francis, D., Hunter, M. F., Elliott, J., Rogers, C., Field, M. J., Cohen, J., Santa Maria, L., Faundes, V., Curotto, B., Morales, P., Trigo, C., Salas, I., Alliende, A. M., Amor, D. J. & Godler, D. E. 2019. Journal of Neurodevelopmental Disorders, 11, 15.
Roberts, J. E., Ezell, J. E., Fairchild, A. J., Klusek, J., Thurman, A. J., Mcduffie, A. & Abbeduto, L. 2018. American Journal of Medical Genetics Part B-Neuropsychiatric Genetics, 177, 665-675.
Matherly, S. M., Klusek, J., Thurman, A. J., Mcduffie, A., Abbeduto, L. & Roberts, J. E. 2018. Developmental Psychobiology, 60, 78-89.
Hagerman, R. J., Berry-Kravis, E., Hazlett, H. C., Bailey, D. B., Moine, H., Kooy, R. F., Tassone, F., Gantois, I., Sonenberg, N., Mandel, J. L. & Hagerman, P. J. 2017. Nature Reviews Disease Primers, 3, 19.
HPA axis function predicts development of working memory in boys with FXS
Scherr, J. F., Hahn, L. J., Hooper, S. R., Hatton, D. & Roberts, J. E. 2016. Brain and Cognition, 102, 80-90.
Cortisol and behavior in Fragile X Syndrome
Hessl, D., Glaser, B., Dyer-Friedman, J., Blasey, C., Hastie, T., Gunnar, M. & Reiss, A. L. 2002. Psychoneuroendocrinology, 27, 855-872.
Cortisol and social stressors in children with Fragile X: A pilot study
Wisbeck, J. M., Huffman, L. C., Freund, L., Gunnar, M. R., Davis, E. P. & Reiss, A. L. 2000. Journal of Developmental and Behavioral Pediatrics, 21, 278-282.
Haley M. LaMonica, Daniel J. Biddle, Sharon L. Naismith, Ian B. Hickie, Paul Maruff, Nicholas Glozier. Journal Plos One September 5, 2018
Dodd S, Skvarc D R, Dean OM, Anderson A, Kotowicz M, Berk M 10 Feb 2022. Int J Neuropsychopharmacol. doi: 10.1093/ijnp/pyac014.
J. Conradi, J. Ormel and P. de Jonge 2011. Psychological Medicine, 41, 1165–1174.
Cinnamon Stetler, PhD, And Gregory E. Miller, PhD 2011. Psychosomatic Medicine 73:114–126.
Florian Holsboer, Marcus Ising 2008. European Journal of Pharmacology 583, 350–357
Malhi, G.S. and J.J. Mann 2018. The Lancet 392(10161): p. 2299-2312.
Unipolar major depression in adults: Choosing initial treatment
Rush, A.J 2020. UpToDate
Gorwood, P., et al., 2008. American Journal of Psychiatry 165(6): p. 731-739.
Cognitive function following a major depressive episode: a systematic review and meta-analysis
Semkovska, M., et al. 2019. The Lancet Psychiatry 6(10): p. 851-861.
Neurocognitive deficits and disability in major depressive disorder
Jaeger, J., et al. 2006. Psychiatry Res 145(1): p. 39-48.
Fischer, S., et al. 2017. Br J Psychiatry 210(2): p. 105-109.
Psychiatric symptoms in Cushing’s syndrome: A systematic review
Lin, T.Y., J. Hanna, and W.W. Ishak 2020. Innovations in Clinical Neuroscience 17(1-3): p. 30-35.
Global economic burden of schizophrenia: a systematic review
Chong, Huey Yi et al. Neuropsychiatric disease and treatment vol. 12 357-73. 16 Feb. 2016, doi:10.2147/NDT.S96649.
Bruijnzeel, D, and R Tandon. 2016. Drug Design, Development and Therapy 10: 1641-1647.
Efficacy of different types of cognitive enhancers for patients with schizophrenia: a meta-analysis
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