Actinogen Medical News - LARVOL Sigma

|||||||||| Xanamem (UE2343) / Actinogen Medical
Journal: The Importance of PET Imaging to Understanding Whole-Body Cortisol Metabolism in Alzheimer's Disease. (Pubmed Central) - Apr 12, 2024
In this current issue, high regional brain occupancy of Xanamemtrademark, determined by [11C]TARACT PET imaging of 11?-HSD1, in cognitively normal individuals and mild cognitive impartment/Alzheimer's disease (AD) patients is presented. In the future, comprehensive kinetic modeling using arterial sampling for occupancy studies, and whole-body PET imaging of 11?-HSD1 enzyme levels, in combination with stable isotope studies of cortisol metabolism, can provide broad insight into enzyme levels and activity in AD and other relevant diseases.

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Journal: Brain 11?-Hydroxysteroid Dehydrogenase Type 1 Occupancy by Xanamem (Pubmed Central) - Feb 5, 2024
TAC, SUV40-60, and VT measures indicate Xanamem achieves high target occupancy levels with near saturation at 10?mg daily. These data support exploration of doses of?10?mg daily in future clinical studies.

||||||||||  Xanamem (UE2343) / Actinogen Medical
Phase classification:  XanaMIA: Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease (clinicaltrials.gov) -  Nov 22, 2023
P2, N=220, Not yet recruiting,  Sponsor: Actinogen Medical
These data support exploration of doses of?10?mg daily in future clinical studies. Phase classification: P2b --> P2

|||||||||| Xanamem (UE2343) / Actinogen Medical
Xanamem shows pro-cognitive activity with clinically meaningful effect sizes across 3 independent, placebo-controlled clinical trials (In-Person) - Jul 6, 2023 - Abstract #AAIC2023AAIC_3853;
Xanamem displays activity in multiple domains of cognition including attention, working memory, and executive function with clinically meaningful effects in normal subjects and in patients with p-Tau-elevated mild AD. These data suggest Xanamem may be both a pro-cognitive drug and disease-modifying agent and guide design of future trials.

|||||||||| Xanamem (UE2343) / Actinogen Medical
UTILITY OF PLASMA P-TAU181 AS A PREDICTOR OF PROGRESSION AND XANAMEM CLINICAL EFFECT IN MILD ALZHEIMER'S DISEASE: XANADU PHASE 2A BIOMARKER TRIAL (ONSITE - HALL C) - Dec 23, 2022 - Abstract #ADPD2023ADPD_288;
Treatment did not change plasma biomarker levels. Conclusions Selecting patients with mild AD by plasma p-tau181 to enrich for risk of disease progression can aid the demonstration of clinical benefit, as seen in this study of Xanamem treatment over 12 weeks.

||||||||||  Xanamem (UE2343) / Actinogen Medical
New P2 trial:  Xanamem (clinicaltrials.gov) -  Dec 20, 2022
P2, N=160, Recruiting,  Sponsor: Actinogen Medical

|||||||||| Xanamem (UE2343) / Actinogen Medical
XANAMIA PHASE 1B TRIAL WITH XANAMEM® ACHIEVES PRIMARY ENDPOINTS: RESULTS AND STRATEGIC UPDATE. () - Oct 5, 2022 - Abstract #CTAD2022CTAD_194;
While the cognition data were somewhat variable, the pattern of response was consistent with results from the prior randomized trial. These results strongly support continuation of the Xanamem Phase 2 trial program using a dose range ≤ 10 mg.

||||||||||  Xanamem (UE2343) / Actinogen Medical
Trial completion, Trial completion date:  XanaMIA-DR: A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers (clinicaltrials.gov) -  Apr 8, 2022
P1/2, N=107, Completed,  Sponsor: Actinogen Medical
These results strongly support continuation of the Xanamem Phase 2 trial program using a dose range ≤ 10 mg. Active, not recruiting --> Completed | Trial completion date: Jun 2022 --> Feb 2022

||||||||||  Xanamem (UE2343) / Actinogen Medical
Enrollment closed:  XanaMIA-DR: A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers (clinicaltrials.gov) -  Dec 7, 2021
P1/2, N=105, Active, not recruiting,  Sponsor: Actinogen Medical
Active, not recruiting --> Completed | Trial completion date: Jun 2022 --> Feb 2022 Recruiting --> Active, not recruiting

|||||||||| Xanamem (UE2343) / Actinogen Medical
Assessing 11β-HSD1 in vivo occupancy by Xanamem® using 11C-TARACT PET (Ballroom) - Aug 7, 2021 - Abstract #CTAD2021CTAD_26;
11C-TARACT PET studies provide a robust and non-invasive way to determine the degree of 11β-HSD1 occupancy by Xanamem®. The data enables more targeted future clinical trials where the dose of Xanamem® can be tailored to the desired level of enzyme occupancy.

||||||||||  Xanamem (UE2343) / Actinogen Medical
New P1/2 trial:  XanaMIA-DR: A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers (clinicaltrials.gov) -  Jul 30, 2021
P1/2, N=105, Recruiting,  Sponsor: Actinogen Medical

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[VIRTUAL] Actinogen Medical Limited () - Apr 3, 2021 - Abstract #BIO2021BIO_54;
There is a strong association between persistent stress and the production of excess cortisol that leads to detrimental changes in the brain, affecting memory, cognitive function and behaviour and neuropsychological symptoms. The Company plans to initiate Phase II studies of Xanamem in various disease areas in 2021, including MCI due to Alzheimer’s disease, and Fragile X syndrome.

||||||||||  Xanamem (UE2343) / Actinogen Medical
Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  XanaHES: Xanamem (clinicaltrials.gov) -  Aug 8, 2020
P1, N=42, Completed,  Sponsor: Actinogen Medical
The Company plans to initiate Phase II studies of Xanamem in various disease areas in 2021, including MCI due to Alzheimer’s disease, and Fragile X syndrome. Recruiting --> Completed | N=84 --> 42 | Trial completion date: May 2020 --> Jan 2020 | Trial primary completion date: May 2020 --> Dec 2019

|||||||||| Xanamem (UE2343) / Actinogen Medical
[VIRTUAL] Results and Drug Development Summary for Xanamem, a Potent Inhibitor of the 11-HSD1 Enzyme () - Aug 2, 2020 - Abstract #AAIC2020AAIC_3343;
Recruiting --> Completed | N=84 --> 42 | Trial completion date: May 2020 --> Jan 2020 | Trial primary completion date: May 2020 --> Dec 2019 Xanamem provides a mode of action wherein it inhibits cortisol production; the results achieved to date further endorses this scientifically robust target for both symptomatic treatment and disease course modification in AD and potentially non-AD dementias and other neurodegenerative disorders.

|||||||||| Xanamem (UE2343) / Actinogen Medical
[VIRTUAL] CHRONICALLY ELEVATED CORTISOL AND COGNITIVE IMPAIRMENT: THE THERAPEUTIC POTENTIAL OF XANAMEM™, A POTENT INHIBITOR OF THE 11Β-HSD1 ENZYME (Hall M) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_330;
Future Studies The results achieved indicate successful target engagement and target ocupancy of Xanamem™ and highlight the potential that future clinical studies may elicit clinically meaningful results in the target population. Conclusions Xanamem™ provides a mode of action wherein it inhibits cortisol production; the results achieved in XanaHES further endorse this scientifically robust target for both symptomatic treatment and disease course modification in AD and potentially non-AD dementias and other neurodegenerative disorders.

||||||||||  Xanamem (UE2343) / Actinogen Medical
Trial completion date, Trial primary completion date:  XanaHES: Xanamem™ in Healthy Elderly Subjects (clinicaltrials.gov) -  Jun 25, 2019
P1, N=84, Recruiting,  Sponsor: Actinogen Medical
Conclusions Xanamem™ provides a mode of action wherein it inhibits cortisol production; the results achieved in XanaHES further endorse this scientifically robust target for both symptomatic treatment and disease course modification in AD and potentially non-AD dementias and other neurodegenerative disorders. Trial completion date: Dec 2019 --> May 2020 | Trial primary completion date: Dec 2019 --> May 2020

||||||||||  Xanamem (UE2343) / Actinogen Medical
Trial completion, Trial completion date:  A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (clinicaltrials.gov) -  May 9, 2019
P2, N=186, Completed,  Sponsor: Actinogen Medical
Trial completion date: Dec 2019 --> May 2020 | Trial primary completion date: Dec 2019 --> May 2020 Active, not recruiting --> Completed | Trial completion date: Jul 2019 --> Mar 2019

||||||||||  Xanamem (UE2343) / Actinogen Medical
New P1 trial:  XanaHES: Xanamem™ in Healthy Elderly Subjects (clinicaltrials.gov) -  Feb 5, 2019
P1, N=84, Recruiting,  Sponsor: Actinogen Medical

||||||||||  Xanamem (UE2343) / Actinogen Medical
Enrollment closed, Trial completion date, Trial primary completion date:  A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (clinicaltrials.gov) -  Nov 1, 2018
P2, N=174, Active, not recruiting,  Sponsor: Actinogen Medical
Active, not recruiting --> Completed | Trial completion date: Jul 2019 --> Mar 2019 Recruiting --> Active, not recruiting | Trial completion date: Mar 2019 --> Jul 2019 | Trial primary completion date: Jan 2019 --> Apr 2019

||||||||||  Xanamem (UE2343) / Actinogen Medical
Enrollment open:  A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (clinicaltrials.gov) -  Mar 24, 2017
P2, N=174, Recruiting,  Sponsor: Actinogen Medical
Recruiting --> Active, not recruiting | Trial completion date: Mar 2019 --> Jul 2019 | Trial primary completion date: Jan 2019 --> Apr 2019 Not yet recruiting --> Recruiting

||||||||||  Xanamem (UE2343) / Actinogen Medical
Trial initiation date, Trial primary completion date:  A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (clinicaltrials.gov) -  Jan 4, 2017
P2, N=174, Not yet recruiting,  Sponsor: Actinogen Medical
Not yet recruiting --> Recruiting Initiation date: Jun 2016 --> Mar 2017 | Trial primary completion date: Jun 2018 --> Mar 2019

||||||||||  Xanamem (UE2343) / Actinogen Medical
New P2 trial:  A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (clinicaltrials.gov) -  Apr 6, 2016
P2, N=200, Not yet recruiting,  Sponsor: Actinogen Medical

||||||||||  Xanamem (UE2343) / Actinogen Medical
New P1 trial:  Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects (clinicaltrials.gov) -  Nov 30, 2015
P1, N=40, Completed,  Sponsor: Actinogen Medical

||||||||||  Xanamem (UE2343) / Actinogen Medical
Trial completion:  A Phase I Study of Oral UE2343 in Healthy Subjects (clinicaltrials.gov) -  Jul 15, 2013
P1, N=48, Completed,  Sponsor: University of Edinburgh
Initiation date: Jun 2016 --> Mar 2017 | Trial primary completion date: Jun 2018 --> Mar 2019 Recruiting --> Completed

||||||||||  Xanamem (UE2343) / Actinogen Medical
New P1 trial:  A Phase I Study of Oral UE2343 in Healthy Subjects (clinicaltrials.gov) -  Jan 16, 2013
P1, N=48, Completed,  Sponsor: University of Edinburgh



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