Hyalolex (IGC-AD1) / IGC Pharma - LARVOL DELTA

IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Miami Jewish Health (ACCESSWIRE) - "IGC Pharma, Inc...announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes."

Trial status • Alzheimer's Disease • Dementia

IGC Pharma Names IGC-AD1 Phase 2 Clinical Trial for Alzheimer's Agitation 'CALMA' and Expands Recruitment Strategy (ACCESSWIRE) - "IGC Pharma, Inc...announced today that its ongoing Phase 2 trial for agitation in Alzheimer's disease has been officially named CALMA (Calming Agitation in Alzheimer's)...IGC Pharma is expanding the campaign to the other trial locations, with the goal of completing enrollment and the CALMA trial in the second half of 2025."

Enrollment status • Trial completion • Alzheimer's Disease • Dementia

Developing Topics. (PubMed, Alzheimers Dement) - "Future imaging studies could explore the use of radioactive potassium tracers for diagnosis. The study provides insights into a) potassium as a potential blood-based diagnostic biomarker for AD and b) the potential of IGC-AD1 as a disease-modifying medication, given the preliminary data showing a reduction in serum potassium levels in AD subjects post-treatment."

Journal • Alzheimer's Disease • CNS Disorders

Developing Topics. (PubMed, Alzheimers Dement) - "IGC-AD1 demonstrated tolerability and potential efficacy in reducing Neuropsychiatric Symptoms in AD, with NM showing greater reductions after 1- and 2-mL administrations, though similar reductions were observed with 3 mL. Further investigation with a larger sample is continuing."

Journal • Alzheimer's Disease • CNS Disorders • Psychiatry • CYP2C9

Developing Topics. (PubMed, Alzheimers Dement) - P1 | "IGC-AD1 was safe and well-tolerated, without causing or worsening delusions/hallucinations as evaluated by the NPI. Contrary to other findings related to cannabis use, we observed clinical reduction approaching, in some cases, statistical significance. The signals warrant further analysis in a larger trial."

Journal • Alzheimer's Disease • CNS Disorders • Psychiatry

Developing Topics. (PubMed, Alzheimers Dement) - "Based on this safety trial, the findings suggest that the treatment with THC and melatonin does not exert adverse effects on liver function in patients with AD. Overall, the treatment demonstrated good tolerability, with no significant differences in hepatic biomarkers compared to placebo, supporting its potential safety in elderly patients with AD. Future research should continue to monitor these biomarkers in larger, more diverse populations to confirm these findings and assess long-term safety and efficacy."

Biomarker • Clinical • Journal • Alzheimer's Disease • CNS Disorders

Developing Topics. (PubMed, Alzheimers Dement) - P1 | "In this limited sample size and trial, there were no significant differences in AE frequencies between the two CYP2C9 phenotypes IM and NM, suggesting that IGC-AD1 has a safety profile that does not vary greatly, based on these two CYP2C9 polymorphisms. This analysis and initial results are important because the pharmacokinetics of THC are different for IM and NM. We continue to study these and other polymorphisms of CYP2C9 to understand their impact on AEs as it is crucial for personalized treatment strategies for the aged AD population."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Hypertension • CYP2C9

Developing Topics. (PubMed, Alzheimers Dement) - "Although exogenous melatonin is often associated with sedation, the study indicates that IGC-AD1, containing melatonin, did not lead to the anticipated increase in sleep duration. Further research is needed to understand the underlying mechanisms and optimize therapeutic interventions for sleep disturbances in AD patients."

Clinical • Journal • Alzheimer's Disease • Anesthesia • CNS Disorders • Pain • Sleep Disorder

Developing Topics. (PubMed, Alzheimers Dement) - "Melatonin when administered jointly with THC could play a significant role in THC absorption and PK. We hypothesize, pending more studies, that the higher reported dose-dependent absorption of THC may be related to the effect of melatonin on gastrointestinal transporters and efflux pumps."

Journal • Review • Alzheimer's Disease • CNS Disorders • Gastrointestinal Disorder • Hepatology • Insomnia • Liver Failure • Pain • Sleep Disorder

IGC Pharma Advances IGC-AD1 as a Potential Alzheimer's Therapy Addressing Cognitive Impairment and Underlying Disease Pathology (Yahoo Finance) - "IGC Pharma, Inc...announced today an expansion of its clinical research program for IGC-AD1, an investigational treatment for Alzheimer's disease. Building on Phase 2 interim results demonstrating reductions in agitation and cognitive improvement, the Company is initiating new trials to evaluate IGC-AD1's potential as a disease-modifying therapy...'We plan to initiate a new Phase 2 clinical trial for IGC-AD1 in 2025,'...The ongoing 146-patient Phase 2 trial continues to enroll participants across the USA and Canada. With over 1,000 doses administered and no serious adverse events reported, the trial is on track to deliver comprehensive safety and efficacy data in 2025."

New P2 trial • P2 data • Alzheimer's Disease • CNS Disorders

IGC Pharma Announces Additional Phase 2 Interim Results Highlighting Cognitive Benefits of IGC-AD1 for Alzheimer's Treatment (Businesswire) - P2 | N=164 | IGC-AD1-P2 (NCT05543681) | Sponsor: IGC Pharma LLC | "Interim results from the trial demonstrated that the active treatment group receiving IGC-AD1 twice daily for six weeks showed an average improvement of about 8% on the Mini-Mental State Examination ('MMSE'), a validated clinical tool for assessing cognitive function. By contrast, the placebo group showed no improvement over the same period...As previously disclosed, interim results showed that IGC-AD1 significantly reduced agitation compared to placebo, with improvements observed as early as two weeks. Unlike the existing therapy, which often takes about 6–10 weeks to show results and carries a black box warning, IGC-AD1 offers rapid symptom relief with a favorable safety profile, making it a highly differentiated potential medication for managing agitation in Alzheimer's."

P2 data • Alzheimer's Disease • CNS Disorders

IGC Pharma Announces Patient Enrollment at Toronto's Baycrest in Phase 2 Trial Investigating IGC-AD1 (ACCESSWIRE) - "IGC Pharma, Inc...today announced enrollment of patients at the Baycrest Academy for Research and Education in Toronto, Ontario, Canada, as part of the Company's ongoing Phase 2 trial investigating IGC-AD1 as a treatment for agitation in Alzheimer's dementia...IGC Pharma have 12 U.S. trial sites under contract and is on target to enroll additional sites in Canada to increase population diversity. The trial will enroll 164 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo."

Enrollment open • Alzheimer's Disease • CNS Disorders • Dementia

IGC Pharma Announces Additional Data Supporting IGC-AD1 as an Alzheimer's Treatment (Businesswire) - "IGC Pharma's findings from preclinical Alzheimer's cell line studies have revealed IGC-AD1's significant impact on tau pathology. The data shows that IGC-AD1 effectively reduced hyperphosphorylation of tau protein, a process strongly associated with the formation of neurofibrillary tangles ('NFT's), which are linked to cognitive decline...In addition, the combined APIs in IGC-AD1 reduced GSK3 enzyme expression by around 35%, an essential step in mitigating tangles. In addition, data also shows significant improvements in spatial memory from studies using an Alzheimer's mouse model."

Preclinical • Alzheimer's Disease • CNS Disorders

IGC Pharma Advances IGC-AD1 Toward Clinical Trials as a Potential anti-Amyloid Plaque Treatment for Alzheimer's Disease (Businesswire) - "IGC Pharma, Inc...announced today that the Company is advancing its proprietary formulation, IGC-AD1, toward clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer's disease....The initiation of disease-modifying investigational trials, expected in early 2025, will open a significant market opportunity for IGC Pharma."

New trial • Alzheimer's Disease • CNS Disorders

Effect of CYP2C9 Polymorphism on Neuropsychiatric Symptoms in Alzheimer’s Dementia (AAIC 2024) - "IGC-AD1 demonstrated tolerability and potential efficacy in reducing Neuropsychiatric Symptoms in AD, with NM showing greater reductions after 1- and 2-mL administrations, though similar reductions were observed with 3 mL. Further investigation with a larger sample is continuing."

Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry • CYP2C9

Exploring the Safety and Tolerability of IGC-AD1 in Alzheimer's Patients: Insights from CYP2C9 Polymorphism Assessment (AAIC 2024) - P1 | "In this limited sample size and trial, there were no significant differences in AE frequencies between the two CYP2C9 phenotypes IM and NM, suggesting that IGC-AD1 has a safety profile that does not vary greatly, based on these two CYP2C9 polymorphisms. This analysis and initial results are important because the pharmacokinetics of THC are different for IM and NM. We continue to study these and other polymorphisms of CYP2C9 to understand their impact on AEs as it is crucial for personalized treatment strategies for the aged AD population."

Clinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Hypertension • CYP2C9

Exploring the Impact of IGC-AD1 on Serum Potassium Levels in Alzheimer's Disease: Insights from a Phase I Trial (AAIC 2024) - "Future imaging studies could explore the use of radioactive potassium tracers for diagnosis. The study provides insights into a) potassium as a potential blood-based diagnostic biomarker for AD and b) the potential of IGC-AD1 as a disease-modifying medication, given the preliminary data showing a reduction in serum potassium levels in AD subjects post-treatment."

P1 data • Alzheimer's Disease • CNS Disorders

Effect of IGC-AD1 on Psychosis in Alzheimer's Disease: Results from a Phase 1 MAD Trial (AAIC 2024) - P1 | "IGC-AD1 was safe and well-tolerated, without causing or worsening delusions/hallucinations as evaluated by the NPI. Contrary t o other findings related to cannabis use, w e observed clinical reduction approaching, in some cases, statistical significance . The signals warrant further analysis in a larger trial."

P1 data • Alzheimer's Disease • CNS Disorders • Psychiatry

Assessing Sleep hours in Participants with Alzheimer’s Disease: Findings from a Phase I MAD Study of IGC-AD1 (AAIC 2024) - "Although exogenous melatonin is often associated with sedation, the study indicates that IGC-AD1, containing melatonin, did not lead to the anticipated increase in sleep duration. Further research is needed to understand the underlying mechanisms and optimize therapeutic interventions for sleep disturbances in AD patients."

P1 data • Alzheimer's Disease • Anesthesia • CNS Disorders • Pain • Sleep Disorder

Assessment of the Empact of IGC-AD1 on Hepatic Biomarkers in Alzheimer’s Disease: Insights from a Phase 1 Trial (AAIC 2024) - "Based on this safety trial, the findings suggest that the treatment with THC and melatonin does not exert adverse effects on liver function in patients with AD. Overall, the treatment demonstrated good tolerability, with no significant differences in hepatic biomarkers compared to placebo, supporting its potential safety in elderly patients with AD. Future research should continue to monitor these biomarkers in larger, more diverse populations to confirm these findings and assess long-term safety and efficacy."

Biomarker • P1 data • Alzheimer's Disease • CNS Disorders

Pharmacokinetic Effects of THC and Melatonin Co-administration in Elderly Population (AAIC 2024) - "IGC-AD1 comprises THC at a low concentration and melatonin... Melatonin when administered jointly with THC could play a significant role in THC absorption and PK. We hypothesize, pending more studies, that the higher reported dose-dependent absorption of THC may be related to the effect of melatonin on gastrointestinal transporters and efflux pumps."

Clinical • PK/PD data • Alzheimer's Disease • CNS Disorders • Gastrointestinal Disorder • Hepatology • Insomnia • Liver Failure • Pain • Sleep Disorder

Neurobiological Alterations in Agitation in Alzheimer's Disease and potential therapeutic intervention (AAIC 2024) - "The Phase-1 clinical study from IGC-AD1 indicates beneficial effects on agitative behavior in AD by reducing a clinically significant reduction in NPI Agitation and NPI-D scores ."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation

IGC Pharma Announces Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s Agitation (Businesswire) - P2 | N=164 | NCT05543681 | Sponsor: IGC Pharma LLC | "The interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo in patients with Alzheimer’s disease, indicating strong therapeutic potential for IGC-AD1....At the primary outcome, assessing the change in agitation as measured by the CMAI at week 6, the Cohen’s d effect size indicating the superiority of IGC-ADI over placebo was 0.66. The CMAI Least Square (“LS”) mean difference between active, and placebo was -10.45, with a p-value of 0.037 (for combined week two and week six results). In addition, at the pre-specified secondary endpoint, change at week two, the effect size was 0.79. The Cohen’s d is a standardized statistical effect size that describes the magnitude of the difference between two groups, taking into account the variability in outcomes."

P2 data • Alzheimer's Disease • CNS Disorders

IGC Pharma Announces TGR-63 Reduces Agitation in Alzheimer's Mouse Model (Businesswire) - "The Company is targeting a Phase 1 trial in 2024...IGC Pharma, Inc...announced additional positive results of preclinical studies investigating the Company's newly announced therapeutic candidate, TGR-63, a potential treatment for Alzheimer's disease. Previously disclosed results demonstrate that TGR-63 may successfully alleviate plaque burden in Alzheimer's cell lines and animal models...'We continue progressing IGC-AD1 and TGR-63 enthusiastically and anticipate clinical milestone updates throughout 2024 from our strengthened AD pipeline.'...The mice in the APP/PS1 group that received TGR-63 treatment showed significant improvements in their emotional well-being and anxiety levels compared to the group that didn't receive treatment. A series of tests were used to measure these improvements."

Clinical • New P1 trial • Preclinical • Alzheimer's Disease • CNS Disorders • Dementia

IGC Pharma Activates ClinCloud, One of 12 Sites in Ongoing Phase 2b Alzheimer’s Trial (Businesswire) - "IGC Pharma, Inc...announced that ClinCloud, a clinical research facility in Florida, has dosed its first patient as part of the Company’s ongoing Phase 2b trial. IGC Pharma is currently conducting a Phase 2b trial at twelve sites in the US and Canada with IGC-AD1, a combination medicine with a CB1 receptor partial agonist with anti-neuroinflammatory properties, and an inflammasome inhibitor to treat agitation in dementia from Alzheimer’s."

Trial status • Alzheimer's Disease • CNS Disorders • Dementia