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Web Release
04-08-2025
- Health
- Web Release
Lilly's Kisunla (donanemab-azbt) showed growing benefit over three years in early symptomatic Alzheimer's disease
Eli Lilly and Company (NYSE: LLY) announced results from the long-term extension (LTE) of the Phase 3 TRAILBLAZER-ALZ 2 study showing that participants treated with Kisunla (donanemab-azbt) demonstrated slowing of decline, a benefit that continued to grow over three years compared to an untreated external cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI). Participants in the study who started treatment later still saw benefit. However, earlier initiation of Kisunla in study participants significantly reduced the risk of progression to the next stage of the disease compared to those who received Kisunla treatment later. These data were shared as a late breaking 2025 Alzheimer's Association International Conference (AAIC) presentation in Toronto. 'The TRAILBLAZER-ALZ 2 long-term extension reaffirms that Kisunla delivered sustained clinical benefit that continued to increase over three years and a consistent safety profile,' said Mark Mintun, M.D., group vice president, Neuroscience Research & Development, Eli Lilly and Company. 'Participants continued to show meaningful outcomes, reinforcing the long-term value of early intervention.' The TRAILBLAZER-ALZ 2 LTE study was a Phase 3, double-blind extension of the original TRAILBLAZER-ALZ 2 trial, evaluating the efficacy and safety of Kisunla in individuals with early symptomatic Alzheimer's disease. Participants originally treated with Kisunla either continued treatment or were switched to placebo, while those initially on placebo began Kisunla in a blinded manner. An external comparator group from ADNI was used to assess outcomes against a matched, untreated population. Key preliminary results from the TRAILBLAZER-ALZ 2 LTE study include: Kisunla benefit continued to grow over three years for participants treated in the study compared to those in the matched ADNI group. Kisunla reduced cognitive decline by -0.6 at 18 months and then –1.2 at 36 months on the Clinical Dementia Rating Sum of Boxes (CDR-SB) in patients initially treated with Kisunla in the core study compared to the ADNI group. Earlier initiation of Kisunla reduced the risk of progression to the next stage of disease by 27% on the Clinical Dementia Rating-Global Score (CDR-G) compared to a delayed initiation Kisunla group. More than 75% of participants treated with Kisunla reached amyloid clearance within 76 weeks of starting treatment. After up to 2.5 years of observed data in participants who had completed treatment, amyloid plaque reaccumulation remained slow at a rate of approximately 2.4 CL/year, consistent with prior observations and modeling. No new safety signals were observed in the LTE over the three years, further reinforcing the established safety profile for Kisunla. Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/with hemosiderin deposition are side effects within the class of amyloid targeting therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the apolipoprotein E ?4 (ApoE4) gene may be at higher risk of developing Alzheimer's disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers. Kisunla can also cause certain types of allergic reactions, some of which may be serious and life-threatening, that typically occur during infusion or within 30 minutes post-infusion. Headache is another commonly reported side effect. See the Indication and Safety Summary with Warnings below for additional information. About TRAILBLAZER-ALZ 2 Long-Term Extension (LTE) Study Participants in the TRAILBLAZER-ALZ 2 (core) study who completed the 76-week placebo-controlled period were eligible to continue into the participant- and investigator-blinded LTE period, lasting an additional 78 weeks. The LTE study included multiple treatment arms: Participants (n=550) initially treated with Kisunla in the main study either continued treatment in the LTE or were switched to placebo after meeting pre-defined amyloid clearance thresholds. These participants were followed in the LTE period to assess long-term Kisunla safety and durability of treatment effects. Participants receiving placebo in the main study switched to Kisunla at the start of the LTE period in a blinded manner to evaluate delayed treatment outcomes. These delayed start participants (n= 657) received Kisunla with the same dosing, administration and stopping criteria as the TRAILBLAZER-ALZ 2 trial. In the study, if the amyloid plaque level was <11 Centiloids on a single positron emission tomography (PET) scan or 11 to <25 Centiloids on 2 consecutive PET scans, the patient was eligible to be switched to placebo. For reference, <24.1 Centiloids on an amyloid PET scan is consistent with a negative visual read. About TRAILBLAZER-ALZ 2 Study and the TRAILBLAZER-ALZ Program TRAILBLAZER?ALZ 2 (NCT04437511) is a multicenter, randomized, double-blind, placebo-controlled (PC) Phase 3 trial designed to assess the efficacy and safety of donanemab in participants with early symptomatic Alzheimer's disease. Lilly continues to study donanemab Kisunla in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is evaluating the safety and efficacy of donanemab in patients with preclinical Alzheimer's disease to determine if it reduces risk of progression to symptomatic Alzheimer's disease. TRAILBLAZER-ALZ 5 is a registration trial for early symptomatic Alzheimer's disease currently enrolling in China, Korea, Taiwan, and other geographies. The TRAILBLAZER-ALZ 6 study recently completed the 18-month final study endpoint. Data from the study showed that a modified titration dosing schedule reduced the risk of ARIA-E compared to the TRAILBLAZER-ALZ 2 dosing regimen. These findings supported the FDA approval of an update to the U.S. prescribing information for Kisunla. This data was also presented at AAIC. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a treatment for people with early symptomatic Alzheimer's disease, and regulatory approval and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References
Yahoo
30-07-2025
- Health
- Yahoo
Lilly's Kisunla (donanemab-azbt) showed growing benefit over three years in early symptomatic Alzheimer's disease
Findings from the TRAILBLAZER-ALZ 2 long-term extension study highlight Kisunla continued to demonstrate slowing of decline, with most participants having completed treatment Data underscores the value of early intervention and supports a limited duration dosing approach with sustained long-term benefits INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from the long-term extension (LTE) of the Phase 3 TRAILBLAZER-ALZ 2 study showing that participants treated with Kisunla (donanemab-azbt) demonstrated slowing of decline, a benefit that continued to grow over three years compared to an untreated external cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI).1 Participants in the study who started treatment later still saw benefit. However, earlier initiation of Kisunla in study participants significantly reduced the risk of progression to the next stage of the disease compared to those who received Kisunla treatment later.1 These data were shared as a late breaking 2025 Alzheimer's Association International Conference (AAIC) presentation in Toronto. "The TRAILBLAZER-ALZ 2 long-term extension reaffirms that Kisunla delivered sustained clinical benefit that continued to increase over three years and a consistent safety profile," said Mark Mintun, M.D., group vice president, Neuroscience Research & Development, Eli Lilly and Company. "Participants continued to show meaningful outcomes, reinforcing the long-term value of early intervention." The TRAILBLAZER-ALZ 2 LTE study was a Phase 3, double-blind extension of the original TRAILBLAZER-ALZ 2 trial, evaluating the efficacy and safety of Kisunla in individuals with early symptomatic Alzheimer's disease.1 Participants originally treated with Kisunla either continued treatment or were switched to placebo, while those initially on placebo began Kisunla in a blinded manner. An external comparator group from ADNI was used to assess outcomes against a matched, untreated population. Key preliminary results from the TRAILBLAZER-ALZ 2 LTE study include: Kisunla benefit continued to grow over three years for participants treated in the study compared to those in the matched ADNI group. Kisunla reduced cognitive decline by -0.6 at 18 months and then -1.2 at 36 months on the Clinical Dementia Rating Sum of Boxes (CDR-SB) in patients initially treated with Kisunla in the core study compared to the ADNI group. Earlier initiation of Kisunla reduced the risk of progression to the next stage of disease by 27% on the Clinical Dementia Rating-Global Score (CDR-G) compared to a delayed initiation Kisunla group. More than 75% of participants treated with Kisunla reached amyloid clearance within 76 weeks of starting treatment. After up to 2.5 years of observed data in participants who had completed treatment, amyloid plaque reaccumulation remained slow at a rate of approximately 2.4 CL/year, consistent with prior observations and modeling. No new safety signals were observed in the LTE over the three years, further reinforcing the established safety profile for Kisunla. Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/with hemosiderin deposition are side effects within the class of amyloid targeting therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the apolipoprotein E ε4 (ApoE4) gene may be at higher risk of developing Alzheimer's disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers. Kisunla can also cause certain types of allergic reactions, some of which may be serious and life-threatening, that typically occur during infusion or within 30 minutes post-infusion.2,3 Headache is another commonly reported side effect. See the Indication and Safety Summary with Warnings below for additional information. About TRAILBLAZER-ALZ 2 Long-Term Extension (LTE) StudyParticipants in the TRAILBLAZER-ALZ 2 (core) study who completed the 76-week placebo-controlled period were eligible to continue into the participant- and investigator-blinded LTE period, lasting an additional 78 weeks. The LTE study included multiple treatment arms: Participants (n=550) initially treated with Kisunla in the main study either continued treatment in the LTE or were switched to placebo after meeting pre-defined amyloid clearance thresholds. These participants were followed in the LTE period to assess long-term Kisunla safety and durability of treatment effects. Participants receiving placebo in the main study switched to Kisunla at the start of the LTE period in a blinded manner to evaluate delayed treatment outcomes. These delayed start participants (n= 657) received Kisunla with the same dosing, administration and stopping criteria as the TRAILBLAZER-ALZ 2 trial. In the study, if the amyloid plaque level was <11 Centiloids on a single positron emission tomography (PET) scan or 11 to <25 Centiloids on 2 consecutive PET scans, the patient was eligible to be switched to placebo. For reference, <24.1 Centiloids on an amyloid PET scan is consistent with a negative visual read. About TRAILBLAZER-ALZ 2 Study and the TRAILBLAZER-ALZ ProgramTRAILBLAZER‐ALZ 2 (NCT04437511) is a multicenter, randomized, double-blind, placebo-controlled (PC) Phase 3 trial designed to assess the efficacy and safety of donanemab in participants with early symptomatic Alzheimer's disease. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is evaluating the safety and efficacy of donanemab in patients with preclinical Alzheimer's disease to determine if it reduces risk of progression to symptomatic Alzheimer's disease. TRAILBLAZER-ALZ 5 is a registration trial for early symptomatic Alzheimer's disease currently enrolling in China, Korea, Taiwan, and other geographies. The TRAILBLAZER-ALZ 6 study recently completed the 18-month final study endpoint. Data from the study showed that a modified titration dosing schedule reduced the risk of ARIA-E compared to the TRAILBLAZER-ALZ 2 dosing regimen. These findings supported the FDA approval of an update to the U.S. prescribing information for Kisunla. This data was also presented at AAIC. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla (donanemab-azbt), pronounced kih-SUHN-lah, is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease. Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures. Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk. Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion. Other common side effects Headache Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or Before you receive Kisunla, tell your healthcare provider: About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby. How to receive KisunlaKisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes. Learn more For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you. Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a treatment for people with early symptomatic Alzheimer's disease, and regulatory approval and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References Eli Lilly. A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2). identifier: NCT04437511. Updated May 4, 2025. Accessed September 30, 2024. Kisunla (donanemab-azbt). Prescribing Information. Lilly USA, LLC. Kisunla (donanemab-azbt). Medication Guide. Lilly USA, LLC. Refer to: Tammy McGuire; tmcguire@ 317-614-5132 (Media)Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-03-2025
- Health
- Yahoo
Reducing Your 'Bioenergetic Age' May Ward Off Alzheimer's, Study Finds
Your risk of developing Alzheimer's disease depends largely on your genes and your age, but that doesn't mean it's out of your hands. As a new study suggests, you might have more influence on the matter than you think. The study's authors introduce another key indicator for Alzheimer's risk that may warrant more attention: your 'bioenergetic age', which isn't necessarily the same as your chronological age. Bioenergetics is a field of biochemistry focused on the transformation of energy in living things. Your bioenergetic age represents how efficiently (i.e., how youthfully) your cells generate energy. This metric may not only improve the accuracy of Alzheimer's risk assessments, the study finds, but could also help empower patients to mitigate their own risk. While bioenergetic age is dictated partly by genes and the passage of time, it's malleable in ways chronological age is not. Previous research suggests that some people can reduce their bioenergetic age with healthy habits like physical activity. A simulated clinical trial conducted as part of the recent study showed that improving bioenergetic age may even curb the progression of Alzheimer's as effectively as lecanemab, a drug for treating the disease. "That's quite big because it means some people can lower their risk without the uncertain side effects of current treatments," says senior author Jan Krumsiek, physiologist at Weill Cornell Medicine. It may also help explain why Alzheimer's can progress so differently in people with similar early signs of the disease, like cells that begin using and producing energy less efficiently. While many people with this warning sign soon develop Alzheimer's symptoms, others mysteriously remain symptom-free for years. A special 'bioenergetic capacity' seems to protect these patients, helping them maintain normal energy levels despite pathological anomalies in their energy pathways, the researchers write. "In these cases, people can be unusually healthy when we look at their cognition," Krumsiek says. "They make it to old age without the kind of declines that usually creep in." The next step was to find a test that can identify which patients already have this higher bioenergetic capacity, and a way to cultivate it in those where it's lower. The researchers focused on a class of fatty acid metabolites known as acylcarnitines found in the blood, which previous studies have established as markers of cognitive decline and energy metabolism. Using data from the Alzheimer's Disease Neuroimaging Initiative (ADNI), they investigated whether acylcarnitine levels in blood can clarify Alzheimer's risk. Higher acylcarnitine levels correlate with a higher bioenergetic age, which is associated with more severe Alzheimer's pathology and cognitive decline, the study found. The researchers used a common 11-question test to assess cognitive decline, finding patients with low acylcarnitine levels declined less quickly, losing about half a point less per year than patients with high acylcarnitine levels. That rate is comparable to that of patients taking lecanemab, they add, suggesting that having a lower bioenergetic age could be protective against Alzheimer's. "It was fascinating," Krumsiek says. "Dividing research participants into groups based on their specific acylcarnitine levels highlighted people with more severe Alzheimer's disease and others with fewer symptoms." This suggests acylcarnitines can help us read our bioenergetic clocks, revealing how old we seem based on our metabolism rather than the date of our birth. Luckily, a cheap test for acylcarnitine levels in blood already exists. "It's fortunate that these blood tests – originally developed to identify metabolic and mitochondrial disorders in newborns – can also help assess a person's bioenergetic age," Krumsiek says. "If we can repurpose this technology for older adults, that could provide a way to start personalized treatment earlier." That treatment could include behavioral shifts to boost exercise and nutrition, reducing patients' bioenergetic age and thus their Alzheimer's risk. Interventions like these might yield the most benefit for patients with a high bioenergetic age but also a favorable genetic profile, the researchers suggest, noting that about 30 percent of participants from the ADNI study fit that description. Future research should also explore which interventions are most effective in reducing a person's bioenergetic age, the researchers say. The study was published in Nature Communications. Exercise Boosts Brain Function Across All Ages, Massive Study Confirms Pouring Coffee Into Your Rectum Isn't Worth The Risk, Says Expert Oral Cancer Cases Are on The Rise, And Sugary Drinks Could Be to Blame
Globe and Mail
04-03-2025
- Business
- Globe and Mail
IGC Pharma Expands AI Platform With Advanced Diagnostic Model for Alzheimer's and Dementia Detection
POTOMAC, MD / ACCESS Newswire / March 4, 2025 / IGC Pharma, Inc. ("IGC" or the "Company") (NYSE American:IGC) today announced an advancement in its Artificial Intelligence ("AI") platform with the development of a new AI-driven model designed to improve the diagnosis of Alzheimer's disease (AD) and other causes of dementia. With Alzheimer's accounting for approximately 60-80% of all dementia cases, alongside other conditions such as vascular disease, Lewy body disease, and frontotemporal degeneration, accurate diagnosis is critical to ensuring the right treatment strategy. Dementia affects over 55 million people worldwide, causing progressive cognitive decline, memory loss, and behavioral changes. Despite its widespread impact, current diagnostic methods often rely on invasive procedures, expensive imaging, and subjective clinical assessments, leading to high rates of misdiagnosis and delayed treatment. IGC Pharma's cutting-edge AI model is designed to address these challenges by integrating vast clinical datasets and leveraging deep learning algorithms to distinguish between the different diseases that cause dementia. By reducing false negatives and misdiagnoses, the model has the potential to significantly improve early detection, ensuring patients receive the right treatment at the right time. The AI model is being trained on multi-modal clinical data from leading public research databases, including the National Alzheimer's Coordinating Center (NACC), the Alzheimer's Disease Neuroimaging Initiative (ADNI), and the Parkinson's Progression Markers Initiative (PPMI), among others. By analyzing neuroimaging biomarkers, cognitive assessments, genetic risk factors, medical history, neurological exams, and demographic information, IGC Pharma's AI-driven approach enables a more precise and scalable diagnostic framework. Using state-of-the-art transformer-based neural networks, the model's architecture is designed to process diverse patient data while compensating for missing information-delivering reliable, personalized insights across different patient populations. "The AI model is a potential game changer for our growth strategy. Our AI platform is a key driver of IGC Pharma's long-term growth strategy, reinforcing our commitment to precision medicine and targeted treatments for neurodegenerative diseases," said Ram Mukunda, CEO of IGC Pharma. "Misdiagnosis remains a significant challenge, often delaying treatment for patients who need it most. Our AI-driven model aims to close this gap, ultimately improving patient outcomes." This initiative is part of IGC Pharma's broader AI strategy, positioning the company at the forefront of innovation in Alzheimer's research. The development of an AI foundation model for Alzheimer's disease and dementia detection represents a transformative step forward, not only in advancing medical breakthroughs but also in enhancing the Company's long-term value and leadership in AI-driven healthcare solutions. About IGC Pharma (dba IGC): IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia ("CALMA") associated with Alzheimer's ( IGC Pharma Phase II). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 32 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions. The Company operates a wellness brand offering scientifically formulated products under the brand Holiby™ and as white-labeled formulations. Forward-Looking Statements This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Q filed with the SEC on August 7, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. SOURCE: IGC Pharma, Inc. View the original press release on ACCESS Newswire
