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Rolling sBLA initiated to the U.S. FDA for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under Fast Track status
Prnewswire· 2025-09-03 03:01
Core Insights - BioArctic AB's partner Eisai has initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous autoinjector, following the FDA granting Fast Track Status [1][15] - Leqembi Iqlik, if approved, would be the first anti-amyloid treatment allowing at-home injection from the start, enhancing treatment accessibility for Alzheimer's disease patients [1][2] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, having developed Leqembi, the first drug proven to slow Alzheimer's disease progression [11] - The collaboration between BioArctic and Eisai dates back to 2005, with Eisai responsible for clinical development and commercialization, while BioArctic retains rights for commercialization in the Nordic region [4][10] Product Details - Leqembi is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, and is currently approved in 48 countries, with regulatory reviews ongoing in 10 countries [2][7] - The sBLA submission is based on Phase 3 clinical studies evaluating subcutaneous administration of lecanemab, which could offer a weekly starting dose as an alternative to bi-weekly intravenous dosing [2][3] Clinical Development - Eisai's ongoing Phase 3 clinical study (AHEAD 3-45) involves individuals with preclinical Alzheimer's disease and aims to assess the efficacy of lecanemab [9] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing, incorporating lecanemab as a key anti-amyloid therapy [9] Treatment Mechanism - Leqembi targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][14] - The subcutaneous formulation of Leqembi has the potential to reduce healthcare resource utilization associated with intravenous dosing, streamlining the treatment pathway for Alzheimer's disease [2]
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
Prnewswire· 2025-09-02 23:30
Core Insights - Eisai and Biogen announced the initiation of the rolling submission of the Supplemental Biologics License Application (sBLA) for LEQEMBI IQLIK, a subcutaneous autoinjector for Alzheimer's disease treatment, which would allow at-home administration [1][2][4] - LEQEMBI is currently approved in 48 countries and under regulatory review in 10 countries, indicating a strong global presence and ongoing expansion [3][32] Group 1: Product Development and Approval - The sBLA is based on evaluations from Phase 3 studies, showing the potential for a weekly dosing regimen of 500 mg via subcutaneous injection, which could provide an alternative to bi-weekly intravenous dosing [2][32] - The LEQEMBI IQLIK autoinjector is designed for ease of use, taking approximately 15 seconds for administration, which may enhance patient compliance and reduce healthcare resource utilization [2][3] Group 2: Mechanism of Action and Indications - LEQEMBI targets both amyloid plaques and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease, thus addressing the disease through multiple mechanisms [3][5][29] - The treatment is indicated for patients with Mild Cognitive Impairment (MCI) or mild dementia, representing an early intervention strategy in Alzheimer's disease [6][32] Group 3: Safety and Efficacy - The safety profile of LEQEMBI includes risks such as Amyloid-Related Imaging Abnormalities (ARIA), with symptomatic ARIA occurring in 3% of patients, and serious ARIA symptoms in 0.7% [10][11][25] - The incidence of intracerebral hemorrhage (ICH) was reported at 0.7% for LEQEMBI compared to 0.1% for placebo, highlighting the importance of monitoring during treatment [11][12] Group 4: Collaboration and Market Strategy - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product, indicating a strategic partnership aimed at maximizing market reach [4][34] - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development and commercialization of Alzheimer's treatments, which underscores the long-term commitment to addressing this disease [35][34]
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
GlobeNewswire News Room· 2025-09-02 23:30
Core Insights - Eisai Co., Ltd. and Biogen Inc. have initiated the rolling submission of a Supplemental Biologics License Application (sBLA) for lecanemab-irmb (LEQEMBI) subcutaneous autoinjector (SC-AI) to the U.S. FDA, following the grant of Fast Track Status [1][28] - The sBLA is based on Phase 3 clinical studies and aims to provide an alternative weekly dosing regimen for patients with early Alzheimer's disease (AD) [2][6] - LEQEMBI is currently approved in 48 countries and under regulatory review in 10 countries, indicating a strong global interest in the treatment [3][28] Company Overview - Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with co-commercialization efforts alongside Biogen [4][32] - The collaboration between Eisai and Biogen has been ongoing since 2014, focusing on the joint development and commercialization of Alzheimer's disease treatments [32] - Eisai's corporate concept emphasizes patient-centric approaches and aims to address high unmet medical needs, particularly in neurology [34] Product Details - LEQEMBI is indicated for the treatment of Alzheimer's disease, specifically for patients with Mild Cognitive Impairment (MCI) or mild dementia [6][27] - The new subcutaneous formulation is expected to streamline treatment pathways and reduce healthcare resource utilization compared to intravenous dosing [2][3] - The autoinjector allows for administration at home, enhancing patient convenience and adherence to treatment [2][28] Clinical Insights - LEQEMBI targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][5] - The treatment has shown a favorable safety profile, with specific monitoring guidelines for potential adverse effects such as Amyloid-Related Imaging Abnormalities (ARIA) [11][21] - Clinical trials have reported varying incidences of ARIA, with symptomatic ARIA occurring in 3% of patients treated with LEQEMBI [11][12] Market Potential - The approval of the subcutaneous formulation could position LEQEMBI as a leading treatment option for Alzheimer's disease, particularly in the U.S. market [1][28] - The ongoing Phase 3 clinical studies for preclinical Alzheimer's disease further highlight the potential for expanding the treatment's indications [29][30] - The collaboration with BioArctic has been instrumental in the development of lecanemab, showcasing the importance of strategic partnerships in advancing Alzheimer's therapies [27][33]
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status
Globenewswire· 2025-09-02 23:30
Core Insights - Eisai and Biogen announced the initiation of the rolling submission of the Supplemental Biologics License Application (sBLA) for LEQEMBI IQLIK, a subcutaneous autoinjector for lecanemab, which would be the first anti-amyloid treatment allowing at-home injection for Alzheimer's disease patients [1][2][28] - LEQEMBI is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, and the sBLA is based on Phase 3 clinical study data [2][6][28] - The FDA granted Fast Track Status to LEQEMBI IQLIK, which could provide patients with a weekly starting dose option, enhancing treatment accessibility and reducing healthcare resource utilization [1][2][3] Company Overview - Eisai serves as the lead for the global development and regulatory submissions of lecanemab, with co-commercialization responsibilities shared with Biogen [4][32] - Lecanemab has been approved in 48 countries and is under regulatory review in 10 additional countries, indicating a strong international presence [3][28] - The collaboration between Eisai and Biogen for Alzheimer's treatments has been ongoing since 2014, focusing on joint development and commercialization [32] Product Details - LEQEMBI targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][5] - The subcutaneous formulation of LEQEMBI is designed to streamline the treatment pathway for Alzheimer's patients, allowing for home administration and potentially reducing the need for intravenous (IV) dosing [2][3] - The current injection time for the LEQEMBI IQLIK autoinjector is approximately 15 seconds, making it a convenient option for patients [2] Clinical Data - The sBLA for LEQEMBI IQLIK is based on evaluations from the Phase 3 Clarity AD open-label extension study, which followed an 18-month core study [2] - The treatment is expected to provide a choice between IV and subcutaneous administration, enhancing patient and caregiver flexibility [2] - The safety profile of LEQEMBI IQLIK for maintenance treatment is reported to be similar to that of the intravenous formulation [26]
Biogen Secures FDA Nod for Subcutaneous Maintenance Dosing of Leqembi
ZACKS· 2025-09-01 15:36
Core Insights - Biogen has received FDA approval for a subcutaneous autoinjector version of Leqembi, named Leqembi Iqlik, which will serve as a weekly maintenance dosing option for early Alzheimer's disease treatment [1][9] - Patients can transition to Leqembi Iqlik after completing an 18-month course of biweekly infusions or choose a monthly intravenous dosing regimen that was previously approved [2] - The new subcutaneous version significantly reduces administration time from nearly one hour for IV infusions to about 15 seconds, allowing for at-home use [3][9] - Clinical studies support that the weekly maintenance dosing with Leqembi Iqlik maintains clinical and biomarker benefits similar to continued IV dosing, with a commercial launch planned for October 6, 2025 [4] - Leqembi was initially approved in 2023 for biweekly dosing in early Alzheimer's patients, with a similar approval in the European Union in April [5] Company Collaboration - Biogen developed Leqembi in collaboration with Eisai, which leads clinical development and regulatory submissions, while both companies co-commercialize the drug [6] Market Performance - Biogen's stock has underperformed compared to the industry year to date [7] - Leqembi sales showed significant growth, with Eisai reporting nearly $160 million in global revenues in Q2 2025, up from $96 million in the previous quarter, indicating strong market potential [10] Competitive Landscape - Currently, the FDA has approved two drugs for Alzheimer's disease: Leqembi and Kisunla, developed by Eli Lilly, both targeting early symptomatic Alzheimer's [11][12] - Kisunla has also seen rapid uptake, with sales increasing from $21.5 million to $48.6 million in the second quarter, reflecting a positive launch trajectory [13]
FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Globenewswire· 2025-08-29 21:00
Core Insights - LEQEMBI IQLIK is the first and only anti-amyloid treatment that allows for at-home injections, enabling patients and care partners to continue treatment after an initial 18-month intravenous therapy [1][2] - The U.S. FDA has approved the Biologics License Application for LEQEMBI IQLIK, which will be launched on October 6, 2025 [2][11] - The treatment is indicated for maintenance dosing in patients with mild cognitive impairment or mild dementia, following an initial 18-month intravenous treatment [2][16] Group 1: Treatment Mechanism and Efficacy - LEQEMBI targets both amyloid plaques and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [4][12] - Clinical trials indicate that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months maintains clinical and biomarker benefits comparable to continued intravenous dosing [5][40] - In the Clarity AD core study, treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [40] Group 2: Safety and Side Effects - The safety profile of LEQEMBI IQLIK is similar to that of intravenous treatment, with fewer systemic reactions reported [5][37] - Injection-related adverse events were less common with subcutaneous dosing, occurring in less than 1% of patients compared to approximately 26% with intravenous infusions [5][37] - The incidence of amyloid-related imaging abnormalities (ARIA) was similar between patients receiving the subcutaneous maintenance dose and those continuing with intravenous dosing [5][20] Group 3: Patient Support and Accessibility - Eisai offers various patient support programs in the U.S. to assist patients and care partners with treatment navigation and insurance coverage [9][10] - The Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost for eligible uninsured and underinsured patients [10] - The subcutaneous formulation is expected to reduce healthcare resource utilization associated with intravenous maintenance dosing, streamlining the overall Alzheimer's treatment pathway [8]
Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab)
Globenewswire· 2025-08-25 07:00
Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. have launched the anti-amyloid beta monoclonal antibody "LEQEMBI" in Austria and will launch it in Germany, marking the first launches in the EU after receiving European Commission approval in April 2025 for treating early Alzheimer's disease [1][2]. Company Overview - Eisai serves as the lead for the development and regulatory submissions of lecanemab globally, with both Eisai and Biogen co-commercializing and co-promoting the product [6][16]. - Biogen, founded in 1978, is a leading biotechnology company focused on innovative science to deliver new medicines and create value for shareholders [20]. Product Details - LEQEMBI targets both amyloid plaque and protofibrils, addressing a significant unmet need for new treatment options that slow the progression of Alzheimer's disease [3][9]. - The Clarity AD clinical trial demonstrated that treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating – Sum of Boxes (CDR-SB) by 31% at 18 months compared to placebo [4][12]. Clinical Trial Insights - The Clarity AD trial involved 1,795 patients with early Alzheimer's disease, with 1,521 in the EU indicated population (ApoE ε4 non-carriers or heterozygotes) [12]. - The most common adverse reactions in the EU indicated population included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%) [5][12]. Regulatory and Market Context - LEQEMBI has been approved in 48 countries and is under regulatory review in 10 countries, with a supplemental Biologics License Application for intravenous maintenance dosing approved in the U.S. [13][12]. - The controlled access program is in place in Austria and Germany to ensure patient safety and appropriate use of the medicine [2][8].
Silo Pharma’s Alzheimer’s Candidate SPC-14 Featured in Leading Scientific Peer-reviewed Journal
Globenewswire· 2025-08-21 18:00
Company Overview - Silo Pharma, Inc. is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system diseases [6] - The company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [6] Alzheimer's Disease Therapeutic Development - Silo Pharma announced the publication of preclinical research for its Alzheimer's disease therapeutic, SPC-14, in the journal Alzheimer's Research & Therapy [1] - The study titled "Combinatorial targeting of NMDARs and 5-HT4Rs exerts beneficial effects in a mouse model of Alzheimer's disease" indicates that the combined administration of (R,S)-ketamine with prucalopride is a novel multi-modal therapeutic strategy to treat cognitive decline in Alzheimer's disease [2] - The results showed that the SPC-14 formulation improved cognitive decline by increasing memory retrieval in a fear conditioning model in mice, identifying SPC-14 as a promising drug combination for therapeutic use in Alzheimer's disease [3] Market Potential - The Alzheimer's disease treatment market is projected to grow to $30.8 billion by 2033, with a compound annual growth rate (CAGR) of 18.8% [4] - SPC-14 was developed under a sponsored research agreement with Columbia University, and Silo Pharma entered into an exclusive global license agreement with the university to further develop, manufacture, and commercialize SPC-14 [4] Therapeutic Mechanism - SPC-14 is a novel intranasal therapeutic that targets glutamate receptor NMDAR and serotonin type 4 receptor 5HT4 to treat cognitive and neuropsychiatric symptoms in Alzheimer's disease [5] - In preclinical studies, SPC-14 was effective against luteinizing hormone stress, attenuating learned helplessness, perseverative behavior, and hyponeophagia, which is a measure of anxiety [5]
Silo Pharma's Alzheimer's Candidate SPC-14 Featured in Leading Scientific Peer-reviewed Journal
GlobeNewswire News Room· 2025-08-21 18:00
Core Insights - Silo Pharma, Inc. announced the publication of preclinical research for its Alzheimer's disease therapeutic, SPC-14, in a leading scientific journal, Alzheimer's Research & Therapy [1][2] - The study indicates that the combination of (R,S)-ketamine and prucalopride is a novel therapeutic strategy for treating cognitive decline in Alzheimer's disease [2] - SPC-14 has shown promising results in improving cognitive decline in preclinical models, suggesting its potential as a therapeutic option for Alzheimer's disease [3] Company Overview - Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company focused on addressing underserved conditions, including Alzheimer's disease [5] - The company has developed SPC-14 under a sponsored research agreement with Columbia University and has an exclusive global license to further develop and commercialize the product [4] - Silo's portfolio includes other innovative programs targeting conditions such as PTSD and chronic pain, indicating a broad therapeutic focus [5] Market Potential - The Alzheimer's disease treatment market is projected to grow to $30.8 billion by 2033, with a compound annual growth rate (CAGR) of 18.8% [4][7] - SPC-14 targets glutamate receptor NMDAR and serotonin type 4 receptor 5HT4, addressing cognitive and neuropsychiatric symptoms associated with Alzheimer's disease [4]
Alpha Cognition Inc(ACOG) - 2025 Q2 - Earnings Call Transcript
2025-08-14 21:30
Financial Data and Key Metrics Changes - For Q2 2025, the company generated total revenue of $1.7 million, consisting of $1.6 million in net product sales from Zunveil and $81,000 in licensing revenue from CMS [13] - Total costs and expenses for the quarter were $7.4 million, leading to an operating loss of $5.7 million compared to a loss of $2.4 million in Q2 2024 [14] - The net loss for Q2 2025 was $10.5 million or $0.65 per share, compared to a net loss of $2.1 million or $0.35 per share in the same quarter last year [15] Business Line Data and Key Metrics Changes - The commercial launch of Zunveil has seen prescriptions written in over 300 nursing homes, with 65% of these facilities placing repeat orders, indicating strong product trial [6][18] - The company reported approximately $2 million in net product revenues for Zunveil since its launch [13] Market Data and Key Metrics Changes - The company engaged with over 3,700 healthcare providers (HCPs) in the long-term care market during the quarter [6] - By the end of Q2, Zunveil had been ordered in over 300 long-term care homes, with 90% of orders filled despite increased prior authorization hurdles [20] Company Strategy and Development Direction - The company is focused on expanding Zunveil's presence in the long-term care market and optimizing its commercial strategy to enhance engagement with prescribers [27] - The company plans to advance its sublingual formulation and conduct a comparative pharmacokinetic study, with an IND submission anticipated in 2026 [7][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the initial traction of Zunveil and the potential for scalable growth in the coming quarters [13][17] - The company remains committed to disciplined expense management and anticipates full-year operating expenses in the range of $34 million to $38 million [16] Other Important Information - The company has made significant progress with its first ex-US partner, CMS Pharmaceuticals, which is on track to file in four additional countries by 2025 [11] - The company is well-capitalized with approximately $39.4 million in unrestricted cash as of June 30, 2025 [15] Q&A Session Summary Question: Can you characterize the typical profile of a repeat prescriber of Zunveil? - The company has identified high-volume nursing home facilities with a significant number of Alzheimer's patients as key targets for repeat prescriptions [31] Question: What is the expected state of contracting by the end of the year? - The company expects to have at least one more large national plan contracted by the end of the year, in addition to the existing contract [33] Question: Can you provide insights on prior authorization challenges? - The company has seen an increase in prior authorizations but reports that 90% of orders are being filled, albeit with some delays [39] Question: What is the anticipated monthly net revenue run rate for Q3? - The company anticipates a range of $5.75 to $6.25 million for the monthly net revenue run rate [41] Question: When should the second $3 million tranche from CMS be expected? - The company expects to receive the tranche in the last quarter of this year based on current progress [52] Question: Do you see any changes to the expected hockey stick-shaped revenue curve? - The company maintains its expectations for a hockey stick-shaped revenue curve, with significant growth anticipated in late 2026 and early 2027 [56]