Core Viewpoint - Tiziana Life Sciences has initiated a Phase 2 clinical trial for intranasal foralumab, targeting early Alzheimer's disease, marking a significant step in exploring immunomodulatory therapies for neuroinflammation [1][3][7]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized and placebo-controlled, assessing the safety, tolerability, and potential efficacy of intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab [4]. - Primary endpoints of the trial include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers, with interim data expected in 2026 [4]. Group 2: Scientific Rationale - TSPO-PET imaging data indicates persistent microglial activation in Alzheimer's patients, even after treatment with anti-amyloid therapies, highlighting the need for therapies that address residual neuroinflammation [2]. - Intranasal foralumab is designed to modulate immune responses and reduce activated microglia, potentially slowing disease progression in early Alzheimer's disease [2][3]. Group 3: Company Insights - Gabriele Cerrone, Chairman & Founder, emphasized the importance of this trial in exploring a novel approach to Alzheimer's treatment, building on previous data showing foralumab's ability to reduce microglial activation in multiple sclerosis patients [3]. - Ivor Elrifi, CEO, expressed enthusiasm for the rapid progress from enrollment to first patient dosing, reflecting the urgent need for new treatment strategies beyond amyloid clearance [3]. Group 4: About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with previous studies showing positive outcomes in patients with non-active secondary progressive multiple sclerosis [5][6]. - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [6]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, aiming to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6][8].

First Patient Expected to be Dosed Next Week with Intranasal ForalumabPET Scan Shows Presence of Untreated Neuroinflammation in Alzheimer’s Patient on Leqembi® (Lecanemab) Anti-Amyloid Therapy BOSTON, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that enrolment ...

Prothena Corporation FY Conference Summary Company Overview - **Company**: Prothena Corporation (NasdaqGS:PRTA) - **Focus**: Expertise in protein dysregulation with a robust pipeline in neurodegenerative diseases, including Alzheimer's, Parkinson's, and ATTR cardiomyopathy [2][22] Key Programs and Developments - **Phase 3 Programs**: - **Prasunezumab**: Targeting early Parkinson's disease in collaboration with Roche, expected to initiate in Q4 2025 [2][22] - **Coramitug**: Targeting ATTR cardiomyopathy in collaboration with Novo, which has already initiated Phase 3 [2][22] - **Phase 2 Program**: - **PRX019**: Targeting tau in Alzheimer's disease, partnered with Bristol Myers Squibb [2][22] - **Phase 1 Program**: - **PRX012**: An undisclosed target for neurodegeneration, also partnered with Bristol [2][22] Financial Outlook - Prothena anticipates earning up to **$105 million** in clinical milestones in 2026 related to coramitug and PRX019 [2][22] Shareholder Actions - Recently approved a share repurchase program for 2026 to support distributable reserves [2][22] Pipeline Insights - **Alzheimer's Program**: The company is exploring partnerships to advance its amyloid beta program, emphasizing the importance of collaboration for cost efficiency and bandwidth [4][5] - **Transferrin Technology**: Prothena is developing PRX012, which incorporates transferrin technology to enhance blood-brain barrier penetration. Preclinical data is expected in 2026 [7][17][18] Clinical Data and Efficacy - **Amyloid Reduction**: Over **80%** of patients treated with the amyloid beta molecule are reported to be amyloid negative after 18 months [5][6] - **ARIA Rates**: Reported around **40%** for the amyloid beta treatment, with ongoing efforts to mitigate these effects [6][7] - **Coramitug Data**: Recent presentations showed a **50%** difference from placebo in NT-proBNP levels, supporting the move to Phase 3 [24][25] Collaborations and Partnerships - Prothena has established strong collaborations with Roche, Novo, and Bristol Myers Squibb, focusing on scientific dialogue and clinical decision-making [22][26] - The company is actively supporting partner programs as they transition into Phase 3 [26] Regulatory Considerations - The company is preparing for potential IND submissions, with ongoing discussions with the FDA regarding preclinical toxicology requirements [8][9] Market Position and Future Directions - Prothena is positioning itself to leverage its unique constructs in the competitive landscape of Alzheimer's treatments, particularly with its transferrin-based technology [17][40] - The company is closely monitoring developments in the field, including Eli Lilly's studies, to inform its strategic direction [5][40] Conclusion - Prothena Corporation is advancing multiple promising programs in neurodegenerative diseases, with a strong focus on collaboration and innovative technologies to enhance treatment efficacy and patient outcomes [2][22][40]

Eli Lilly and Company (India) on Tuesday said it has received approval from national drug regulator CDSCO for a drug to treat Alzheimer's disease. The company has received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for donanemab (350 mg/20 mL), administered every four weeks via intravenous infusion, for the treatment of Alzheimer's disease in adults with early symptomatic stages. This includes individuals with mild cognitive impairment and those in the mild dementia ...

Core Insights - Eli Lilly and Company is recognized as one of the best healthcare stocks to buy and hold for five years due to its strong market position and innovative product portfolio [2] Group 1: Company Overview - Eli Lilly is a global biopharmaceutical leader with a focus on diabetes, obesity, oncology, immunology, and neurology [2] - The company has a portfolio that includes blockbuster drugs such as Mounjaro and Zepbound for diabetes and obesity, and donanemab for Alzheimer's disease [2] Group 2: Expansion Plans - In September 2025, Eli Lilly announced plans for a $6.5 billion manufacturing facility in Houston, Texas, aimed at expanding production for small-molecule medicines, including orforglipron [3] - The new facility is expected to create several hundred jobs and will be operational within five years, reinforcing the company's commitment to next-generation obesity treatments [3] Group 3: International Growth - Eli Lilly is pursuing international growth with plans to launch orforglipron in India, pending regulatory approval, to capture demand for oral weight-loss drugs in emerging markets [4] - The company has streamlined its pipeline by halting the development of a muscle-preserving drug paired with Zepbound to focus on its most promising obesity assets [4] Group 4: Regulatory Approvals and Financial Performance - Eli Lilly strengthened its neurology portfolio as European regulators granted marketing authorization for donanemab, enhancing its position in Alzheimer's disease therapies [5] - The firm reported strong international growth for Mounjaro, although U.S. sales faced slight challenges due to isolated formulary issues, yet global demand for tirzepatide-based treatments remains robust [5]