A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin in Subjects with Mild to Moderately Severe Probable Alzheimer Disease

The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, activities of daily living, resource utilisation, safety and tolerability, in subjects with mild to moderately severe probable AD.
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.

Start Date01 Oct 2025

Sponsor / Collaborator

Cerecin, Inc.

NCT05628636 / CompletedPhase 1

A Phase 1, Open-label Study to Evaluate the Tolerability of 21 Days of Treatment With the AC-OLE-01-VA Formulation of Tricaprilin Under Different Dosing Conditions in Healthy Participants

This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin.
Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.

Start Date14 Nov 2022

Sponsor / Collaborator

Cerecin, Inc.

NCT05408780 / CompletedPhase 1

A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects

The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.

Start Date14 Jul 2022

Sponsor / Collaborator

Cerecin, Inc.

100 Clinical Results associated with Cerecin, Inc.

0 Patents (Medical) associated with Cerecin, Inc.

Literatures (Medical) associated with Cerecin, Inc.

01 Jan 2023·European Journal of Pharmaceutics and Biopharmaceutics

Modeling digestion, absorption, and ketogenesis after administration of tricaprilin formulations to humans

Article

Author: Henderson, Samuel ; Ramirez, Gisela ; Nair, Murali ; Morimoto, Bruce ; Tang, Rushi ; Wacker, Matthias G ; Liu, Julie ; Paul, Cheong Kin Xian ; Boyd, Ben J ; Li, Zhuoxuan ; Kaasgaard, Thomas

At present, tricaprilin is used as a ketogenic source for the management of mild to moderate Alzheimer's disease. After administration of the medium-chain triglyceride, tricaprilin is hydrolyzed to octanoic acid and further metabolized to ketones, acting as an alternative energy substrate for the brain. In this investigation, we developed a physiologically-based biopharmaceutics model simulating in vivo processes following the peroral administration of tricaprilin. The model includes multiple data sources to establish a partially verified framework for the simulation of plasma profiles. The input parameters were identified based on existing literature data and in vitro digestion studies. Model validation was conducted using the data from a phase I clinical trial. A partial parameter sensitivity analysis elucidated various influences on the plasma ketone levels that are mainly responsible for the therapeutic effects of tricaprilin. Based on our findings, we concluded that dispersibility and lipolysis of tricaprilin together with the gastric emptying patterns are limiting ketogenesis, while other steps such as the conversion of octanoic acid to ketone bodies play a minor role only.

19 May 2020·Journal of Alzheimer's DiseaseQ3 · MEDICINE

A Placebo-Controlled, Parallel-Group, Randomized Clinical Trial of AC-1204 in Mild-to-Moderate Alzheimer’s Disease

Q3 · MEDICINE

Article

Author: Cummings, Jeffrey L. ; Morimoto, Bruce H. ; Walker, Judith ; Farlow, Martin R. ; Henderson, Samuel T.

BACKGROUNDAlzheimer's disease (AD) is characterized by amyloid-β plaques, neurofibrillary tangles, and regional cerebral glucose hypometabolism. Providing an alternative metabolic substrate, such as ketone bodies, may be a viable therapeutic option.OBJECTIVEThe objective was to determine the efficacy and safety of the AC-1204 formulation of caprylic triglyceride administered daily for 26 weeks in APOE4 non-carrier participants with mild-to-moderate AD.METHODSIn a double-blind, placebo-controlled, randomized study (AC-12-010, NOURISH AD, NCT01741194), 413 patients with mild-to-moderate probable AD were stratified by APOE genotype and randomized (1 : 1) to receive either placebo or AC-1204 for 26 weeks. The primary outcome was the change from baseline to week 26 on the 11-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11) among APOE4 non-carriers. The key secondary outcome was the change from baseline to week 26 in the Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change scale.RESULTSAdministration of AC-1204 was safe and well-tolerated. Mean changes from baseline in the primary outcome at 26 weeks in ADAS-Cog11 for placebo (n = 138) was 0.0 and for AC-1204 (n = 137) was 0.6 (LS differences of mean - 0.761, p = 0.2458) and secondary outcome measures failed to detect any drug effects.CONCLUSIONThe AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD. The lack of efficacy observed in this study may have several contributing factors including a lower ketone body formation from AC-1204 than expected and a lack of decline in the patients receiving placebo.

Chimica Oggi

Peptide manufacturing scale-up: an emerging biotech prospective

Author: Stewart, Alistair J. ; Morimoto, Bruce H.

Peptides are often potent and highly selective for their targets, thereby attractive therapeutic modalities for the emerging biotech company to rapidly enter clin. development.Davunetide is a neuroprotective peptide previously in development for the treatment of Progressive Supranuclear Palsy (PSP), an orphan movement disorder.The accelerated development timeline required backend loading of many manufacturing activities including considerations for large scale peptide synthesis.Davunetide will be used as a case study for the transition from solid-phase to liquid-phase peptide synthesis.

News (Medical) associated with Cerecin, Inc.

28 Oct 2024

·www.prnewswire.com

Treg Cell-based Therapies Clinical Trial Pipeline Appears Robust With 51+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Treg Cell-based Therapies refer to therapeutic approaches that utilize regulatory T cells (Tregs) to modulate the immune system. Innovations in cell expansion and engineering techniques have greatly enhanced the ability to isolate, expand, and deliver functional Tregs. Ex vivo expansion technologies and genetic engineering (such as CAR-Tregs) have opened up new possibilities for enhancing the stability, specificity, and effectiveness of Treg therapies. LAS VEGAS, Oct. 28, 2024 /PRNewswire/ -- DelveInsight's ' Treg Cell-based Therapies Pipeline Insight 2024 ' report provides comprehensive global coverage of available, marketed, and pipeline Treg cell-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Treg cell-based therapies pipeline domain. Key Takeaways from the Treg Cell-based Therapies Pipeline Report DelveInsight's Treg cell-based therapies pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for various indications. Key Treg cell-based therapies companies such as Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others are evaluating new Treg cell-based therapies to improve the treatment landscape. Promising Treg cell-based therapies in the pipeline in various stages of development include Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. In October 2024, Quell Therapeutics hired eXmoor Pharma to make supplies of its pipeline of novel immunosuppressive cell therapies—called CAR-Tregs—at its new cell and gene therapy facility. Quell recently teamed with fellow U.K.-based eXmoor in a strategic partnership that will see the contractor make its candidate autoimmune disease cell therapies for early-phase clinical studies. In September 2024, Abata Therapeutics announced that ABA-101, an autologous regulatory T-cell (Treg) therapy for the treatment of patients with progressive multiple sclerosis (MS), has received fast-track designation from the US FDA. In September 2024, PolTREG S.A. announced that China's National Intellectual Property Administration, PRC (CNIPA) had issued a notification to grant a patent for the intrathecal administration of the company's cellular therapies in patients with multiple sclerosis (MS). The intrathecal administration is an established method used to deliver therapy across the blood-brain barrier via injection into the subarachnoid space. In June 2024, Orca Bio announced that it had completed enrollment in the pivotal Precision-T Phase III clinical study. The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). In March 2024, PolTREG announced that the company is planning to launch Phase II trials testing its Tregs therapy — the T-cell-based treatment PTG-007 in people with multiple sclerosis (MS). In February 2024, Cellenkos announced encouraging safety data from its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, being developed to help treat individuals with Amyotrophic Lateral Sclerosis (ALS). The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). In August 2023, BlueRock Therapeutics LP, a wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics. Request a sample and discover the recent advances in Treg cell-based therapies @ Treg Cell-based Therapies Pipeline Outlook The Treg cell-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Treg cell-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Treg cell-based therapies pipeline landscape. Treg Cell-based Therapies Overview Treg cell-based therapies represent a promising frontier in immunotherapy, focusing on harnessing regulatory T cells (Tregs) to modulate the immune response in various clinical settings. Tregs play a crucial role in maintaining immune homeostasis and preventing autoimmune reactions by suppressing excessive immune responses. In the context of autoimmune diseases, these therapies aim to restore balance by expanding or enhancing Tregs to dampen inappropriate immune activity. For instance, in diseases like type 1 diabetes or multiple sclerosis, Treg cell-based treatments seek to prevent or slow disease progression by reestablishing immune tolerance. Beyond autoimmune disorders, Treg cell-based therapies are also being explored in cancer treatment. Tumors often exploit Tregs to evade immune detection, and by manipulating these cells, it's possible to enhance the anti-tumor immune response. Strategies include expanding Tregs ex vivo and reinfusing them to boost their numbers or modifying them to more effectively target tumor-associated antigens. These approaches hold the potential to improve the efficacy of existing immunotherapies and offer new avenues for treating cancers that are currently resistant to conventional treatments. Find out more about Treg cell-based therapies @ Treg Cell-based Therapies in Development A snapshot of the Treg Cell-based Therapies Pipeline Drugs mentioned in the report: Learn more about the emerging Treg cell-based therapies @ Treg Cell-based Therapies Clinical Trials Treg Cell-based Therapies Therapeutics Assessment The Treg cell-based therapies pipeline report proffers an integral view of the emerging Treg cell-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Treg Cell-based Therapies Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Subcutaneous, Oral, Intramuscular Therapeutics Assessment By Molecule Type: Monoclonal antibody, Small molecule, Peptide Therapeutics Assessment By Mechanism of Action: Immunologic cytotoxicity, T lymphocyte replacements, Interleukin 2 replacements, Cell replacements Key Treg Cell-based Therapies Companies: Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others. Key Treg Cell-based Therapies in Pipeline: Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. Dive deep into rich insights for Treg cell-based therapies assessment, visit @ Treg Cell-based Therapies Therapeutics Assessment Table of Contents For further information on the Treg cell-based therapies pipeline therapeutics, reach out @ Treg Cell-based Therapies Pipeline Landscape Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. 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LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyCell TherapyFast TrackPhase 3

26 Aug 2024

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Global Wireless Brain Sensors Market to Accelerate Substantially at a CAGR of ~9% by 2030 | DelveInsight

The rising demand for wireless brain sensors is largely driven by the growing occurrence of neurological disorders, including dementia and epilepsy. Furthermore, the increasing cases of traumatic brain injuries worldwide and the expanding elderly population are significant factors contributing to the wireless brain sensors market's growth from 2024 to 2030. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- DelveInsight's Wireless Brain Sensors Market Insights report provides the current and forecast market analysis, individual leading wireless brain sensors companies' market shares, challenges, wireless brain sensors market drivers, barriers, trends, and key market wireless brain sensors companies in the market. Key Takeaways from the Wireless Brain Sensors Market Report As per DelveInsight estimates, North America is anticipated to dominate the global wireless brain sensors market during the forecast period. In the product type segment of the wireless brain sensors market, the devices category had a significant revenue share in the wireless brain sensors market in 2023. Notable wireless brain sensors companies such as NeuroSky, Advanced Brain Monitoring Inc., Koninklijke Philips N.V., Natus Medical Incorporated, NeuroWave Systems Inc., EMOTIV, BrainScope, InteraXon Inc., Cadwell Industries Inc., Neuroelectrics, Neuronetrix Solutions, LLC, Muse, and several others, are currently operating in the wireless brain sensors market. In May 2021, Neuroelectrics, a leader in brain stimulation technology development, raised USD 17.5 million in a Series A round led by Morningside Ventures. To read more about the latest highlights related to the wireless brain sensors market, get a snapshot of the key highlights entailed in the Global Wireless Brain Sensors Market Report Wireless Brain Sensors Overview Wireless brain sensors are a cutting-edge technology in the field of neuroengineering, designed to monitor brain activity without the need for cumbersome wires. These sensors can transmit data in real-time to external devices, enabling continuous monitoring of neural activity in a less invasive manner than traditional wired systems. They are often used in research to study brain functions, diagnose neurological disorders, and monitor patients with conditions such as epilepsy or Parkinson's disease. The wireless nature of these sensors allows for greater freedom of movement for patients, making long-term monitoring more feasible and less intrusive. The development of wireless brain sensors also opens new possibilities in brain-computer interface (BCI) technology. BCIs allow direct communication between the brain and external devices, which can be revolutionary for individuals with severe motor impairments. By using wireless brain sensors, these interfaces can become more practical and comfortable, paving the way for advancements in assistive technologies, such as controlling prosthetic limbs or computers through thought alone. Moreover, the miniaturization and increased sophistication of these sensors continue to improve their accuracy and reliability, making them a promising tool for both clinical applications and scientific research. Wireless Brain Sensors Market Insights North America dominated the wireless brain sensors market in 2023 among all regions, primarily due to the high incidence of neurological disorders. Contributing factors include favorable reimbursement policies, extensive research and development efforts, and a highly viable market for product development and launches. According to the Centers for Disease Control and Prevention (CDC) in 2023, 6.7 million Americans are living with Alzheimer's disease, a number expected to nearly triple to 14 million by 2060. Additionally, a May 2023 report by the United States Census Bureau indicated that the U.S. population aged 65 and over grew nearly five times faster than the total population from 1920 to 2020, reaching 55.8 million or 16.8% of the U.S. population in 2020. Aging naturally leads to changes in the brain, such as cell shrinkage and reduced blood flow, which can impair cognitive function and increase the risk of dementia. This underscores the significant need for the detection and diagnosis of such conditions, thereby boosting the demand for wireless brain sensors in the United States and, consequently, in North America. Moreover, key product launches and approvals in the region are further driving market growth. For instance, in February 2022, Masimo received FDA approval for the SedLine Pediatric EEG Sensor, extending its benefits to all patients aged one year and older in the United States. In summary, the combination of these factors and the ongoing introduction of new products and approvals are pivotal in driving North America's wireless brain sensors market during the forecast period. To know more about why North America is leading the market growth in the wireless brain sensors market, get a snapshot of the Wireless Brain Sensors Market Outlook Wireless Brain Sensors Market Dynamics The wireless brain sensors market is witnessing significant growth, driven by advancements in neurotechnology and a rising prevalence of neurological disorders. These sensors are pivotal in monitoring brain activity in a non-invasive manner, providing critical data for diagnosing and managing conditions like epilepsy, Parkinson's disease, and brain injuries. The increasing geriatric population, which is more susceptible to neurological ailments, further fuels the demand for innovative diagnostic and therapeutic solutions, propelling the expansion of this market. One of the primary market dynamics is technological innovation. The integration of wireless technology with brain sensors has revolutionized patient care by enabling continuous, real-time monitoring without the need for cumbersome wires. This enhances patient comfort and compliance, particularly in long-term monitoring scenarios. Moreover, advancements in miniaturization and biocompatibility of sensors have improved their safety and efficacy, broadening their application range from clinical settings to home healthcare environments. Companies are investing heavily in research and development to introduce more sophisticated, accurate, and user-friendly devices, which in turn accelerates market growth. Regulatory support and funding also play a crucial role in shaping the wireless brain sensors market. Governments and healthcare organizations worldwide are recognizing the potential of these sensors in improving patient outcomes and reducing healthcare costs. Consequently, there is an i ncrease in funding for research initiatives and favorable regulatory frameworks that streamline the approval process for new devices. This supportive environment encourages more companies to enter the market and innovate, fostering competitive dynamics and pushing the boundaries of what is technologically possible. However, challenges such as high costs and concerns regarding data privacy and security can impact wireless brain sensors market dynamics. The development and production of advanced wireless brain sensors involve significant investment, making them expensive and potentially limiting their accessibility. Additionally, as these devices generate and transmit sensitive neurological data, ensuring robust cybersecurity measures is paramount to protect patient information from breaches and misuse. Addressing these issues is critical for maintaining market momentum and gaining widespread acceptance among both healthcare providers and patients. In conclusion, the wireless brain sensors market is poised for robust growth, driven by technological advancements, an aging population, and supportive regulatory frameworks. While challenges such as high costs and data security need to be managed, the overall outlook remains positive. Continuous innovation and strategic collaborations among industry players are expected to further enhance the capabilities and accessibility of wireless brain sensors, ultimately transforming the landscape of neurological care and improving patient outcomes. Get a sneak peek at the wireless brain sensors market dynamics @ Wireless Brain Sensors Market Dynamics Analysis Wireless Brain Sensors Market Assessment Wireless Brain Sensors Market Segmentation Wireless Brain Sensors Market Segmentation By Product Type: Devices and Accessories Wireless Brain Sensors Market Segmentation By Application: Traumatic Brain Injury (TBI), Dementia, Epilepsy, and Others Wireless Brain Sensors Market Segmentation By End Users: Hospitals, Clinics, and Others Wireless Brain Sensors Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the wireless brain sensors market are set to emerge as the trendsetter explore @ Wireless Brain Sensors Companies Table of Contents Interested in knowing the wireless brain sensors market by 2030? 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About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Drug Approval

08 Jul 2024

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Eli Lilly's Donanemab Approval Heats Up Alzheimer's Disease Treatment Market | DelveInsight

In a much-anticipated decision, the FDA approved Eli Lilly's donanemab. This anti-amyloid antibody is the third drug intended to alter the progression of Alzheimer's disease treatment. This approval will intensify the competition between Eli Lilly's Donanemab and Biogen and Eisai's ADUHELM (aducanumab), and LEQEMBI (lecanemab). LAS VEGAS , July 8, 2024 /PRNewswire/ -- Alzheimer's disease, the most common type of dementia, is a progressive neurodegenerative disorder with a multifactorial pathogenesis. It is characterized by a gradual decline in cognitive and functional abilities, with individuals eventually losing the ability to undertake everyday tasks and function independently. As per DelveInsight analysis, in 2023, the total diagnosed prevalent cases of Alzheimer's disease in the 7MM were 15.4 million. These cases are projected to increase further during the forecast period (2024–2034). In 2023, the United States had the highest proportion of diagnosed prevalent cases of Alzheimer's disease among the 7MM, comprising approximately 41% of the total cases. Conversely, the United Kingdom had the lowest share, representing nearly 4% of the total diagnosed prevalent cases of Alzheimer's in 2023. As the size and proportion of the US population aged 65 and older continue to increase, the number of Americans with Alzheimer's or other dementias will grow. While there is no cure for Alzheimer's disease at present, starting treatment early and maintaining it consistently is crucial for alleviating clinical symptoms. Early diagnosis is vital for applying symptomatic therapies, addressing behavioral issues, and implementing lifestyle changes that can reduce the risk of dementia and potentially slow disease progression. Most current dementia treatments focus on increasing the levels of specific brain neurotransmitters like acetylcholine, serotonin, and noradrenaline, or decreasing the activity of others, such as glutamate and dopamine. Because of potential side effects, it's crucial to tailor dementia treatment to individual patients, taking into account their other health conditions and therapies. The impact on heart function, drug elimination, and other interactions should be evaluated individually. Medications like acetylcholinesterase inhibitors (AChEIs) and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine have been available in the US for over ten years for symptomatic relief. Approval of novel anti-amyloid biologics, which are 'disease-modifying,' with novel targeted mechanisms of action, has led to significant improvements from the traditional symptomatic treatment regime. With an improved pathological understanding of Alzheimer's and the discovery of new therapeutic targets, novel monoclonal antibodies have been approved in the last couple of years. In June 2021, Biogen and Eisai's ADUHELM (aducanumab) received accelerated approval, and in July 2023 LEQEMBI (lecanemab) received the full US FDA approval. Learn more about the FDA-approved Alzheimer's disease drugs @ Drugs for Alzheimer's Disease Treatment Biogen and Eisai's ADUHELM was granted accelerated approval by the FDA for treating early Alzheimer's disease, including mild cognitive impairment due to Alzheimer's. It is the first treatment to target amyloid β plaques and address Alzheimer's pathology. However, the drug is not widely available since it hasn't received traditional approval in the US and was rejected in Europe and Japan, tempering expectations for its success. LEQEMBI (lecanemab), another drug by Biogen and Eisai, received accelerated approval from the US FDA in January 2023. By July 2023, this approval was upgraded to a traditional one following a confirmatory trial that demonstrated a 27% slowing in decline, confirming the drug's clinical benefits. This achievement is a significant milestone, addressing the unmet needs of patients with early Alzheimer's and paving the way for future biologics and drugs targeting the disease's underlying pathology. This approval is advantageous for Biogen and Eisai, ensuring their profitability, and first-mover market advantage, and helping them recover from the ADUHELM setback. Moreover, after declining Eli Lilly's Alzheimer's drug donanemab for accelerated approval last year, the agency has now granted the anti-amyloid therapy full approval. This makes it a competitor to Eisai and Biogen's LEQEMBI. The FDA has approved donanemab-abzt, branded as KISUNLA, for treating adults with early symptomatic Alzheimer's disease, which includes individuals with mild cognitive impairment and those in the early stages of dementia. KISUNLA, administered monthly, stands as the pioneering treatment directed at amyloid plaques, backed by evidence allowing for cessation upon plaque removal. This approach aims to reduce treatment expenses and minimize infusion frequency. To know more about Alzheimer's disease treatment options, visit @ New Treatment for Alzheimer's Disease The Alzheimer's disease market is crowded with so many companies including BioVie, AB Science, Cassava Sciences, TauRx Therapeutics, Novo Nordisk, Eli Lilly, Athira Pharma, Alzheon, Eisai, and others are running clinical trials to improve the treatment space. The Alzheimer's disease pipeline possesses potential drugs in mid-stage developments to be launched shortly. Some of the promising drugs in the pipeline include NE3107, masitinib (AB1010), simufilam (PTI-125), Hydromethylthionine mesylate (TRx0237), semaglutide (NN6535), remternetug, fosgonimeton (ATH-1017), ALZ-801 (valiltramiprosate), E2814, and others that hold the potential to create a significant positive shift in the Alzheimer's disease market size. Discover which therapies are expected to grab major Alzheimer's disease market share @ Alzheimer's Disease Market Report BioVie's NE3107 is an orally administered small molecule that can penetrate the blood-brain barrier. It acts as an anti-inflammatory and insulin sensitizer by binding to extracellular signal-regulated kinase (ERK), selectively inhibiting inflammation. NE3107 blocks the activation of ERK/NFkB and the production of TNF triggered by inflammatory stimuli like lipopolysaccharide. BioVie is developing NE3107 for the treatment of Parkinson's disease, multiple myeloma, and prostate cancer. Despite Phase III results not meeting the primary efficacy endpoint due to exclusions, the trial's adaptive design allows continued patient enrollment to achieve statistical significance for regulatory approval. Based on promising efficacy signals from the trial, BioVie plans to collaborate with the US FDA to achieve this goal, aiming for a global launch by 2026. AB Science's Masitinib (AB1010) is an oral tyrosine kinase inhibitor designed to target activated cells of the neuro-immune system, specifically mast cells and microglia, which can accumulate within the central nervous system (CNS) at effective therapeutic levels. Research increasingly links mast cells and microglia to the pathophysiology of Alzheimer's disease. Evidence suggests that Masitinib may offer therapeutic benefits in treating patients with mild-to-moderate Alzheimer's disease, as demonstrated in a Phase II study. AB Science is currently conducting a Phase III trial to further confirm these findings. Cassava Sciences' Simufilam (PTI-125) is a small-molecule drug candidate designed to bind and reverse an altered form of the scaffolding protein filamin A (FLNA), which plays a crucial role in regulating the actin cytoskeleton in the brains of Alzheimer's disease patients. Administered orally, simufilam enhances the function of multiple brain receptors and exhibits potent anti-neuroinflammatory effects. Cassava Sciences is currently conducting Phase III clinical trials to evaluate simufilam tablets for Alzheimer's disease, with enrollment completed for both studies. The company expects to release top-line data by the end of 2024 for the first study and by mid-2025 for the second study. Discover more about drugs for Alzheimer's disease in development @ Alzheimer's Disease Clinical Trials The anticipated launch of these emerging therapies for Alzheimer's disease are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Alzheimer's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for Alzheimer's disease is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Alzheimer's disease market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Alzheimer's Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the Alzheimer's disease country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The Alzheimer's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Alzheimer's Disease Age-specific Cases of Alzheimer's Disease Gender-specific Cases of Alzheimer's Disease Severity-specific Cases of Alzheimer's Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Alzheimer's disease market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this Alzheimer's disease market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the Alzheimer's disease market. Also, stay abreast of the mitigating factors to improve your market position in the Alzheimer's disease therapeutic space. Related Reports Alzheimer's Disease Epidemiology Alzheimer's Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted Alzheimer's disease epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan. Alzheimer's Disease Pipeline Alzheimer's Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Alzheimer's Disease companies, including Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Psychosis in Parkinson's and Alzheimer's Disease Market Psychosis in Parkinson's and Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis in Parkinson's and Alzheimer's disease companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Drug ApprovalPhase 3Phase 2

100 Deals associated with Cerecin, Inc.

100 Translational Medicine associated with Cerecin, Inc.

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Pipeline Snapshot as of 14 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Tricaprylin	Alzheimer Disease More	Phase 3
CER-022	Neoplasms More	Preclinical
CER-081	Nervous System Diseases More	Preclinical
AC-0523	Huntington Disease More	Pending
AC-8632 ( ACC )	Parkinson Disease More	Pending

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