Latest news with #Prothena
Yahoo
5 days ago
- Business
- Yahoo
Novo Nordisk to advance ATTR amyloidosis mAb to Phase III
Novo Nordisk will advance its acquired ATTR amyloidosis with cardiomyopathy monoclonal antibody (mAb) to Phase III trials. The Danish pharma said that the Phase II trial of coramitug (PRX004), an mAb designed to deplete amyloid deposits, was 'successfully completed'. The trial investigated the efficacy and safety of once-monthly intravenous (IV) doses of coramitug compared to placebo in 105 patients with ATTR-cardiomyopathy. The primary endpoints of the trial included the functional endpoints of a six-minute walking test (6MWT), as well as a change in NT-proBNP after 52 weeks of treatment. While data has not yet been released, Novo Nordisk said results will be available at a medical conference later this year. However, the drugmaker confirmed its intention to initiate a Phase III trial of the drug in ATTR with cardiomyopathy before the end of 2025 in its Q2 2025 earnings call on 6 August. The news will be a welcome financial development for Prothena Corporation after the drug was acquired from them by Novo Nordisk in July 2021. Under the agreement, Prothena is eligible to receive up to $1.2bn upon achievement of clinical development and sales milestones, including the $100m earned to date. While NovoNordisk stocks have dropped on 6 August, in part due to the Q2 and H1 earnings announcement, Prothena's stock has risen slightly on the news, up from $7.03 at market close on 5 August to $7.45 at market open on 6 August – a 5.97% rise. Prothena's CEO Dr Gene Kinney said: 'We are excited by Novo Nordisk's decision to advance coramitug into Phase III development. There remains a significant unmet need in patients with ATTR amyloidosis with cardiomyopathy, who are at high risk for early mortality and significant morbidity due to amyloid deposition in vital organs.' ATTR successes and failures In May 2025, Prothena faced a trial setback after a Phase III study of birtamimab in patients with amyloid light-chain (AL) amyloidosis missed its primary endpoint. During the same month, Intellia Therapeutics' stock crashed after a serious adverse event (AE) in a Phase III trial of its ATTR cardiomyopathy gene therapy. Despite this event, trials of the therapy are ongoing. US biopharma Alnylam is celebrating a recent win, however, after its ATTR cardiomyopathy drug Amvuttra (vutrisiran) gained approval by the European Commission on 11 June. This came three months after the therapy got the green light from the US Food and Drug Administration (FDA) in March 2025. Other approved therapies include Pfizer's Vyndamax (tafamidis) and BridgeBio Pharma's Attruby (acoramidis). After the EC approval of Amvuttra, GlobalData cardiovascular and metabolic diseases analyst Costanza Alciati said the approval marked a change in the treatment paradigm for these patients, with therapies such as coramitug and ALXN2220 also set to have an impact. "Novo Nordisk to advance ATTR amyloidosis mAb to Phase III " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Malaysian Reserve
28-07-2025
- Business
- Malaysian Reserve
Alpha-synuclein Inhibitors Market to Witness Strong CAGR Through 2034, Driven by Advances in Neurodegenerative Therapies
No alpha-synuclein inhibitors are approved, underscoring a major need for therapies that slow or halt Parkinson's progression. Developing safe, brain-penetrant drugs that target toxic alpha-synuclein while preserving normal function is vital for early intervention and better outcomes. Late-stage candidates like Buntanetap (Annovis Biopharm), Prasinezumab (Roche/Prothena), and Amlenetug (Lundbeck) highlight growing innovation and competition in the alpha-synuclein inhibitors market. LAS VEGAS, July 28, 2025 /PRNewswire/ — DelveInsight's Alpha-synuclein Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging alpha-synuclein inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Alpha-synuclein Inhibitors Market Report As per DelveInsight's analysis, the total market size of alpha-synuclein inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others. Leading alpha-synuclein inhibitors companies, such as Annovis Biopharm, Lundbeck, Roche, Prothena, and others, are developing novel alpha-synuclein inhibitors that can be available in the alpha-synuclein inhibitors market in the coming years. Some of the key alpha-synuclein inhibitors in the pipeline include Buntanetap, Amlenetug, Prasinezumab, and others. In March 2025, Annovis Bio participated in AD/PD 2025, scheduled from April 1–5 in Vienna. During the conference, the company Annovis gave two presentations, showcasing findings from its Phase III Parkinson's disease trial and data on buntanetap in ApoE4 carriers from its Phase II/III Alzheimer's disease study. In February 2025, the FDA granted Fast Track Designation (FTD) to amlenetug for the treatment of MSA. In January 2025, Annovis Bio secured a significant milestone with the issuance of a US patent protecting its novel methods for treating and preventing acute brain and nerve injuries through buntanetap. Discover which indication is expected to grab the major alpha-synuclein inhibitors market share @ Alpha-synuclein Inhibitors Market Report Alpha-synuclein Inhibitors Market Dynamics The alpha-synuclein inhibitors market is driven by the growing prevalence of neurodegenerative disorders such as Parkinson's disease, Lewy body dementia, and multiple system atrophy, where alpha-synuclein aggregation plays a critical pathogenic role. With the global burden of Parkinson's disease expected to double by 2040, there is a pressing demand for disease-modifying therapies that can go beyond symptomatic relief. Current treatment options, such as dopaminergic drugs, primarily address motor symptoms but fail to halt disease progression. This unmet medical need is pushing pharmaceutical and biotechnology companies to focus on alpha-synuclein inhibitors, which target the underlying pathology by preventing protein misfolding, aggregation, and the subsequent neurodegenerative cascade. Significant research and development investments are shaping the competitive landscape of the alpha-synuclein inhibitors market. Several leading pharmaceutical players are actively pursuing monoclonal antibodies and small molecule inhibitors targeting alpha-synuclein. Clinical trials have advanced the understanding of the therapeutic potential of targeting alpha-synuclein, though some setbacks have been observed due to limited clinical efficacy in late-stage trials. Nonetheless, advancements in biomarker discovery and imaging technologies for early diagnosis and monitoring disease progression are expected to enhance the success rate of ongoing and future clinical programs. Market dynamics are also influenced by regulatory and reimbursement factors. Given the high cost and complexity of neurodegenerative disease drug development, regulatory agencies like the FDA and EMA are encouraging accelerated pathways and breakthrough therapy designations for promising candidates. However, high development costs, combined with stringent clinical efficacy requirements, pose challenges for new entrants and smaller biotech firms. Moreover, reimbursement policies in major markets will play a critical role in determining the commercial success of these therapies once approved. Collaborations and strategic partnerships are increasingly shaping the alpha-synuclein inhibitors landscape. Big pharmaceutical companies are entering licensing agreements, mergers, or co-development partnerships with biotech firms to expand their neurodegenerative pipelines. For instance, Roche and Prothena's collaboration on prasinezumab reflects the industry trend of leveraging external innovation to accelerate drug development. Furthermore, increasing venture capital funding and public-private initiatives are supporting the growth of innovative startups working on novel alpha-synuclein-targeting approaches, such as antisense oligonucleotides and gene therapy-based strategies. Looking ahead, the alpha-synuclein inhibitors market is poised for steady growth. The next decade is expected to witness significant milestones in the approval and commercialization of disease-modifying therapies, which could revolutionize the treatment paradigm for Parkinson's and related disorders. Alpha-synuclein Inhibitors Treatment Market Alpha-synuclein inhibitors are therapeutic agents developed to prevent the aggregation of alpha-synuclein, a protein closely linked to neurodegenerative disorders such as Parkinson's disease, Lewy body dementia, and multiple system atrophy. These inhibitors function by blocking protein misfolding, reducing toxic buildup, and promoting clearance pathways. By targeting alpha-synuclein pathology, they aim to slow the progression of these diseases, offering promising advancements in neuroprotection and symptom relief. Although no alpha-synuclein inhibitors have yet received regulatory approval, the FDA has issued a 'Letter of Support' encouraging the use of the synuclein-based biomarker, αSyn-SAA, in clinical trials for Parkinson's disease and related disorders. This recognition underscores the biomarker's potential to improve disease monitoring, streamline drug development, and refine treatment strategies. With no approved therapies in this category, several companies, including Annovis Bio, Roche/Prothena, and Lundbeck, are actively progressing their pipelines to develop innovative candidates. These initiatives aim to enhance therapeutic approaches, improve drug effectiveness, and address the significant unmet needs in neurodegenerative conditions such as Parkinson's, Lewy body dementia, and MSA. Learn more about the alpha-synuclein inhibitors @ Alpha-synuclein Inhibitors Analysis Key Emerging Alpha-synuclein Inhibitors and Companies Emerging alpha-synuclein inhibitors in the pipeline, including buntanetap (Annovis Biopharm), prasinezumab (Roche/Prothena), amlenetug (Lundbeck), and others, are showing promise for expanding treatment options. Buntanetap, formerly known as Posiphen or ANVS401, works against neurodegeneration by preventing the build-up of toxic proteins such as amyloid beta, tau, alpha-synuclein, and TDP43. This action helps boost synaptic function, improve axonal transport, and reduce neuroinflammation—key processes required to maintain healthy neurons. The accumulation of these proteins disrupts neural pathways, leading to neuronal damage and cell death, which underlie diseases like Alzheimer's and Parkinson's. By targeting these mechanisms, buntanetap aims to reverse neurodegeneration, restore brain function, and significantly enhance patients' quality of life. In March 2025, Annovis Bio participated in the AD/PD 2025 conference (April 1–5, Vienna), where it delivered two presentations highlighting data from its Phase III Parkinson's disease trial and findings on buntanetap in ApoE4 carriers from its Phase II/III Alzheimer's disease study. Earlier, in July 2024, Annovis announced results from its Phase III Parkinson's disease trial (NCT05357989). Among patients diagnosed with Parkinson's for over three years, buntanetap demonstrated significant improvements in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores, Parts II, III, II+III, and Total, compared with placebo and baseline. Prasinezumab, an experimental monoclonal antibody, is designed to selectively bind aggregated alpha-synuclein (α-syn) and reduce its neurotoxic effects. By targeting α-syn accumulation and its cell-to-cell spread, prasinezumab has the potential to slow disease progression. Targeting α-syn aggregates is supported by extensive research as a viable therapeutic strategy for Parkinson's disease. At the AD/PD 2025 conference, the company presented results from the Phase IIb PADOVA study. While the drug showed potential in slowing motor symptom progression, it did not achieve statistical significance in the primary analysis, and further evaluations are ongoing. Amlenetug, a human monoclonal antibody, is designed to bind all major extracellular forms of α-syn, preventing their uptake and halting aggregation seeding. Its active Fc region may promote immune-mediated clearance of α-syn/antibody complexes through microglial uptake, thereby reducing pathological deposits. Developed by Lundbeck in collaboration with Genmab A/S, amlenetug is part of ongoing efforts to develop disease-modifying therapies for neurodegenerative conditions. In February 2025, the FDA granted Fast Track Designation (FTD) for amlenetug in treating multiple system atrophy (MSA). It previously received Orphan Drug Designation (ODD) from the FDA in April 2024, SAKIGAKE designation from Japan's Ministry of Health, Labour and Welfare in March 2023, and ODD from the European Medicines Agency (EMA) in May 2021. The anticipated launch of these emerging therapies are poised to transform the alpha-synuclein inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the alpha-synuclein inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about alpha-synuclein inhibitors clinical trials, visit @ Alpha-synuclein Inhibitors Treatment Alpha-synuclein Inhibitors Overview Alpha-synuclein is a highly soluble and intrinsically disordered protein that accumulates in Lewy bodies and Lewy neurites, playing a key role in the development of Parkinson's disease and other synucleinopathies. While predominantly located in the brain, smaller amounts are also present in the heart, muscles, and various tissues. Within neurons, α-Syn is concentrated in presynaptic terminals, where it regulates synaptic vesicle dynamics. Studies indicate that it may restrict vesicle mobility, thereby influencing synaptic recycling and neurotransmitter release. Another view suggests that α-Syn interacts with VAMP2 (synaptobrevin) to stabilize SNARE complexes, with recent research linking these interactions to synaptic function. Moreover, α-Syn may modulate dopamine release, affecting both voluntary and involuntary motor control. Synucleinopathies are marked by the accumulation of α-Syn amyloid deposits in the brain, driving neurodegeneration. Preventing α-Syn aggregation remains challenging due to its inherently disordered structure and the complex, unpredictable nature of fibrillogenesis. Nevertheless, targeting α-Syn is considered a promising therapeutic strategy, offering potential avenues for the treatment of Parkinson's disease and related conditions. Alpha-synuclein Inhibitors Epidemiology Segmentation The alpha-synuclein inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for Alpha-synuclein Inhibitors Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors Alpha-synuclein Inhibitors Report Metrics Details Study Period 2020–2034 Alpha-synuclein Inhibitors Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report Parkinson's disease, Alzheimer's disease, Lewy body dementia, Multiple system atrophy, and others Key Alpha-synuclein Inhibitors Companies Annovis Biopharm, Lundbeck, Roche, Prothena, and others Key Alpha-synuclein Inhibitors Buntanetap, Amlenetug, Prasinezumab, and others Scope of the Alpha-synuclein Inhibitors Market Report Alpha-synuclein Inhibitors Therapeutic Assessment: Alpha-synuclein Inhibitors current marketed and emerging therapies Alpha-synuclein Inhibitors Market Dynamics: Conjoint Analysis of Emerging Alpha-synuclein Inhibitors Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Alpha-synuclein Inhibitors Market Access and Reimbursement Discover more about alpha-synuclein inhibitors in development @ Alpha-synuclein Inhibitors Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Key Events 5 Market Forecast Methodology 6 Alpha-synuclein Inhibitors Market Overview at a Glance in the 7MM 6.1 Market Share (%) Distribution by Indication in 2024 6.2 Market Share (%) Distribution by Indication in 2034 7 Alpha-synuclein Inhibitors: Background and Overview 7.1 Introduction 7.2 Evolution of Alpha-synuclein Inhibitors 7.3 Treatment 8 Target Patient Pool 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.3 Epidemiology Scenario in the 7MM 8.3.1 Total Cases in Selected Indications for Alpha-synuclein Inhibitors in the 7MM 8.3.2 Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in the 7MM 8.3.3 Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in the 7MM 8.4 The US 8.4.1 Total Cases in Selected Indications for Alpha-synuclein Inhibitors in the US 8.4.2 Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in the US 8.4.3 Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in the US 8.5 EU4 and the UK 8.5.1 Total Cases in Selected Indications for Alpha-synuclein Inhibitors in EU4 and the UK 8.5.2 Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in EU4 and the UK 8.5.3 Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in EU4 and the UK 8.6 Japan 8.6.1 Total Cases in Selected Indications for Alpha-synuclein Inhibitors in Japan 8.6.2 Total Eligible Patient Pool in Selected Indications for Alpha-synuclein Inhibitors in Japan 8.6.3 Total Treated Cases in Selected Indications for Alpha-synuclein Inhibitors in Japan 9 Emerging Therapies 9.1 Key Cross Competition 9.2 Buntanetap: Annovis Biopharma 9.2.1 Drug Description 9.2.2 Others Developmental Activities 9.2.3 Clinical Trials Information 9.2.4 Safety and Efficacy 9.2.5 Analyst's View 9.3 Prasinezuma: Roche/Prothena 9.4 Amlenetug: Lundbeck List of drugs to be continued in the final report… 10 Alpha-synuclein Inhibitors: the 7MM Analysis 10.1 Key Findings 10.2 Key Market Forecast Assumptions 10.2.1 Cost Assumptions and Rebates 10.2.2 Pricing Trends 10.2.3 Analogue Assessment 10.2.4 Launch Year and Therapy Uptakes 10.3 Market Outlook 10.4 Attribute Analysis 10.5 Total Market Size of Alpha-synuclein Inhibitors in the 7MM 10.6 The US Market Size 10.6.1 Total Market Size of Alpha-synuclein Inhibitors in the US 10.6.2 Market Size of Alpha-synuclein Inhibitors by Therapies in the US 10.7 EU4 and the UK Market Size 10.7.1 Total Market Size of Alpha-synuclein Inhibitors in EU4 and the UK 10.7.2 Market Size of Alpha-synuclein Inhibitors by Therapies in EU4 and the UK 10.8 Japan Market Size 10.8.1 Total Market Size of Alpha-synuclein Inhibitors in Japan 10.8.2 Market Size of Alpha-synuclein Inhibitors by Therapies in Japan 11 Unmet Needs 12 SWOT Analysis 13 KOL Views 14 Market Access and Reimbursement 14.1 The US 14.2 EU4 and the UK 14.3 Japan 15 Bibliography 16 Report Methodology Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 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 Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 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 Alzheimer's disease companies including AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio, Inc., Anavex Life Sciences Corp., Annovis Bio, Inc., Cerecin, BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Neurim Pharmaceuticals, Suven Life Sciences, Bristol-Myers Squibb, Karuna Therapeutics, T3D Therapeutics, Inc., Lexeo Therapeutics, Axsome Therapeutics, Inc., Araclon Biotech S.L., Eisai Co., Ltd., TauRx Therapeutics, TrueBinding, Inc., AC Immune SA, Johnson & Johnson, Longeveron Inc., Vaccinex Inc., IGC Pharma LLC, among others. Multiple System Atrophy Market Multiple System Atrophy Market Insights, Epidemiology, and Market Forecast – 2034 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 MSA companies including H Lundbeck A/S, Brain Neurotherapy Bio, Inc., Asklepios BioPharmaceutical, Inc., Theravance Biopharma, Ono Pharmaceutical Co. Ltd, Ionis Pharmaceuticals, Inc., Biogen, Alterity Therapeutics, Teva Pharmaceutical, MODAG GmbH, among others. Lewy Body Dementia Market Lewy Body Dementia Market Insights, Epidemiology, and Market Forecast – 2034 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 Lewy body dementia companies including EIP Pharma Inc., Cognition Therapeutics, Eisai Inc., Sun Pharma Advanced Research Company Limited, Georgetown University, Eli Lilly and Company, CuraSen Therapeutics, Inc., Athira Pharma, Aptinyx 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 UsShruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
28-07-2025
- Business
- Yahoo
Prothena to Report Second Quarter 2025 Financial Results on August 4
DUBLIN, July 28, 2025--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that it will report its second quarter and first six months of 2025 financial results on Monday, August 4, 2025, after the close of the U.S. financial markets. Consistent with past practice, the Company will not be conducting a conference call in conjunction with the financial results release on August 4. About Prothena Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including ATTR amyloidosis with cardiomyopathy, Alzheimer's disease, Parkinson's disease and a number of other neurodegenerative diseases. For more information, please visit the Company's website at and follow the Company on X (formerly Twitter) @ProthenaCorp. View source version on Contacts Mark Johnson, CFA, Vice President, Investor Relations650-417-1974,
Business Wire
28-07-2025
- Business
- Business Wire
Prothena to Report Second Quarter 2025 Financial Results on August 4
DUBLIN--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that it will report its second quarter and first six months of 2025 financial results on Monday, August 4, 2025, after the close of the U.S. financial markets. Consistent with past practice, the Company will not be conducting a conference call in conjunction with the financial results release on August 4. About Prothena Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including ATTR amyloidosis with cardiomyopathy, Alzheimer's disease, Parkinson's disease and a number of other neurodegenerative diseases. For more information, please visit the Company's website at and follow the Company on X (formerly Twitter) @ProthenaCorp.
Associated Press
16-06-2025
- Business
- Associated Press
Prothena's Partner Roche to Advance Prasinezumab into Phase III Development for Early-Stage Parkinson's Disease
DUBLIN--(BUSINESS WIRE)--Jun 16, 2025-- Prothena Corporation plc (NASDAQ:PRTA) today announced partner Roche will advance prasinezumab, an investigational anti-alpha-synuclein antibody, into Phase III development in early-stage Parkinson's disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLE) from both PADOVA and the Phase II PASADENA study. 'As pioneers in developing the first anti-alpha-synuclein targeting antibody, we are excited to see Roche advancing prasinezumab into Phase III development, with the potential to deliver the first disease-modifying treatment option to the millions of individuals living with Parkinson's disease and their families,' stated Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson's disease. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance. Positive trends towards reduced motor progression at 104 weeks (two years) were observed; these effects appear to be sustained over longer treatment periods based on additional OLE data. The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology. The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson's disease, are ongoing. About Prasinezumab Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease. Data from the Phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early-stage Parkinson's disease. PADOVA investigated prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01], although the study missed statistical significance (p=0.0657). In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99], p=0.0431 (nominal). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Trends towards reduced motor progression at 104 weeks (two years) were observed, showing 30-40% relative reduction versus placebo across the overall and levodopa-treated populations. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The safety database for prasinezumab consists of data from more than 900 Parkinson's disease study participants that have been treated with the investigational medicine, of which more than 750 remain in open label treatment with over 500 treated for 1.5-5 years. In December 2013, Prothena and Roche entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including prasinezumab. Roche has sole responsibility for developing and commercializing prasinezumab and has agreed to pay Prothena up to double-digit teen royalties on net sales. To date, Prothena has earned $135 million with up to $620 million in additional milestone payments that include regulatory and sales milestones. In addition, Prothena has an option to co-promote prasinezumab in the U.S. About Parkinson's disease Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells. Today, Parkinson's disease affects over 10 million people worldwide. The prevalence of Parkinson's disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available. However, no therapies slow down or stop the clinical progression of Parkinson's disease. About Prothena Prothena Corporation plc is a clinical-stage biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including ATTR amyloidosis with cardiomyopathy, Alzheimer's disease, Parkinson's disease and a number of other neurodegenerative diseases. For more information, please visit the Company's website at and follow the Company on X (formerly Twitter) @ProthenaCorp. Forward-Looking Statements This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, design, and proposed mechanism of action prasinezumab; plans for ongoing and future clinical trials of prasinezumab; and amounts we might receive under our collaboration with Roche. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the 'Risk Factors' sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations. View source version on CONTACT: Media Michael Bachner, Senior Director, Corporate Communications 609-664-7308,[email protected] Mark Johnson, CFA, Vice President, Investor Relations 650-417-1974,[email protected] KEYWORD: EUROPE IRELAND UNITED KINGDOM INDUSTRY KEYWORD: HEALTH NEUROLOGY CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Prothena Corporation plc Copyright Business Wire 2025. PUB: 06/16/2025 01:06 AM/DISC: 06/16/2025 01:05 AM
