AbbVie, Inc.

Around 5.2 million adults in the UK have moderate to severe atopic dermatitis. Image credit: Shutterstock / Kmpzzz. England’s National Institute for Health and Care Excellence ( Nice ) has recommended Almirall ’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma ’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer , Eli Lilly, and AbbVie , respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of up to 4.4% among adults in the EU. In the UK alone, around 5.2 million adults have moderate to severe atopic dermatitis. See Also: Dupixent “addresses current gap” in COPD biologics landscape Peltopepimut-s by ISA Pharmaceuticals for Cervical Cancer: Likelihood of Approval Ebglyss, which was approved in Europe in October 2023, and then two months later in the UK, works by inhibiting interleukin-13 (IL-13) signalling. IL-13 pathways play an important role in inflammation, driving the type-2 inflammatory loop in the skin. Adbry similarly targets IL-13 while Dupixent inhibits IL-13 and IL-4. The National Eczema Society’s chief executive Andrew Proctor said: “It’s important we have a range of treatment options, so patients have the chance to access a treatment that works well for them.” Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. By 2030, the drug is predicted to generate nearly $3.4bn in global sales. GlobalData is the parent company of Pharmaceutical Technology. Amid Sanofi and Regeneron’s Dupixent dominance , Johnson & Johnson (J&J) made a play for the atopic dermatitis space earlier this year when it spent $1.25bn to acquire Numab Therapeutics’ antibody NM26 in May.

Flush with €63 million ($68 million) from an upsized series A funding, SciRhom is looking to challenge conventional wisdom in autoimmune disease treatment. The investment will support clinical development of the company's lead antibody candidate SR-878, which is directed against a protein many experts initially dismissed as an improbable therapeutic target.The oversubscribed round was co-led by Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital, and Wellington Partners, with participation from new investor Bayern Kapital and existing backers including High-Tech Gründerfonds and PhiFund Ventures.Selective antibody approachSciRhom's approach focuses on iRhom2, a key regulator of TACE (also known as ADAM17), which plays a central role mediating major inflammatory signaling pathways like TNF-alpha, IL-6 and EGFR. For a long time, iRhom2 was thought to function exclusively inside cells and was therefore considered unsuitable for therapeutic antibodies. However, SciRhom co-founder Carl Blobel's work indicated it might actually be accessible on the cell surface, making it a potential antibody target after all.There have also been numerous attempts in the past to block TACE directly with small-molecule inhibitors – Pfizer/Wyeth's apratastat, Bristol Myers Squibb's DPC 333 and Incyte's INCB7839 were among the most studied, although all three ultimately failed. These drugs, chief operating officer Jens Ruhe told FirstWord, not only targeted TACE, but also interfered with closely related proteins."This sort of unspecificity was associated with additional side effects such as liver toxicity in one case or thrombosis…. One molecule was not effective at all," Ruhe said. "So this is being overcome with the fact that we have highly selective antibodies, which we tested in multiple preclinical screens, really only to interfere with iRhom2 itself and nothing else."The idea is to block only those aspects of TACE biology that are tied to disease-driving pathways, while at the same time preserving other vital functions that rely on TACE signaling.Dosing start in a few weeksSR-878 is poised to enter clinical testing in the coming weeks. "We actually have all the necessary regulatory approvals," said CEO Jan Poth. "It will be basically a standard single ascending dose trial in healthy volunteers. As usual, you want to see what the pharmacokinetics are of your drug in humans… and you certainly also want to get a first indication of the safety."If all goes well, the company is looking to move into Phase II "in the later second half of next year," he said.While the initial focus will be on rheumatoid arthritis and inflammatory bowel disease, based on positive preclinical data, the company sees room for eventual expansion. According to Poth, iRhom2 "is such a central mechanism in quite a number of autoimmune diseases that this is basically a pipeline in a molecule," along the lines of other immunological drugs like TNF inhibitors and AbbVie's anti-IL-23 antibody Skyrizi (risankizumab).SciRhom's early insight has also allowed the company, which was founded in 2016, to build up a solid patent portfolio around iRhom2-targeting therapies. Poth noted that with no existing patents on iRhom2, SciRhom had a "green field" to strategically secure patents, resulting in "a very strong patent portfolio covering that space."Looking ahead, the CEO acknowledged the significant funding required to fully develop SR-878 across multiple indications. "We can easily go up into the hundreds of millions, which you will need in order to bring it fully fledged to the market in all the possible indications. That is something which will definitely need more money than we have. So there will be different ways of how that can be approached by partnerships, by licensing, by an IPO. Nothing is fully decided yet,” he added.

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