Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)

The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.

Start Date07 Oct 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT05738486 / Active, not recruitingPhase 3

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Start Date28 Feb 2023

Sponsor / Collaborator

Eli Lilly & Co.

NCT05508789 / RecruitingPhase 3

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Start Date10 Oct 2022

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Donanemab-AZBT

100 Translational Medicine associated with Donanemab-AZBT

100 Patents (Medical) associated with Donanemab-AZBT

118

Literatures (Medical) associated with Donanemab-AZBT

31 Dec 2024·mAbs

Single domain antibody-scFv conjugate targeting amyloid β and TfR penetrates the blood–brain barrier and interacts with amyloid β

Article

Author: Eriksson, Jonas ; Sjöström, Elisabet O. ; Dallas, Tiffany ; Sehlin, Dag ; Berglund, Magnus M. ; Syvänen, Stina ; Faresjö, Rebecca

Neurodegenerative diseases such as Alzheimer's disease (AD) pose substantial challenges to patients and health-care systems, particularly in countries with aging populations. Immunotherapies, including the marketed antibodies lecanemab (Leqembi®) and donanemab (Kisunla^TM), offer promise but face hurdles due to limited delivery across the blood-brain barrier (BBB). This limitation necessitates high doses, resulting in increased costs and a higher risk of side effects. This study explores transferrin receptor (TfR)-binding camelid single-domain antibodies (VHHs) for facilitated brain delivery. We developed and evaluated fusion proteins (FPs) combining VHHs with human IgG Fc domains or single-chain variable fragments (scFvs) of the anti-amyloid-beta (Aβ) antibody 3D6. In vitro assessments showed varying affinities of the FPs for TfR. In vivo evaluations indicated that specific VHH-Fc and VHH-scFv fusions reached significant brain concentrations, emphasizing the importance of optimal TfR binding affinities. The VHH-scFv fusions were further investigated in mouse models with Aβ pathology, showing higher retention compared to wild-type mice without Aβ pathology. Our findings suggest that these novel VHH-based FPs hold potential for therapeutic and diagnostic applications in AD, providing a strategy to overcome BBB limitations and enhance brain targeting of antibody-based treatments. Furthermore, our results suggest that a given bispecific TfR-binding fusion format has a window of "optimal" affinity where parenchymal delivery is adequate, while blood pharmacokinetics aligns with the desired application of the fusion protein.

01 Dec 2024·Neurology and Therapy

Estimating the Economically Justifiable Price of Limited-Duration Treatment with Donanemab for Early Symptomatic Alzheimer’s Disease in the United States

Article

Author: Boustani, Malaz ; Doty, Erin G ; Murphy, Daniel R ; Klein, Timothy M ; Johnston, Joseph A ; Garrison, Louis P ; Smolen, Lee J ; Spargo, Andrew W ; Belger, Mark

INTRODUCTION:

The goal of this economic model is to estimate an economically justifiable price (EJP) for using donanemab for the treatment of early symptomatic Alzheimer's disease (AD) in the United States based on clinical data from the phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511).

METHODS:

We adapted an AD Markov state-transition model developed by the Institute for Clinical and Economic Review to estimate the EJP for donanemab at different willingness-to-pay (WTP) thresholds from the health care system perspective and the societal perspective as co-base cases.

RESULTS:

Assuming a WTP threshold of $150,000 per quality-adjusted life-year (QALY) gained, the model estimates a 1-year (13-dose) EJP for donanemab of $80,538 from the health care system perspective and $91,126 from the societal perspective; at a WTP threshold of $100,000 per QALY gained, the model estimates a 1-year (13-dose) EJP for donanemab of $44,691 from the health care system perspective and $55,419 from the societal perspective. Mean total treatment costs per patient at the $150,000 per QALY gained EJP derived from the health care system perspective were estimated at $77,812 based on the average number of doses of donanemab patients received in the co-base case analysis. One-way sensitivity analysis (OWSA) indicated that treatment efficacy, disease severity at the time of treatment initiation, and duration of treatment effect were the main drivers of the potential EJP.

CONCLUSIONS:

Results from this modeling simulation informed by the TRAILBLAZER-ALZ 2 study support an EJP for limited-duration treatment with donanemab that exceeds per-dose list prices for currently available amyloid-targeting therapies, implying potentially lower lifetime costs and better value for money.

01 Dec 2024·Life Science Alliance

Metabolic resistance of Aβ3pE-42, a target epitope of the anti-Alzheimer therapeutic antibody, donanemab

Article

Author: Fujioka, Ryo ; Watamura, Naoto ; Saido, Takaomi C ; Mann, David MA ; Mihira, Naomi ; Sekiguchi, Misaki ; Iwata, Nobuhisa ; Shirotani, Keiro ; Morito, Takahiro ; Kamano, Naoko ; Kakiya, Naomasa ; Tsubuki, Satoshi ; Hashimoto, Shoko ; Watanabe-Iwata, Kaori ; Higuchi, Makoto ; Matsuba, Yukio ; Sasaguri, Hiroki ; Saito, Takashi ; Robinson, Andrew C ; Takamura, Risa

The amyloid β peptide (Aβ), starting with pyroglutamate (pE) at position 3 and ending at position 42 (Aβ3pE-42), predominantly accumulates in the brains of Alzheimer’s disease. Consistently, donanemab, a therapeutic antibody raised against Aβ3pE-42, has been shown to be effective in recent clinical trials. Although the primary Aβ produced physiologically is Aβ1-40/42, an explanation for how and why this physiological Aβ is converted to the pathological form remains elusive. Here, we present experimental evidence that accounts for the aging-associated Aβ3pE-42 deposition: Aβ3pE-42 was metabolically more stable than other Aβx-42 variants; deficiency of neprilysin, the major Aβ-degrading enzyme, induced a relatively selective deposition of Aβ3pE-42 in both APP transgenic andAppknock-in mouse brains; Aβ3pE-42 deposition always colocalized with Pittsburgh compound B–positive cored plaques in APP transgenic mouse brains; and under aberrant conditions, such as a significant reduction in neprilysin activity, aminopeptidases, dipeptidyl peptidases, and glutaminyl-peptide cyclotransferase-like were up-regulated in the progression of aging, and a proportion of Aβ1-42 may be processed to Aβ3pE-42. Our findings suggest that anti-Aβ therapies are more effective if given before Aβ3pE-42 deposition.

389

News (Medical) associated with Donanemab-AZBT

14 Nov 2024

·www.drugs.com

New Alzheimer's prevention trial receives $74.5 million NIH grant

PHOENIX, Nov. 14, 2024. A new Alzheimer's prevention study has received a $74.5 million five-year grant from the National Institute on Aging, part of the National Institutes of Health (NIH). The two-part study will be conducted in members of the world's largest autosomal dominant Alzheimer's disease (ADAD) kindred in Colombia who carry a genetic mutation that makes them all but destined to develop Alzheimer's and become cognitively impaired at an average age of 44. The study is led by Banner Alzheimer's Institute in Phoenix and the Neurosciences Group at the University of Antioquia (GNA) in Medellin, Colombia. It will initially aim to remove amyloid plaques as completely as possible in cognitively impaired and unimpaired carriers of the presenilin 1 (PSEN1) E280A mutation, and then evaluate different ways to stave off the recurrence of plaque deposits and other ensuing elements of the disease. Enrollment is expected to begin in the fall of 2025. The first part of the study will use Eli Lilly and Company's (Lilly) antibody therapy donanemab to remove existing plaques as completely as possible (i.e., to levels consistent with a negative amyloid PET scan). Donanemab has been shown to clear amyloid plaques and slow cognitive decline, and was recently approved by the U.S. Food and Drug Administration for use in patients with mild cognitive impairment and dementia due to Alzheimer's. The study will provide new information about the drug's safety, tolerability, and biological efficacy in the unimpaired and impaired stages of ADAD. The second part of the study will compare the following approaches in the same participants, for safety, tolerability and ability to avert amyloid plaque accumulation and other biological and clinical features of the disease: This study builds on the history, partnership, infrastructure and learnings of the original API ADAD Colombia Trial, which launched a new era in Alzheimer's prevention research when it was announced by NIH in 2012. While the investigational drug in the original trial with crenezumab failed to clear plaques or demonstrate a clinical benefit, the study introduced paradigms to speed up the evaluation of promising prevention therapies, found ways to do so in a vulnerable population in a developing country, and led to a growing number of prevention trials, some of which may find the first effective Alzheimer's prevention therapies within the next few years. Both the original and the new trial tap into GNA's identification of about 6,000 distant relatives from the Colombian PSEN1 E280A kindred, including about 1,200 who carry the ADAD-causing genetic mutation. "We are excited about the chance to advance the fight against Alzheimer's disease in partnership with our outstanding colleagues and these unique families in Colombia," said Robert Alexander, MD, the API's chief scientific officer and one of the prevention trial leaders. "This study will clarify the extent to which the antibody treatment reduces amyloid plaques in the unimpaired and impaired stages of ADAD and test different approaches to maintain low amyloid levels following plaque removal." The new study will enroll 200 cognitively unimpaired and mildly impaired mutation carriers and 40 non-carriers (who will receive placebo) from the Colombian kindred. "This trial is a testament to our dear friend and longstanding partner, Dr. Francisco Lopera, who established GNA, forged a close working relationship with API, and could not have been more committed to these families," said Eric M. Reiman, MD, executive director of Banner Alzheimer's Institute and one of the other API leaders. "He constantly said, 'My families are waiting,' and he played indispensable roles in the effort to find effective prevention therapies." "I am honored to follow in Dr. Lopera's footsteps and continue our work with API," said David Aguillón, MD, GNA's new director and principal investigator of the University of Antioquia study site. "Dr. Lopera and the Antioquia families have inspired all of us to never give up, to maintain our sense of urgency to find effective Alzheimer's prevention therapies, and to do so in ways that will help our Antioquia families." The research study is supported by grant R01AG086363 from the NIH National Institute on Aging, the lead U.S. federal agency supporting and conducting Alzheimer's disease and related dementias research. Lilly and Roche are generously donating the drug supplies that will be evaluated in this study. The study is led by Drs. Robert Alexander, Eric Reiman and Jessica Langbaum from BAI and its API; David Aguillón from the University of Antioquia; and Yakeel Quiroz from the University of Antioquia and Massachusetts General Hospital. API also received a $3 million grant from the Zurich-based NOMIS Foundation to continue to assess about 2,000 mutation carriers and non-carriers from the PSEN1 E280A kindred, provide a shared resource of longitudinal data and blood samples for the field, accelerate enrollment in the new prevention trial, and provide education and social support for the families irrespective of their participation in the study. About Banner Alzheimer's Institute Since its inception in 2006, Banner Alzheimer's Institute has sought to find effective Alzheimer's disease prevention therapies within twenty years, establish a new model of care for cognitively impaired patients and family caregivers, and forge new models of collaboration in biomedical research. It has made groundbreaking contributions to the unusually early detection, tracking, diagnosis, study and prevention of Alzheimer's disease. It includes the pioneering Alzheimer's Prevention Initiative, an extensive profile of research studies and clinical trials, comprehensive clinical, family and community service programs, leading brain imaging and blood-based biomarker research programs, and strategic partnerships with public and private research organizations around the world. About the Alzheimer's Prevention Initiative The Alzheimer's Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimer's prevention research. Led by Banner Alzheimer's Institute, the API conducts prevention trials in cognitively healthy people at increased risk for Alzheimer's disease. API continues to establish brain imaging, fluid biomarker and cognitive endpoints needed to rapidly test promising prevention therapies. It also leads participant recruitment registries to accelerate enrollment into Alzheimer's-focused studies. API is intended to provide the scientific means, accelerated approval pathway and enrollment resources needed to evaluate the range of promising Alzheimer's prevention therapies and find ones that work without losing another generation. For more information, go to alzheimerspreventioninitiative.com. About Grupo de Neurociencias de Antioquia Grupo de Neurociencias de Antioquia (GNA), at the University of Antioquia in Medellín, is ranked as one of the best research organizations in Colombia. For more than three decades, GNA has characterized what is now considered the world's largest population with early-onset familial Alzheimer's disease, and it continues to play pioneering roles in the effort to find effective Alzheimer's prevention therapies. GNA has also characterized large and paradigmatic populations with other forms of dementia and other neurogenetic disorders. SOURCE Banner Alzheimer's Institute Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalClinical Study

08 Nov 2024

·endpts.com

Eisai slashes Leqembi sales forecast by almost $100M

Eisai has slashed Leqembi’s sales forecast by 25% this year, lowering the ceiling for one of the industry’s most closely-watched drugs. The company now expects that the Alzheimer’s treatment will bring in 42.5 billion JPY ($278.3 million) in fiscal 2024, down from 56.5 billion JPY ($370.2 million). The downward revision is more pronounced in the US, where sales were expected to account for 77% of Leqembi’s revenue this year. Now, Eisai expects 26.5 billion JPY ($173.3 million) in US revenue, down from previous estimates of 43.5 billion JPY ($278.3 million). To meet the new projections, Eisai is still betting on considerable growth. Leqembi has generated 16.3 billion JPY ($106.9 million) since April 1 — the start of Eisai’s fiscal year — meaning the second half’s sales would have to grow 161% compared to the first half of the fiscal year. “Although there were some delays in the progression of sales results in the US, we believe that we are making a certain level of progress,” the company said Friday in its earnings presentation . It added that it has been “progressing with addressing current issues as well as initiatives to expand the near-future market.” The revised guidance didn’t seem to perturb investors, with Jefferies analysts writing that the new figures seem in line with consensus figures. Jefferies previously described the guidance that Leqembi would have $370 million in sales this year as “considerably higher” than the consensus estimates. US-listed shares of Eisai $ESAIY were generally flat by Friday afternoon. Prescription data show there are about 9,000 patients on Leqembi as of Oct. 24, compared to about 700 on Lilly’s Alzheimer’s treatment Kisunla, according to Jefferies. The latter was approved in July, about a year after Leqembi secured full approval. During an earnings call last month, Biogen CEO Chris Viehbacher said the company, which commercializes Leqembi with Eisai, and the Japanese drugmaker had learned “an awful lot” in the year since launching the drug. “We both understand that this is a very complicated launch,” he said. “I think more complicated than most that I’ve certainly seen, I think, most people have seen.” Still, he credited physicians for “putting an awful lot of work in to make all of this happen.”

Drug Approval

08 Nov 2024

·www.pharmaceutical-technology.com

Eisai lowers Leqembi revenue forecast after rocky entry to market

Leqembi is forecasted to make $4.2bn globally by 2030. Image credit: Shutterstock / viewimage. Eisai has lowered the sales forecast for its Alzheimer’s drug Leqembi (lecanemab), primarily citing delays in revenue in the US. The Japanese pharma expects its lead product co-developed with Biogen to generate $280m (Y42.5bn) in the second half of its 2024 fiscal year, down approximately $90m from the original $370m figure. Shares in the company opened 0.92% higher than the previous market close due to strong overall year-over-year revenue and gross profit, both up 103%. Revealing the company’s Q2 results on 8 November, Eisai’s CEO Haruo Naito highlighted a delay in the progression of sales results in the US as a key factor for Leqembi’s adjusted forecast. Eisai expects a 153% sales growth of the drug in the US from the first half of the fiscal year to the next, compared to a 184% increase in Japan. Leqembi’s launch in the US has been slow due to a variety of factors including regular infusion logistics and diagnosis constraints. Eisai estimates that 10,000 patients with Alzheimer’s disease are eligible for Leqembi, of which 4,000 have started treatment. Eisai stated it is “making a certain level of progress” and “progressing with addressing current issues as well as initiatives to expand the near-future market.” This includes a monthly intravenous (IV) version of Leqembi which will be reviewed by the US Food and Drug Administration (FDA) early next year. Eisai previously said that the new formulation will make treatment easier and less burdensome. Eisai did not immediately respond to Pharmaceutical Technology when asked for comment on the lowered Leqembi outlook. Whilst not mentioning regulatory updates in the UK, Eisai’s forecast revision comes just a few months after Leqembi was deemed too expensive for use by the National Health Service (NHS). Though licensed for use in the country, England’s National Institute for Health and Care Excellence (NICE) said at the time the benefits of the treatment were too small to justify its cost. Eli Lilly met the same fate with its Leqembi rival Kisunla (donanemab), which was also rejected for NHS use last month. In another setback, Leqembi failed to win over the European Medicines Agency (EMA) in July this year after a committee recommended against the therapy’s approval. Leqembi is a dual-acting monoclonal antibody designed to target and ablate amyloid beta aggregates that are a major driver of Alzheimer’s progression. Despite its rocky launch, GlobalData’s Pharma Intelligence Centre forecasts the treatment will make $4.2bn globally by 2030. GlobalData is the parent company of Pharmaceutical Technology .

Drug ApprovalAccelerated ApprovalBiosimilarFinancial StatementPhase 3

100 Deals associated with Donanemab-AZBT

External Link

KEGG	Wiki	ATC	Drug Bank
D11500	Donanemab-AZBT	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	GB	Eli Lilly & Co.	23 Oct 2024
Dementia due to Alzheimer's disease (disorder)	GB	Eli Lilly Nederland BV	23 Oct 2024
Mild cognitive disorder	GB	Eli Lilly Nederland BV	23 Oct 2024
Mild cognitive disorder	GB	Eli Lilly & Co.	23 Oct 2024
Alzheimer Disease	US	Eli Lilly & Co.	02 Jul 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psychotic Disorders	NDA/BLA	CA	Eli Lilly Canada, Inc.	-
Behavioural disorders	Phase 3	US	Eli Lilly & Co.	28 Feb 2023
Behavioural disorders	Phase 3	GB	Eli Lilly & Co.	28 Feb 2023
Neurocognitive Disorders	Phase 3	AR	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	AU	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	KR	Eli Lilly & Co.	10 Oct 2022
Neurocognitive Disorders	Phase 3	TW	Eli Lilly & Co.	10 Oct 2022
Cognitive Dysfunction	Phase 2	CA	Eli Lilly & Co.	23 Nov 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05738486 (TRAILBLAZER-ALZ 6, Company_Website) Manual	Phase 3	Alzheimer Disease	843	received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafter (Standard Dosing Regimen)	urxjiawzeg(vauovzqhxx) = ugizkactsa mepupqrzis (inanlcomny ) View more	Positive	29 Oct 2024
				received 1 vial (350 mg) of donanemab for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion, and four vials (1400 mg) per infusion thereafter (Modified Titration)	urxjiawzeg(vauovzqhxx) = diklkpzutw mepupqrzis (inanlcomny ) View more
NCT05567159 (CTgov)	Phase 1	-	42	Donanemab	gkjejjeuha(figlbkquzf) = xsckocmxff inebgonjjw (xesdpcpqov, vuxwrwrflm - xsvjewlrwh) View more	-	04 Oct 2024
NCT05533411 (CTgov)	Phase 1	-	36	Placebo (Placebo)	lwycxbmlce(dnxeyvcout) = jmjfuwtehp uyglyrokio (ftbvqrlaig, texfnwtjrf - lxgbvexnsq) View more	-	04 Oct 2024
				Donanemab (700 mg Donanemab)	lwycxbmlce(dnxeyvcout) = vqvvsvogib uyglyrokio (ftbvqrlaig, lkkbrmowor - uykcjxohvy) View more
NCT01837641 (CTgov)	Phase 1	Alzheimer Disease \| Cognitive Dysfunction	63	Placebo (Placebo IV)	lcypwqatqz(hepagnplfu) = bhjkqfnbft vsehqyutao (ujkttlgmus, frschdqxzu - vdtgttqnud) View more	-	04 Oct 2024
				LY3002813 (0.1 mg/kg / 0.3 mg/kg LY3002813 IV)	lcypwqatqz(hepagnplfu) = escewtiotr vsehqyutao (ujkttlgmus, zrqkfhcqjx - aoqytdquip) View more
NCT04437511 (FDA_CDER) Manual	Phase 3	Alzheimer Disease	1,736	KISUNLA	nfnwadewbo(euqtnebida): Difference = 2.92, P-Value = <0.0001 View more	Positive	02 Jul 2024
				Placebo
TRAILBLAZER-ALZ, TRAILBLAZER-ALZ2 (AAN2024)	Phase 2/3	number of microhemorrhages \| cortical superficial siderosis \| mean arterial pressure ... View more	2,031	Donanemab	ucyengvtuo(pokxohwrhv) = evipxypqzs fjmsfdcojv (wjnzbfpmsa )	Positive	09 Apr 2024
NCT05108922 (TRAILBLAZER-ALZ 4, CTgov)	Phase 3	Alzheimer Disease \| Mild cognitive disorder	148	Aducanumab (Aducanumab)	kobcwtyede(aukfdwufoi) = ewaqzsbcnh xrkckgrqoi (swoyljdndh, mtrcngixsi - puapwnzqec) View more	-	02 Nov 2023
				Donanemab (Donanemab)	kobcwtyede(aukfdwufoi) = psxgoikyrb xrkckgrqoi (swoyljdndh, zrnhmlzgmb - xxsdegdqbk) View more
NCT04437511 (TRAILBLAZER-ALZ 2, Pubmed) Manual	Phase 3	Alzheimer Disease	1,736	donanemab	kesdxjmjye(jrlhnoqjek) = oytiwtfpog lbzodkrsgt (mhcmdbufez, -7.01 to to 5.03) Met View more	Positive	17 Jul 2023
				placebo	kesdxjmjye(jrlhnoqjek) = mrceuazdmy lbzodkrsgt (mhcmdbufez, -10.23 to to 8.31) Met View more
TRAILBLAZER-ALZ-4 (AAN2023)	Phase 3	Alzheimer Disease	148	Donanemab	rxyzhgrofn(wekfjfcinq) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. irtyyqqkek (sczilunhyl )	-	25 Apr 2023
				Aducanumab
NCT05108922 (TRAILBLAZER-ALZ 4, Corporate Publications) Manual	Phase 3	Alzheimer Disease	130	Donanemab	kgwmpsstgf(urynfkmfmd) = oqbmngnupx rnmrushaid (vgycdbrngk ) View more	Superior	30 Nov 2022
				Aducanumab-avwa-avwa	kgwmpsstgf(urynfkmfmd) = ycaghqmlkl rnmrushaid (vgycdbrngk ) View more

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