Bepranemab
- Generic Name
- Bepranemab
- Drug Type
- Biotech
- CAS Number
- 2244960-75-4
- Unique Ingredient Identifier
- 9M1GV6L389
- Background
Bepranemab is a recombinant humanized Igg4P monoclonal antibody directed against human Tau.
UCB Showcases Promising Neurodegenerative Disease Research at AD/PD 2025
• UCB presented 8 scientific abstracts at AD/PD 2025, including subgroup analysis of bepranemab's TOGETHER trial for Alzheimer's disease, the first anti-tau therapy showing clinical efficacy.
• The company's Parkinson's disease research program features UCB7853, an anti-alpha-synuclein antibody, and glovadalen (UCB0022), an oral D1 receptor positive allosteric modulator designed for improved symptom control.
• Despite ORCHESTRA trial for minzasolmin not meeting clinical endpoints in early-stage Parkinson's disease, UCB continues advancing multiple therapeutic approaches targeting underlying disease mechanisms and symptom management.
FDA Expands Evrysdi Approval to Include Infants Under Two Months with Spinal Muscular Atrophy
• Roche and PTC Therapeutics' oral SMA drug Evrysdi (risdiplam) receives FDA approval for use in infants younger than two months, enabling treatment across all age groups from newborns to adults.
• The RAINBOWFISH study demonstrated significant efficacy, with treated pre-symptomatic babies achieving key developmental milestones including sitting, standing, and walking within 12 months.
• The expanded approval positions Evrysdi to compete directly with Biogen's Spinraza and Novartis' Zolgensma, while offering the advantage of at-home oral administration.
UCB's Bepranemab Shows Promise in Reducing Tau Tangles in Alzheimer's Subgroup
• Bepranemab, a monoclonal antibody from UCB Pharma, is the first to demonstrate a slowing of tau tangle accumulation in Alzheimer's patients, marking a potential shift in treatment strategies.
• Phase 2 trial data suggests cognitive benefits in a subgroup with low baseline tau levels and without the ApoE4 mutation, indicating a targeted approach may be necessary for efficacy.
• The trial results support the hypothesis that extracellular tau 'seeds' drive Alzheimer's progression, opening avenues for understanding disease mechanisms and developing combination therapies.
• Several companies are developing antibodies targeting the microtubule binding region (MTBR) of tau, with ongoing trials exploring their impact on tau spread and clinical outcomes.
Bepranemab Shows Promise in Slowing Tau Accumulation in Alzheimer's Disease
• Phase 2a trial (TOGETHER) of bepranemab in prodromal to mild Alzheimer's showed no significant benefit in the primary endpoint, CDR-SB total score.
• Bepranemab demonstrated significant improvement in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score at week 80.
• The study suggests bepranemab, an anti-tau antibody targeting the mid-region of tau, may slow tau accumulation, with potential cognitive benefits.
• Further studies in larger, more diverse populations are needed to confirm these findings and explore patient subgroups with greater sensitivity.
Iron Chelator Deferiprone Shows Adverse Effects in Early Alzheimer's Disease Trial
• A JAMA Neurology study reveals that deferiprone, while successfully reducing brain iron accumulation, unexpectedly accelerated cognitive decline in early Alzheimer's disease patients.
• Multiple experimental Alzheimer's treatments show mixed results, with UCB's bepranemab missing its primary cognitive endpoint while Lexeo's gene therapy LX1001 demonstrates promising biomarker improvements.
• Out-of-pocket costs for neurological disease medications have risen significantly over the past decade, with multiple sclerosis drug costs increasing by an average of 217% from 2012 to 2021.
UCB Evaluates Future of Bepranemab After Phase II Trial Fails to Meet Endpoints Amidst Roche Partnership Exit
• UCB is reassessing the future of its anti-tau antibody, bepranemab, following disappointing Phase II trial results in Alzheimer's disease.
• The Phase II trial suggests potential benefits in specific patient subgroups, but overall, the drug did not meet its primary endpoints.
• Roche's decision to exit the partnership further complicates the development path for bepranemab, increasing uncertainty for UCB.
• UCB is now considering strategic options for bepranemab, weighing the potential for further development against the challenges of advancing the drug alone.
Regeneron Faces Eylea Uncertainty; Madrigal's Rezdiffra Exceeds Expectations
• Regeneron's shares declined due to concerns over Eylea sales, despite hopes for new drugs targeting blood clots, lung cancer, and obesity to revitalize growth.
• Madrigal Pharmaceuticals' Rezdiffra, a MASH treatment, significantly surpassed sales forecasts, with $62 million in sales reported for the third quarter.
• UCB's bepranemab, an Alzheimer's drug, showed promising signs of slowing cognitive decline in a mid-stage trial, despite missing its primary endpoint.
• AbbVie is collaborating with EvolveImmune Therapeutics to develop multispecific antibody drugs for cancer, providing $65 million upfront with potential for $1.4 billion more.
Madrigal's MASH Drug Rezdiffra Sees Strong Launch, Compass Pathways Lays Off Staff
• Madrigal Pharmaceuticals reported $62 million in third-quarter sales for Rezdiffra, its MASH treatment, exceeding expectations and tripling the number of patients on the drug.
• Compass Pathways is laying off 30% of its staff due to longer-than-expected clinical trial timelines for its psilocybin treatment COMP360 for treatment-resistant depression.
• A Phase 2 trial of UCB's tau-targeting antibody bepranemab in Alzheimer's disease slowed tau accumulation but failed to meet its primary endpoint of slowing disease progression.
Bepranemab Shows Promise in Slowing Tau Accumulation and Cognitive Decline in Early Alzheimer's
• Phase 2a trial of bepranemab in early Alzheimer's shows slowed tau accumulation in key brain regions by 33-58% compared to placebo.
• Cognitive decline, measured by ADAS-Cog14, was reduced by 21-25% with bepranemab treatment versus placebo at Week 80.
• Subgroup analysis reveals greater benefits in patients with low baseline tau and APOε4 non-carriers, with up to 67% reduction in tau accumulation.
• Bepranemab demonstrated an acceptable safety profile, with brain haemorrhagic and inflammatory changes similar to placebo.
Bepranemab Shows Promise in Slowing Tau Accumulation and Cognitive Decline in Early Alzheimer's
• Bepranemab, an anti-tau antibody, slowed tau accumulation in key brain regions by 33-58% in a Phase 2a trial for early Alzheimer's disease.
• Cognitive decline was reduced by 21-25% with bepranemab treatment compared to placebo, as measured by the ADAS-Cog14 scale.
• Subgroup analysis revealed greater benefits in patients with low baseline tau levels and APOE4 non-carriers, with up to 67% reduction in tau accumulation.
• The drug demonstrated an acceptable safety profile, with brain haemorrhagic and inflammatory changes similar to placebo.
Roche Terminates Alzheimer's Partnership with UCB, Returns Rights to Bepranemab
• Roche has ended its collaboration with UCB, relinquishing rights to bepranemab, a Phase 2a Alzheimer's candidate, marking the second Alzheimer's partnership termination this year.
• The initial agreement in July 2020 involved a $120 million upfront payment and potential milestone payments up to $2 billion for bepranemab development.
• UCB will proceed with the Phase 2a trial of bepranemab, presenting the results at the Alzheimer's Clinical Trials Conference 2024 in Spain.
• Roche's exit follows the failure of gantenerumab in 2022, but the company continues to focus on early Alzheimer's diagnosis and other early-stage assets like trontinemab.
UCB's Bepranemab Shows Promise in Phase 2a Alzheimer's Disease Trial
• UCB's bepranemab, an anti-tau antibody, demonstrated encouraging results in a Phase 2a study for prodromal to mild Alzheimer's disease, warranting further investigation.
• The TOGETHER study evaluated the efficacy, safety, and tolerability of bepranemab versus placebo over an 80-week treatment period, followed by an open-label extension.
• Bepranemab targets a central region of tau protein, aiming to interfere with the cell-to-cell propagation of pathogenic, aggregated tau in Alzheimer's disease.
• UCB has regained all global rights to bepranemab after terminating its collaboration agreement with Genentech and Roche, paving the way for further independent development.
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