H. Lundbeck A/S

Lundbeck Partners with DCAI to Accelerate Brain Disorder Drug Discovery Using Gefion AI Supercomputer

16 days ago

• Lundbeck has partnered with the Danish Centre for AI Innovation to utilize Denmark's flagship Gefion AI supercomputer for accelerating neurological and psychiatric drug discovery. • The collaboration aims to address significant unmet needs in brain health, with brain disorders affecting approximately half of the global population and many patients having limited treatment options. • Gefion's computational power will enable AI-driven insights for molecule discovery and drug optimization, potentially identifying novel treatments for known targets and unlocking emerging drug targets for rare neurological conditions.

Lundbeck Expands PROCEED Trial to Include Intravenous Administration of Novel Anti-PACAP Antibody for Migraine Prevention

2 months ago

• Following a planned interim analysis of the Phase IIb PROCEED trial, Lundbeck will expand testing of Lu AG09222, a first-in-class anti-PACAP monoclonal antibody, to include intravenous administration for migraine prevention. • The trial targets patients with migraine who have failed 1-4 previous preventive treatments, addressing a significant unmet need affecting an estimated 2.5-3.0 million patients in G7 countries. • The PROCEED trial is expected to complete in the first half of 2026, with pivotal Phase III trials planned to begin in the second half of 2026, potentially offering a new treatment pathway distinct from CGRP-targeting therapies.

Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval

2 months ago

• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries. • Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages. • Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.

European Commission Approves Rxulti for Adolescent Schizophrenia Treatment

2 months ago

• The European Commission has approved Rxulti (brexpiprazole) for treating schizophrenia in adolescents aged 13 years and older, expanding its previous 2018 approval for adults. • Approval was based on a 6-week clinical trial of 316 adolescents showing significant symptom reduction as measured by PANSS scores, with a safety profile consistent with adult patients. • Adolescent-onset schizophrenia often has poorer prognosis than adult-onset, with more chronic and severe symptoms, making this new treatment option particularly significant for young European patients.

Global Neuroregeneration Therapy Market Set to Reach $64.8 Billion by 2034, Driven by AI and Stem Cell Innovations

3 months ago

• The neuroregeneration therapy market is projected to grow at a 5.3% CAGR from 2024 to 2034, with North America leading the expansion due to advanced healthcare infrastructure and strong research funding. • Recent breakthroughs include Biogen's promising gene therapy trials for Parkinson's disease and BrainStorm Cell Therapeutics' regulatory approval for stem cell-based ALS treatment. • Artificial intelligence, stem cell research, and gene therapy applications are reshaping the therapeutic landscape, with major pharmaceutical companies forming strategic partnerships to accelerate innovation.

FDA to Review Rexulti for PTSD Treatment Amidst PDUFA Delay

5 months ago

• The FDA will convene a Psychopharmacologic Drugs Advisory Committee (PDAC) to review Rexulti (brexpiprazole) in combination with sertraline for treating PTSD in adults. • The FDA's decision to host a PDAC meeting indicates a delay in the Prescription Drug User Fee Act (PDUFA) target action date, originally set for February 8, 2025. • Clinical trial data supports the combination of brexpiprazole and sertraline, showing statistically significant improvements in PTSD symptoms compared to sertraline alone. • Rexulti, developed by Otsuka and Lundbeck, is already approved for major depressive disorder, schizophrenia, and agitation associated with Alzheimer's disease.

Vyepti Demonstrates Efficacy in Patients with Chronic Migraine and Medication-Overuse Headache

6 months ago

• The RESOLUTION trial demonstrated that Vyepti (eptinezumab) is effective for patients with chronic migraine and medication-overuse headache (MOH). • Patients treated with Vyepti experienced statistically significant reductions in monthly migraine days (MMD) compared to placebo over weeks 1-4. • A significantly greater proportion of patients treated with Vyepti no longer met the diagnostic criteria for chronic migraine or MOH after treatment. • The trial confirmed the early onset of Vyepti’s efficacy, with significant reductions in pain severity and acute medication use.

Amlenetug Receives FDA Fast Track Designation for Multiple System Atrophy

6 months ago

• The FDA has granted Fast Track Designation to Lundbeck's amlenetug for the potential treatment of Multiple System Atrophy (MSA). • The designation is supported by Phase II AMULET trial outcomes and will expedite the drug development process through rolling reviews and intensive guidance. • Amlenetug, a human monoclonal antibody, targets extracellular α-synuclein to prevent uptake and aggregation, potentially slowing MSA progression. • Lundbeck has initiated the Phase III MASCOT trial to evaluate the efficacy, safety, and tolerability of amlenetug in MSA patients across North America, Europe, and Asia.

Bexicaserin Shows Sustained Seizure Reduction in Developmental Epileptic Encephalopathies

6 months ago

• Bexicaserin demonstrated a 59.3% median reduction in countable motor seizures over 12 months in patients with developmental and epileptic encephalopathies (DEEs). • The PACIFIC open-label extension study showed consistent seizure reduction in both patients who switched from placebo to bexicaserin and those who continued treatment. • Longboard Pharmaceuticals, now acquired by Lundbeck, is advancing bexicaserin into Phase 3 trials, including the DEEp SEA study for Dravet syndrome. • Bexicaserin's favorable safety profile and tolerability were maintained throughout the 12-month extension, supporting its potential as a treatment for DEEs.

Longboard Pharmaceuticals Advances Bexicaserin for Dravet Syndrome

6 months ago

• Longboard Pharmaceuticals initiated a Phase 3 clinical trial, DEEp SEA, to evaluate bexicaserin in Dravet syndrome patients aged 2-65 years. • Bexicaserin received Orphan Drug and Rare Pediatric Disease designations from the FDA for treating Dravet syndrome, highlighting its potential impact. • The EMA's Paediatric Committee issued a positive opinion on the Paediatric Investigation Plan for bexicaserin in children as young as two years old. • Lundbeck A/S is set to acquire Longboard, marking a strategic move to further develop novel neurological disease treatments.

Longboard Pharmaceuticals Initiates Phase 3 Trial of Bexicaserin for Dravet Syndrome

6 months ago

• Longboard Pharmaceuticals has started a Phase 3 clinical trial, DEEp SEA, to assess bexicaserin in Dravet syndrome patients aged 2-65 years. • Bexicaserin, a selective 5-HT2C receptor superagonist, continues to show sustained seizure reduction and a favorable safety profile in DEEs. • The FDA granted Orphan Drug and Rare Pediatric Disease designations to bexicaserin for treating Dravet syndrome, highlighting its potential impact. • H. Lundbeck A/S is set to acquire Longboard, a strategic move following positive developments in bexicaserin's clinical program.

Vyepti (Eptinezumab) Shows Positive Phase III Results in Asian Migraine Patients

7 months ago

• Vyepti (eptinezumab) met the primary endpoint in the SUNRISE trial, demonstrating statistically significant reductions in monthly migraine days (MMD) compared to placebo. • Patients treated with Vyepti (100mg and 300mg) experienced mean reductions of 7.2 and 7.5 MMDs, respectively, compared to 4.8 days for placebo over weeks 1-12. • A significantly greater proportion of patients achieved at least a 50% reduction in monthly migraine days with Vyepti compared to placebo. • The safety profile of Vyepti in the SUNRISE trial was consistent with previous trials, with the most common adverse events being COVID-19 and nasopharyngitis.

Vyepti (Eptinezumab) Demonstrates Efficacy in Phase III SUNRISE Trial for Migraine Prevention

7 months ago

• Lundbeck's Vyepti (eptinezumab) met the primary endpoint in the Phase III SUNRISE trial, significantly reducing monthly migraine days compared to placebo. • The SUNRISE trial confirmed Vyepti's efficacy in chronic migraine patients in Asia, with statistically significant reductions observed from day 1 post-infusion. • Vyepti demonstrated a favorable safety profile in the SUNRISE trial, consistent with previous studies, supporting its potential as a preventive migraine treatment. • Lundbeck plans to engage with regulatory authorities to potentially make Vyepti available for migraine sufferers across Asia based on the positive trial results.

Vyepti (Eptinezumab) Shows Positive Phase III Results in Asian Migraine Patients

7 months ago

• Lundbeck's Vyepti (eptinezumab) met the primary endpoint in the SUNRISE Phase III trial, demonstrating statistically significant reductions in monthly migraine days compared to placebo. • The SUNRISE trial confirmed Vyepti's efficacy across all key secondary endpoints, with the treatment generally well-tolerated among chronic migraine patients in Asia. • Vyepti led to statistically significant reductions in the risk of experiencing migraine starting from day 1 post-infusion, compared to placebo, highlighting its rapid onset of action. • Lundbeck plans to engage with regulatory authorities to potentially make Vyepti available for migraine sufferers across Asia, addressing a significant unmet need.

Epilepsy Pipeline Shows Promise with Novel Therapies in Clinical Trials

7 months ago

• Over 90 epilepsy treatment therapies are under development by more than 75 companies globally, targeting various mechanisms of action and routes of administration. • Longboard Pharmaceuticals reported positive Phase Ib/IIa results for LP352 (bexicaserin) in developmental and epileptic encephalopathies (DEEs), showing a significant reduction in seizure frequency. • Amzell has initiated a study comparing AMZ002 with Vigabatrin for treating infantile spasms, a rare and severe form of epilepsy, to assess efficacy and safety. • Emerging therapies like RLS103, CT-010, Darigabat, and XEN496 are in different clinical trial phases, indicating potential advancements in epilepsy management.

Otsuka's Sibeprenlimab Shows Positive Phase 3 Interim Results for IgA Nephropathy

7 months ago

• Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo. • The Phase 3 VISIONARY trial met its primary endpoint after nine months of treatment in adults with IgA nephropathy. • Otsuka plans to discuss the interim results with the FDA, potentially leading to an accelerated regulatory submission for sibeprenlimab. • Sibeprenlimab targets APRIL, a key factor in the immune pathogenic cascade of IgA nephropathy, offering a potential new therapeutic strategy.

Relacorilant and Surgery Improve Hemostatic Markers in Cushing's Syndrome

8 months ago

• A study shows that hypercoagulopathy, a complication in Cushing's Syndrome (CS), improves with both relacorilant treatment and surgery. • Relacorilant, a selective glucocorticoid receptor modulator (SGRM), demonstrated improvements in coagulation markers after 3-4 months of treatment. • Surgical intervention also led to improvements in coagulation markers within an average of 6 months post-operation in CS patients. • The study suggests relacorilant may offer a beneficial treatment option for CS patients, particularly those at high risk of VTE or not suitable for surgery.