BHV-8000 / Biohaven, Highlightll Pharma - LARVOL DELTA

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease (clinicaltrials.gov) - P2/3 | N=550 | Recruiting | Sponsor: Biohaven Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

Biohaven Enrolls First Patient into Phase 2/3 Trial in Early Parkinson's Disease, Targeting Neuroinflammation with Novel Brain-Penetrant TYK2/JAK1 Inhibitor (PRNewswire) - "Biohaven Ltd...announced today that it has initiated a global Phase 2/3 study of the first-in-clinic, orally-administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, BHV-8000, for the treatment of early Parkinson's disease (PD)."

Trial status • Parkinson's Disease

Biohaven Reports First Quarter 2025 Financial Results and Recent Business Developments (PRNewswire) - "Expected Upcoming Milestones:...TYK2/JAK1 Inhibitor (BHV-8000): (i) Initiate BHV-8000 Phase 2/3 study in Parkinson's disease in 1H 2025; (ii) Advance Alzheimer's disease, multiple sclerosis ('MS') and amyloid-related imaging abnormalities ('ARIA') programs."

New P2/3 trial • Pipeline update • Alzheimer's Disease • Multiple Sclerosis • Parkinson's Disease

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease (clinicaltrials.gov) - P2/3 | N=550 | Not yet recruiting | Sponsor: Biohaven Therapeutics Ltd.

New P2/3 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

BHV-8000, a Selective Brain-Penetrant TYK2/JAK1 Inhibitor in Development for Neuroinflammatory and Neurodegenerative Diseases, Demonstrates Favorable PK/PD and Safety Profile in Phase 1 Studies (P9-2.010). (PubMed, Neurology) - "Qureshi has stock in Biohaven Pharmaceuticals. Author has nothing to disclose."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Inflammation • Pain • CRP • JAK2 • TYK2

BHV-8000, a Selective Brain-penetrant TYK2/JAK1 Inhibitor in Development for Neuroinflammatory and Neurodegenerative Diseases, Demonstrates Efficacy in an Alpha-Synuclein Overexpressing Parkinson's Disease Mouse Model (S4.006). (PubMed, Neurology) - "Lair has a non-compensated relationship as a Board Member with NY State Neurological Society that is relevant to AAN interests or activities. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

Journal • Preclinical • CNS Disorders • Inflammation • Movement Disorders • Parkinson's Disease • AIF1 • IL6 • JAK2 • TYK2

Biohaven Presents Data Across Innovative Neuroscience Portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting (PRNewswire) - "Biohaven Ltd....announced today that it will present 13 abstracts at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025 in San Diego, California. The presentations highlight Biohaven's innovative neuroscience pipeline across multiple early and late-stage development programs including Kv7 ion channel modulation, extracellular protein degradation, TRPM3 antagonism, TYK2/JAK1 inhibition, and glutamate modulation."

Clinical data • Migraine • Parkinson's Disease

BHV-8000, A SELECTIVE BRAIN -PENETRANT TYK2/JAK1 INHIBITOR FOR NEUROINFLAMMATORY AND NEURODEGENERATIVE DISEASES, DEMONSTRATES FAVORABLE PK/PD AND SAFETY IN PHASE 1 STUDIES (ADPD 2025) - "Phase 1 data demonstrate BHV -8000 is a brain -penetrant oral small molecule with a favorable safety profile and the potential to provide disease -modifying effects in neuroinflammatory and neurodegenerative conditions including AD and PD."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Inflammation • Movement Disorders • Pain • Parkinson's Disease • CRP • JAK1 • JAK2 • JAK3 • TYK2

Biohaven Reports Recent Business Developments and Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "Glutamate Modulator (Troriluzole)...Topline data from two Phase 3 OCD trials in 1H 2025 and 2H 2025, respectively. Myostatin (Taldefgrobep alfa): Expect FDA meeting to discuss SMA registrational path in 1H 2025. Initiate taldefgrobep Phase 2 study in obesity in 1H 2025. Continue advancing enrollment in proof of concept trial with BHV-2100 in acute migraine; data from the laser-evoked potential study expected in 1H 2025...Initiate BHV-8000 Phase 2/3 study in Parkinson's disease in 1H 2025."

FDA event • New P2 trial • New P2/3 trial • P2 data • P3 data • Migraine • Muscular Atrophy • Obesity • Obsessive-Compulsive Disorder • Parkinson's Disease

BHV-8000, a Selective Brain-Penetrant TYK2/JAK1 Inhibitor in Development for Neuroinflammatory and Neurodegenerative Diseases, Demonstrates Favorable PK/PD and Safety Profile in Phase 1 Studies (AAN 2025) - "In healthy adults, BHV-8000 was generally safe and well-tolerated, while demonstrating anti-inflammatory effects and a favorable PK profile in the periphery and CNS. These results support continued development of BHV-8000 for neurodegenerative conditions, including PD, MS, AD, and ARIA."

Clinical • P1 data • PK/PD data • CNS Disorders • Inflammation • Pain • CRP • JAK2 • TYK2

BHV-8000, a Selective Brain-penetrant TYK2/JAK1 Inhibitor in Development for Neuroinflammatory and Neurodegenerative Diseases, Demonstrates Efficacy in an Alpha-Synuclein Overexpressing Parkinson's Disease Mouse Model (AAN 2025) - "BHV-8000 administration reduced abnormal locomotor behavior deficits, inhibited inflammatory microglial activation, and protected against neurodegeneration in α-Syn overexpressing mice. These results support the potential of JAK1/TYK2 inhibition with BHV-8000 as a novel, disease modifying approach to the treatment of PD and other neuroinflammatory and neurodegenerative diseases."

Preclinical • CNS Disorders • Inflammation • Movement Disorders • Parkinson's Disease • AIF1 • IL6 • JAK2 • TYK2

BHV-8000, a Selective Brain-Penetrant TYK2/JAK1 Inhibitor in Development for Neuroinflammatory and Neurodegenerative Diseases, Demonstrates Favorable PK/PD and Safety Profile in Phase 1 Studies (CTAD 2024) - No abstract available

Clinical • Late-breaking abstract • P1 data • PK/PD data • CNS Disorders • TYK2

Therapeutic Effects of a Selective Brain-Penetrant TYK2 JAK1 Inhibitor in an A-Syn Overexpressing Mouse Model of Parkinson's Disease (ANA 2024) - "TLL041 treatment reduced PD-related motor behavior, inhibited the neuroinflammation response and protected neurons against degeneration in α-Syn over-expressing PD mice. These results warrant further research into the therapeutic benefits of TLL041 for the treatment of PD."

Late-breaking abstract • Preclinical • CNS Disorders • Parkinson's Disease • TYK2

Biohaven Reports First Quarter 2024 Financial Results and Recent Business Developments (PRNewswire) - "BHV-8000, our TYK2/JAK1 inhibitor, paving the way for multiple clinical trial initiations in 2024, such as Parkinson's disease, Alzheimer's disease and prevention of Amyloid-Related Imaging Abnormalities (ARIA) associated with amyloid lowering agents....Initiate BHV-2100 Phase 2 study in acute migraine in 2H 2024..."

New P2 trial • Alzheimer's Disease • CNS Disorders • Migraine • Pain • Parkinson's Disease

Biohaven Highlights Progress Across Innovative Portfolio and Outlines 2024 Anticipated Milestones at the 42nd Annual J.P. Morgan Healthcare Conference; Established Extensive Portfolio Across 20 Therapeutic Indications in Neuroscience, Immunology and Oncology (PRNewswire) - "Anticipated 2024 Clinical Milestones:...(i) Initiate BHV-8000 Phase 2 study in Multiple Sclerosis in 2Q 2024; (ii) Initiate BHV-8000 Phase 2a study in prevention of amyloid therapy induced ARIA in 2H 2024; (iii) Initiate BHV-8000 Phase 2/3 study in early Parkinson's disease in 2H 2024; (iv) Initiate BHV-8000 Phase 2/3 study in early Alzheimer's disease in 2H 2024."

New P2 trial • New P2/3 trial • New P2a trial • Alzheimer's Disease • Multiple Sclerosis • Parkinson's Disease

Biohaven Reports Third Quarter 2023 Financial Results and Recent Business Developments (PRNewswire) - "Initiate Phase 2/3 study with brain penetrant, dual TYK2/JAK1 inhibitor BHV-8000 in Parkinson's disease: The Company commenced Phase 1 studies with BHV-8000, an oral, brain-penetrant, dual TYK2/JAK1 inhibitor for neuroinflammatory disorders, in the first half of 2023 and expects to initiate a Phase 2/3 study in Parkinson's disease in 2024."

New P2/3 trial • Trial status • CNS Disorders • Immunology • Parkinson's Disease

Biohaven Provides Preliminary EEG Data Update for Kv7 Platform, Regulatory Update on Troriluzole and Other Corporate Updates (PRNewswire) - P1 | N=NA | "Biohaven has now successfully dosed three dose cohorts with single ascending doses of its brain penetrant TYK2/JAK1 agent, BHV-8000, in the ongoing Phase 1 study....Based on the preliminary data that are available, projected therapeutic concentrations of BHV-8000 were achieved, and BHV-8000 was well tolerated with only mild adverse events reported. These data support further development of BHV-8000, and Biohaven anticipates beginning a Phase 2 clinical trial with BHV-8000 in Parkinson's disease and potentially other neuroinflammatory diseases in 2024."

New P2 trial • P1 data • Trial status • CNS Disorders • Parkinson's Disease

Biohaven Provides Overview of Clinical Progress, Regulatory Updates, and Pipeline Developments at R&D Day (Yahoo News) - "TYK2/JAK1 Inhibition in Immune-Mediated Brain Disorders: Began dosing with BHV-8000 (an oral, brain-penetrant, dual TYK2/JAK1 inhibitor) in a ­­­Phase 1 study in normal healthy volunteers."

Trial status • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology • Multiple Sclerosis • Parkinson's Disease • Proteinopathy • Tauopathies And Synucleinopathies

Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders (PRNewswire) - “Biohaven Ltd…announced that it acquired global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders. BHV-8000 (previously TLL-041) was licensed from Hangzhou Highlightll Pharmaceutical Co. Ltd. (Highlightll) and Biohaven anticipates advancing the agent into a Phase 1 study in 2023….BHV-8000 (previously TLL-041) is a highly selective, brain-penetrant, dual TYK2/JAK1 inhibitor. TYK2 and JAK1 are STAT pathway activators addressing a range of proinflammatory cytokines; inhibition of these kinases may play a significant role in reducing inflammation in neurological disorders including Parkinson's Disease, Alzheimer's Disease, Amyotrophic Lateral Sclerosis, and Multiple Sclerosis.”

Licensing / partnership • New P1 trial • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Multiple Sclerosis • Parkinson's Disease