BHV-2100 / University of Leuven, Biohaven - LARVOL DELTA

Biohaven Reports First Quarter 2025 Financial Results and Recent Business Developments (PRNewswire) - "Expected Upcoming Milestones:...(i) Myostatin (Taldefgrobep alfa): FDA interaction to discuss Spinal Muscular Atrophy ('SMA') registrational path planned in 1H 2025. Initiate taldefgrobep Phase 2 study in obesity in 1H 2025; (ii) TRPM3 Antagonist (BHV-2100): Expect data from proof-of-concept trial with BHV-2100 in acute migraine in 1H 2025."

FDA event • New P2 trial • P2 data • Migraine • Muscular Atrophy • Obesity • Pain

BHV-2100, a First-in-Class TRPM3 Antagonist in Development for the Treatment of Migraine (P7-12.009). (PubMed, Neurology) - P2 | "Dr. Lipton has received publishing royalties from a publication relating to health care."

Clinical • Journal • CNS Disorders • Migraine • Pain • TRPM3

Safety, Tolerability, and Pharmacokinetics of BHV-2100, a First-in-class TRPM3 Antagonist for Pain and Migraine (S11.004). (PubMed, Neurology) - P2 | "SAD participants were randomized 3:1 to single dose BHV-2100 (25, 75, 150, 250, or 500mg) or placebo under fasting conditions; 150mg was also tested with food and famotidine. Vladimir Coric has stock in Biohaven. Vladimir Coric has received intellectual property interests from a discovery or technology relating to health care."

Clinical • Journal • PK/PD data • CNS Disorders • Fatigue • Migraine • Pain • TRPM3

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

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-2100, a First-in-Class TRPM3 Antagonist in Development for the Treatment of Migraine (AAN 2025) - P2 | "TRPM3 is a novel target for the treatment of migraine and pain. BHV-2100 is a first-in-class TRPM3 antagonist being studied for acute treatment of migraine with the potential to address the needs of millions of patients who continue to seek better migraine relief."

CNS Disorders • Migraine • Pain • TRPM3

BHV-2100, a First-in-Class TRPM3 Antagonist in Development for the Treatment of Migraine (AAN 2025) - No abstract available

CNS Disorders • Migraine • Pain • TRPM3

Safety, Tolerability, and Pharmacokinetics of BHV-2100, a First-in-class TRPM3 Antagonist for Pain and Migraine (AAN 2025) - P2 | "TRPM3 represents a novel target for the treatment of pain and migraine. BHV-2100 demonstrated excellent safety and pharmacokinetics and is being evaluated in clinical trials for pain (EudraCT 2024-512187-57) and migraine (NCT06603623) as a novel non-opioid treatment."

Clinical • PK/PD data • CNS Disorders • Fatigue • Migraine • Pain • TRPM3

Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine (clinicaltrials.gov) - P2 | N=575 | Active, not recruiting | Sponsor: Biohaven Therapeutics Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine • Pain

Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine (clinicaltrials.gov) - P2 | N=575 | Recruiting | Sponsor: Biohaven Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine (clinicaltrials.gov) - P2 | N=575 | Not yet recruiting | Sponsor: Biohaven Therapeutics Ltd.

New P2 trial • CNS Disorders • Migraine • Pain

Safety, Tolerability, and Pharmacokinetics of BHV-2100, a First-in-Class TRPM3 Antagonist for Pain (IASP 2024) - "In the SAD cohorts, participants were randomized 3:1 to a single dose of BHV-2100 (25, 75, 150, 250, or 500 mg) or placebo under fasting conditions; the 150 mg dose was also tested for effects of food and an antiacid agent (famotidine). TRPM3 represents a novel target for the treatment of pain and migraine. BHV-2100 is a potent, selective, orally administered, first-in-class TRPM3 antagonist that was safe and well tolerated at single doses up to 500 mg in this first-in-human study. BHV-2100 did not cause thermoregulatory side effects observed with other TRP antagonists or sedation and gastrointestinal side effects associated with standard-of-care pain medications."

Clinical • PK/PD data • Anesthesia • CNS Disorders • Gastrointestinal Disorder • Immunology • Migraine • Pain • TRPM3

BHV-2100, A First-In-Class TRPM3 Antagonist for the Treatment of Neuropathic Pain (IASP 2024) - "BHV-2100 is a potent, selective, peripherally restricted, orally administered, first-in-class TRPM3 antagonist that reverses pain in a spectrum of animal models without causing the sedative effects that severely limit current standard of care treatments for pain. Importantly, in preclinical models, BHV-2100 does not cause the adverse thermoregulatory effects that have prohibited the pharmacological targeting of other TRP family ion channels. These findings provide a compelling rationale for the advancement of BHV-2100 into currently ongoing human clinical trials as a potentially novel, highly effective, and non-sedating non-opioid treatment for pain."

Addiction (Opioid and Alcohol) • Diabetic Neuropathy • Immunology • Neuralgia • Pain • Peripheral Neuropathic Pain • TRPA1 • TRPM3 • TRPM8 • TRPV1

First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of the First-in-Class TRPM3 Antagonist BHV-2100 in Development for Migraine and Pain (AHS 2024) - No abstract available

Clinical • P1 data • PK/PD data • CNS Disorders • Migraine • Pain • TRPM3

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

BHV-2100, a First-in-class TRPM3 Antagonist for the Treatment of Pain (AAN 2024) - "BHV-2100 is a potent and selective TRPM3 antagonist that reduces pain in preclinical models without thermoregulatory or sedative effects. These findings support the advancement of BHV-2100 to human trials as a novel potential treatment for pain."

Diabetic Neuropathy • Neuralgia • Pain • TRPM3

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-2100 Phase 2 study in acute migraine in 2H 2024; (ii) Conduct BHV-2100 POC study for neuropathic pain in 2H 2024."

New P2 trial • New trial • Migraine • Pain