BHV-1300 / Biohaven - LARVOL DELTA

Evaluating Single and Multiple Doses of an Optimized Subcutaneous Formulation of BHV-1300 in a Phase 1, Randomized, Open-Label, Placebo-Controlled Study (ANZCTR) - P1 | N=64 | Recruiting | Sponsor: Biohaven Therapeutics Limited | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2024

Enrollment open • Trial initiation date • Immunology

Biohaven Reports Recent Business Developments and Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "IgG MoDE Degraders (1300/1310): BHV-1300 Phase 1 with the optimized subcutaneous formulation completing in 1H 2025. BHV-1310 completion of preclinical testing prior to anticipated FIH study initiating 1H 2025...Phase 1 with BHV-1400 and BHV-1600 expected to be completed in 1H 2025...Kv7 Activator (BHV-7000): Pivotal major depressive disorder topline results expected in 2H 2025. Focal epilepsy study topline results expected in 1H 2026."

Clinical data • Preclinical • Trial completion date • Epilepsy • IgA Nephropathy • Immunology • Major Depressive Disorder

Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300 (PRNewswire) - P1 | N=8 | ACTRN12624001129572 | Sponsor: Biohaven Therapeutics Limited | "Up to 84% reduction of total IgG was observed with a median reduction of 80% after subcutaneous weekly 1000 mg dosing in the ongoing Phase 1 study. Subcutaneous BHV-1300 achieved progressive reductions in IgG levels within hours of each weekly dose administration, and pharmacodynamic effects were sustained compared to baseline over the four-week period...BHV-1300 has been safe and well tolerated across the ongoing Phase 1 studies with subcutaneous doses now administered up to 2000 mg. Most adverse events (AEs) were mild and self-resolving, there were no discontinuations due to AEs related to study drug, and there were no serious or severe AEs...Biohaven reiterates its plans to initiate a Phase 2 study in Graves' disease in mid-2025."

New P2 trial • P1 data • Grave’s Disease • Immunology

Molecular Degraders of Extracellular Protein (MoDEsTM) Rapidly and Effectively Remove Interstitial IgG and Disease-Relevant Immune Complexes Through Endo-lysosomal Degradation in the Liver (ACR Convergence 2024) - "In these in vitro and in vivo studies, extracellular IgG degraders (BHV-1300/-1310) from the MoDE drug platform demonstrated the ability to remove interstitial IgG and disease-relevant immune complexes through endo-lysosomal degradation in the liver. This new modality offers an attractive and differentiated therapeutic strategy for treating a spectrum of autoimmune conditions by targeting pathogenic autoantibodies and immune complexes that play a critical role in disease onset, progression and end organ damage."

CNS Disorders • Immunology • Inflammatory Arthritis • Myasthenia Gravis • Rheumatoid Arthritis • Rheumatology • MUC4

Novel IgG Degrader BHV-1300 Demonstrates the Ability to Remove Anti-bDMARD ADA and Allows for Co-administration with Fc-containing Biologics (ACR Convergence 2024) - "These data demonstrate BHV-1300 does not adversely affect exposure to adalimumab and that it can reduce neutralizing ADAs. MoDE IgG degraders can be co-administered with bDMARDs in RA. Thus, MoDE degraders offer a unique combinatorial therapeutic approach for difficult to treat RA and other rheumatologic diseases, enabling removal of ADAs, pathogenic autoantibodies, and immune complexes as key differentiated features compared to other approaches."

Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • ASGR • MUC4

Evaluating Multiple Doses of an Optimized Subcutaneous Formulation of BHV-1300 in a Phase 1, Randomized, Open-Label, Placebo-Controlled Study (ANZCTR) - P1 | N=8 | Not yet recruiting | Sponsor: Biohaven Therapeutics Limited

New P1 trial • Immunology

PHARMACOKINETICS OF ADALIMUMAB IN CYNOMOLGUS MONKEYS FOLLOWING DOSING WITH BHV-1300, A FIRST-IN-CLASS MOLECULAR DEGRADER OF IgG (EULAR 2024) - "These data demonstrate that BHV-1300 does not adversely affect exposure to adalimumab and provide supporting evidence that MoDE IgG degraders such as BHV-1300 can be effectively used in combination with biological DMARDs in the management of difficult-to-treat autoimmune diseases. These results represent a key differentiating feature from neonatal Fc receptor inhibitors, which adversely affect the exposure to and effectiveness of, and cannot be co-administered with, Fc-containing biologics, including adalimumab. Moreover, BHV-1300 potentially offers a significantly improved benefit-risk based on other important mechanistic advantages including rapid onset of IgG-lowering, shortened time to maximal effect, depth of IgG lowering, brief period of exposure, potential for reduced immunosuppression, and lack of effects on albumin, cholesterol or triglycerides."

PK/PD data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • ASGR

Novel Bispecific Degrader BHV-1300 Achieves Rapid, Robust, and Selective IgG Reduction in Preclinical Models Including Nonhuman Primates (AAN 2024) - "BHV-1300 demonstrated rapid, robust, safe, and selective IgG reductions in monkeys and rabbits. This compares favorably to published data for FcRn inhibitor IgG reducing therapies; BHV-1300 has important differentiating properties: speed of onset, shortened time to maximal effect, depth of IgG lowering, ability to be co-administered with biologics and target-related safety. Coupled with other potential mechanistic advantages (brief period of exposure; lack of effects on albumin, cholesterol, or triglycerides; potential for reduced immunosuppression; and compatibility with Fc-containing biologics), BHV-1300 represents the first member of a new drug class with potentially significantly improved benefit-risk for neuroinflammatory and autoimmune disorders including acute manifestations (MG crises/flares) or chronic disease (MG, rheumatoid arthritis, etc)."

Preclinical • CNS Disorders • Immunology • Inflammatory Arthritis • Myasthenia Gravis • Rheumatoid Arthritis • Rheumatology