Biohaven Showcases Broad Innovative Portfolio and Pipeline Updates Across Multiple Therapeutic Areas including Immunology, Neuroscience, Metabolic Disorders and Oncology at Annual Investor R&D Day
29 May 2024
Phase 1Clinical ResultPhase 2
BHV-1300 demonstrates dose-dependent and rapid IgG reductions within hours of administration
No SAEs, no severe AEs, most AEs were mild, deemed unrelated to study drug and resolved spontaneously
No clinically significant changes in LFTs across any dose cohorts to date
Recently initiated a total of 5 pivotal clinical trials with selective Kv7 activator, BHV-7000, targeting focal epilepsy, idiopathic generalized epilepsy, bipolar disorder and major depressive disorder
Anticipates Myostatin program topline data for Phase 3 Spinal Muscular Atrophy (SMA) study in 2H2024
Reports new preclinical data highlighting potential for taldefgrobep alfa as monotherapy and in combination with GLP-1 agonists for weight loss:
Taldefgrobep alfa in combination with GLP-1 in the diet-induced obesity preclinical model showed greater reductions in body weight and fat mass, and a larger increase in lean muscle mass, compared to GLP-1 alone
Taldefgrobep alfa demonstrated direct effects on fat reduction as measured by changes in adipocytes independent of increasing muscle mass
Releases positive Phase 1 data with BHV-8000, a brain-penetrant TYK2/JAK1 inhibitor, showing preliminary safety and achievement of target concentrations with reductions in inflammatory biomarkers in SAD/MAD study
Key updates for BHV-8000 include favorable regulatory feedback enabling initiation of registrational programs for the prevention of ARIA associated with amyloid lowering drugs and Parkinson's disease
As announced in an earlier press release today, first patient dosed with Biohaven's novel Trop-2 antibody drug conjugate (ADC), BHV-1510, in Phase 1/2 trial, as monotherapy and initiating combination with Regeneron's anti-PDL1 Libtayo®(cemiplimab-rwlc), in advanced or metastatic epithelial tumors
NEW HAVEN, Conn., May 29, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies, provides an overview of its development and regulatory advances across multiple therapeutic areas, and highlights the progress of its innovative degrader pipeline at the Company's 2024 Investor R&D Day today, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. Members of Biohaven's senior management team and key opinion leaders will share updates with investors and research analysts. The presentation slides will be available on the Events and Presentations page of the Biohaven website. An audio webcast will be available within 24 hours of the presentation.
Continue Reading
Preview
Source: PRNewswire
Figure 1: Biohaven presented the first human dosing experience with a MoDE degrader of IgG at its annual R&D Day. Preliminary data shows rapid, dose-dependent, maximal mean reductions (% change from baseline) in IgG for each cohort observed within 96hrs after administration of BHV-1300 in its ongoing Phase 1 Study. (NOTE: the Box plot shows the placebo adjusted mean as a diamond and the red stars represent model predicted values. The top and bottom of the box represent the 75th and 25th percentiles of the data. The whiskers (“T” shapes) are drawn from the top and bottom of the box to the most distant observation within 1.5 times the interquartile range (1.5x IQR). Observations more than 1.5x IQR from the top or bottom of the box are shown as dots; preliminary data presented from Study 1300-101 is from an ongoing study and subject to change as database not yet cleaned or locked; IgG1-4 analyzed at Mayo Clinic Laboratories, Rochester MN).
Preview
Source: PRNewswire
Figure 2: Biohaven’s novel TRPM3 antagonist has successfully completed Phase 1 study. Target plasma concentrations exceeded the EC90 by 20 minutes and were sustained above EC90 for several hours at all dose levels, confirming a potentially attractive PK profile for acute treatment of migraine and pain relief.
Preview
Source: PRNewswire
Figure 3: New preclinical data presented at Biohaven’s R&D Day showing taldefgrobep alfa directly lowered lipid storage in adipocytes. This direct effect on adipocytes is in addition to the muscle enhancing effects of taldefgrobep alfa.
Preview
Source: PRNewswire
Figure 4: Pharmacodynamic data from BHV-8000, brain penetrant TYK2/JAK1 inhibitor, from Biohaven’s Phase 1 study showing biomarker reduction of inflammatory pathways including hs-CRP and IFN-beta which are thought to drive the pathology of a numerous neurodegenerative disorders.
Preview
Source: PRNewswire
Preview
Source: PRNewswire
Figure 6: BHV-1510 toxicokinetic data demonstrates a highly stable ADC with minimal free payload in circulation.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.