Fazpilodemab Clinical Trials Bispecific Antibodies Market Size 2023 Till 2029

Global Bispecific Antibody Market Witnessing Exponential Growth Says Kuick Research

Delhi, March 17, 2024 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Market Opportunity Insight 2029 Report Highlights:

  • Global Market Forecast Till 2029: > USD 36 Billion
  • Approved Bispecific Antibodies: 11
  • Yearly & Quarterly Sales Insight
  • Global & Regional Sales Insights
  • Insight On Bispecific Antibodies In Clinical Trials: > 600 Bispecific Antibodies
  • Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase
  • Fast Track Approval, Orphan Designation & Priority Status Insights
  • Approved Bispecific Antibodies Pricing  & Dosage Analysis
  • Top 30 Companies Developing Bispecific Antibodies Competitive Insight
  • 800 Pages Clinical & Commercial Opportunity insight

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Fazpilodemab, also known as BFKB8488A, is a fully humanized bispecific IgG1 antibody engineered to selectively bind and activate the Klothoβ/fibroblast growth factor receptor 1c (FGFR1c) receptor complex. This agonistic biologic, developed by Genentech, was under investigation as a potential therapeutic intervention for nonalcoholic steatohepatitis (NASH), a form of progressive liver disease characterized by fat accumulation, inflammation, and fibrosis in individuals without significant alcohol consumption. Fazpilodemab's unique molecular design aimed to leverage the Klothoβ/FGFR1c signaling pathway, a key regulator of metabolic processes and energy homeostasis, to mitigate the pathological manifestations associated with NASH through targeted receptor modulation.

In September 2023, Genentech unveiled findings from a phase 1b clinical trial evaluating the safety profile, tolerability, pharmacokinetic behavior, immunogenicity, and pharmacodynamic effects of fazpilodemab in patients diagnosed with type 2 diabetes mellitus (T2DM) or nonalcoholic fatty liver disease (NAFLD). The study design entailed randomizing participants to receive multiple administrations of fazpilodemab across varying dose levels and dosing schedules, or a placebo comparator, over a 12-week treatment period. The primary objective of this early-stage investigation was to assess the safety and tolerability of fazpilodemab in these patient populations.

The phase 1b study data revealed that fazpilodemab (BFKB8488A) exhibited an acceptable tolerability profile in patients with type 2 diabetes mellitus or nonalcoholic fatty liver disease. Treatment with this bispecific antibody was associated with favorable effects on lipid parameters, manifested as a decrease in triglyceride levels and an increase in high-density lipoprotein (HDL) cholesterol concentrations. Moreover, there were promising trends observed in the improvement of biomarkers indicative of liver function and health across both patient populations. Notably, in the NAFLD cohort, fazpilodemab administration led to a marked reduction in hepatic fat content, a hallmark feature of this chronic liver condition.

Previously, in a clinical trial that has since been terminated, fazpilodemab was evaluated for its potential in treating metabolic dysfunction-associated steatohepatitis (MASH). Among patients with MASH, fazpilodemab showed tolerability and an acceptable safety profile. While improvements in liver enzymes were noted following fazpilodemab administration, the early termination of the study and its limited sample size restrict the conclusive interpretation of clinical efficacy.

Therefore, the encouraging preliminary findings in select indications underscore fazpilodemab's potential to ameliorate key pathophysiological aspects of metabolic dysregulation and liver disease through its targeted modulation of the Klothoβ/FGFR1c signaling axis. While further investigation is warranted, these early clinical results highlight fazpilodemab's promise as a novel therapeutic approach for managing the multifaceted metabolic derangements associated with conditions like type 2 diabetes and nonalcoholic fatty liver disease.


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