MedPath

ZyVersa Therapeutics

🇺🇸United States
Ownership
Public
Employees
7
Market Cap
-
Website
http://www.zyversa.com
Introduction

ZyVersa Therapeutics, Inc. operates as a clinical stage biopharmaceutical company. It develops drugs for the treatment of renal and inflammatory diseases. The company was founded by Stephen C. Glover in 2014 and is headquartered in Weston, FL.

ZyVersa's IC 100 Shows Promise as Disease-Modifying Treatment for Parkinson's Disease

• New research validates that microglia-driven inflammation plays a pivotal role in Parkinson's disease progression, with studies showing IC 100 can block NLRP1 inflammasome activation and reduce toxic alpha-synuclein accumulation. • ZyVersa Therapeutics' Inflammasome ASC Inhibitor IC 100 demonstrates potential as a disease-modifying therapy by targeting both inflammasome formation and protein aggregation, addressing underlying disease mechanisms rather than just symptoms. • The findings, supported by the Michael J. Fox Foundation, could represent a significant advancement for the 10 million Parkinson's patients worldwide, with ZyVersa preparing to initiate proof-of-concept studies in animal models later this year.

Gazyva Shows Significant Improvement in Lupus Nephritis Treatment: Phase III REGENCY Trial Results

• Genentech's Phase III REGENCY trial demonstrates that Gazyva plus standard therapy achieved 46.4% complete renal response in lupus nephritis patients compared to 33.1% with standard therapy alone. • The study, published in NEJM, showed clinically meaningful improvements in complement levels and reductions in anti-dsDNA markers, indicating reduced disease activity and inflammation. • Results were consistent across all patient subgroups, including those with Class IV lupus nephritis and higher baseline proteinuria levels, while maintaining Gazyva's established safety profile.

Zymeworks Announces Strategic Priorities and Pipeline Expansion for 2025-2026

• Zymeworks is set to advance ZW171 and ZW191 in Phase 1 trials for solid tumors, part of their '5 by 5' R&D program. • The company plans to submit an IND application for ZW1528 in 2H-2026, targeting autoimmune and inflammatory diseases like COPD. • Regulatory decisions for zanidatamab in second-line biliary tract cancer in the EU and China are expected as early as 2Q-2025. • Zymeworks anticipates a cash runway into the second half of 2027, supported by $324 million in resources and milestone payments.

ZyVersa Therapeutics to Present Kidney Disease Drug VAR 200 at JPM Healthcare Conference 2025

• ZyVersa Therapeutics' CEO, Stephen C. Glover, will attend the JPM Healthcare Conference in January 2025 to discuss the company's pipeline. • VAR 200, a Cholesterol Efflux Mediator, is set to begin Phase 2a clinical trials for diabetic kidney disease in Q1 2025. • IC 100, an Inflammasome ASC Inhibitor, is being developed for obesity with metabolic complications, including cardiovascular disease. • ZyVersa is focusing on first-in-class drugs for inflammatory and renal diseases with significant unmet medical needs.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

ZyVersa Highlights Data on Inflammasome Inhibition for Type 2 Diabetes Prevention

• ZyVersa Therapeutics highlights data showing inflammasome inhibition protects pancreatic islet beta cells, preventing obesity progression to type 2 diabetes. • Research indicates inflammasome-driven inflammation severely damages pancreatic islets, leading to cell loss and metabolic dysfunction. • ZyVersa's Inflammasome ASC Inhibitor IC 100, an add-on to incretin therapy, showed improved metabolic status in obesity mouse models. • Phase 1 trials for IC 100 are planned for mid-2025, marking a step forward in obesity and related comorbidities treatment.
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