ZyVersa Therapeutics’ CEO, Stephen C. Glover, Featured on Benzinga All Access
- ZyVersa plans to initiate a Phase 2a trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024, with preliminary data anticipated by mid-year 2024.
- ZyVersa plans to complete GLP toxicology studies with IC 100 and submit an Investigational New Drug (IND) application in the fourth quarter of 2024, followed by initiation of a Phase 1 trial.
- Renewed optimism in the biopharma macroeconomic environment in 2024, evidenced by an increasingly positive fundraising environment, and upticks in IPOs and mergers and acquisitions across the industry.
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Insights
The recent developments from ZyVersa Therapeutics, particularly the advancement of VAR 200 and IC 100, are indicative of the company's strategic focus on addressing significant gaps in renal and inflammatory disease treatments. The initiation of a Phase 2a trial for VAR 200 targets a novel pathway in diabetic kidney disease (DKD) management, addressing lipid accumulation which is currently not targeted by existing therapies. This could represent a substantial market opportunity, given the prevalence of DKD and the lack of effective treatments for this aspect of the disease.
Furthermore, the progression of IC 100 towards IND submission and subsequent Phase 1 trial underscores ZyVersa's commitment to expanding its portfolio into broader inflammatory conditions. The company's mention of a 'positive fundraising environment' suggests a favorable investor sentiment which could be beneficial for ZyVersa's capital-raising efforts and for similar companies in the biopharmaceutical industry.
ZyVersa's planned milestones for 2024, particularly the Phase 2a trial of VAR 200 and the IND application for IC 100, may have significant implications for the company's stock valuation. Preliminary data from the VAR 200 trial, expected by mid-year, will be a critical inflection point for investor confidence and could drive stock volatility. Additionally, the CEO's commentary on a 'renewed optimism' in biopharma and an 'increasingly positive fundraising environment' may reflect broader market trends that could influence investment in the biotech sector. The anticipation of these events should be closely monitored by investors as they can lead to substantial shifts in market sentiment and stock performance.
The therapeutic potential of ZyVersa's VAR 200 in addressing the unmet need in DKD by targeting lipid accumulation is a significant scientific development. Lipid accumulation contributes to kidney damage and a therapy that effectively mediates cholesterol efflux could revolutionize the treatment paradigm. Similarly, the development of IC 100 as an Inflammasome ASC Inhibitor may offer new avenues for treating a range of inflammatory diseases by blocking the initiation and perpetuation of inflammation. The outcomes of these trials will not only have clinical implications but could also set a precedent for future research and development in the field of renal and inflammatory diseases.
WESTON, Fla., Jan. 10, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, addressed the 2024 outlook for ZyVersa and the biotechnology industry in a recent interview on Benzinga All Access.
To view the segment, click here.
During the interview, Mr. Glover described the significant unmet need and market opportunity in kidney disease, and how ZyVersa’s Cholesterol Efflux MediatorTM VAR 200 has the potential to improve kidney function and reduce kidney disease progression. Current treatments target glomerular hypertension and inflammation, but there are no treatments that target lipid accumulation, which is known to contribute to structural damage, proteinuria, and progression of kidney disease. ZyVersa plans to initiate a Phase 2a trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024, with preliminary data anticipated by mid-year 2024.
Mr. Glover also discussed ZyVersa’s proprietary Inflammasome ASC Inhibitor IC 100, which is designed to block initiation and perpetuation of damaging inflammation contributing to a multitude of inflammatory diseases. ZyVersa plans to complete GLP toxicology studies with IC 100 and submit an Investigational New Drug (IND) application in the fourth quarter of 2024, followed by initiation of a Phase 1 trial.
In addition to highlighting ZyVersa’s anticipated 2024 milestones, Mr. Glover offered his views on the renewed optimism in the biopharma macroeconomic environment in 2024, as evidenced by an increasingly positive fundraising environment, and upticks in IPOs and mergers and acquisitions across the industry.
About ZyVersa Therapeutics, Inc.
ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes phase clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the filtering system of the kidneys. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. ZyVersa’s pipeline also includes proprietary inflammasome ASC inhibitor IC 100 that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing. A discussion of these and other factors, including risks and uncertainties with respect to ZyVersa, is set forth in ZyVersa’s filings with the Securities and Exchange Commission, including ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
Corporate and IR Contact
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641
Media Contacts
Casey McDonald
cmcdonald@tiberend.com
646-577-8520
Dave Schemelia
Dschemelia@tiberend.com
609-468-9325
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