ZyVersa Therapeutics has enlisted the CRO PPD to manage its upcoming Phase IIa focal segmental glomerulosclerosis (FSGS) study, said CEO Stephen Glover. The company is initiating a roadshow for crossover funding, with an IPO in the cards in 3Q20 or 1Q21, he added. FSGS is a leading cause of kidney failure in adults.
Weston, Florida, US-based ZyVersa has a full-service relationship with PPD for the study and has worked with the CRO for different tasks such as site selection for the ongoing study, said Glover, adding PPD has a lot of experience in running kidney disease trials.
The Phase IIa is planned as an open-label trial and will be conducted at 15 sites in the US, enrolling a total of 24 patients on two arms, testing a 3g and 6g dose of VAR 200 for 12 weeks, said Glover. Following the 12-week period, the patients will move into an open-label extension part, he added. In parallel, the trial will also include a provision for compassionate use for patients with Alport syndrome and minimal change nephropathy, noted the CEO.
The Phase IIa will evaluate VAR 200 based on quantifiable endpoints like a change in protein levels and estimated glomerular filtration rate (eGFR), said Glover. ZyVersa’s VAR 200 targets the lipid and cholesterol trapped in the cells around podocytes in kidney disease, which affects their ability to maintain efflux, he explained. Their inability to maintain efflux causes podocytes to detach and break down, leading to protein leakage in urine. VAR 200 is designed to act on the attachment of the podocytes to the cell membrane, allowing the extraction of cholesterol and lipids from cells, said Glover.
ZyVersa is also at the start of a roadshow planned for a potential crossover round with institutional investors and has enlisted Bank of America for the same, said Glover. The plan is to complete the private investment in the next 90 days, he noted, adding the fundraising amount will be decided based on investor appetite. The company has raised funds through founders, family offices and high-net-worth individuals in the past, he said. ZyVersa also raised $10m from the South Korean company Incon in December 2018, under its previous avatar Variant Pharmaceuticals, to support VAR 200’s preclinical and clinical development.
The company plans to IPO in 3Q, but if it does not happen then, the IPO will take place ideally in 1Q21, said Glover. The timing of the IPO depends not only on market conditions but also other events like the general elections that may have an impact on the field later this year, he noted.
The company’s second anti-inflammatory drug candidate, IC 200, is an inflammasome inhibitor that targets the upstream innate immune system. The therapy is being evaluated in nine animal models, which are multiple sclerosis, lupus nephritis, spinal cord injury, traumatic brain injury, type 1 and type 2 diabetic kidney disease, nonalcoholic steatohepatitis, stroke and acute lung injury.
Preclinical work should complete in 3Q, said Glover. After that the lead indication for IC 200 will be chosen for a Phase I study that will likely start in 1Q21, he noted.
Manasi Vaidya is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.