NodThera—under its new name Rezera—is planning an IPO as the biotech steps up its ambitions to get its NLRP3 inhibitor to market.
The Boston-based biotech has yet to set out how many shares it is planning to offer, or at what price. But the company used a Securities and Exchange Commission filing to explain that its top spending priority for the proceeds would be ruvonoflast.
The IPO haul will be used to take the brain-penetrant inhibitor of NOD-like receptor protein 3 (NLRP3) through a planned phase 3 study next year in peripheral artery disease (PAD), as well as start getting the company ready for a potential commercial launch.
PAD is a form of atherosclerotic cardiovascular disease marked by narrowed or blocked small arteries that reduce blood flow to the limbs, usually the legs.
Rezera—which rebranded from NodThera last month—had been touting ruvonoflast as a potential anti-inflammatory drug for patients with obesity. Earlier this month, the biotech unveiled phase 2 results evaluating the drug in combination with Novo’s Wegovy ingredient semaglutide.
That study showed that the ruvonoflast-semaglutide combo saw a statistically significant reduction in high-sensitivity C-reactive protein (hsCRP)—a marker of inflammation—compared with semaglutide alone. But by the time of the readout, the company had already decided that PAD was the way to go.
With around 20 million adults in the U.S. affected by the disease, Rezera is hoping it can tap an estimated $5 billion market opportunity.
“We selected PAD because it represents a significant unmet medical need in a large patient population and is associated with a high inflammatory burden and substantial disease morbidity despite broad use of lipid-lowering, antihypertensive and diabetes therapies,” Rezera explained in the filing.
The decision to home in on PAD as its lead indication for phase 3 development came in early September, when the company rebranded. That transformation into a company focused on getting ruvonoflast ready for market included bringing on a new leadership team in the form of CEO Geoff McDonough, M.D., a former CEO of Generation Bio, as well as Chief Medical Officer Jyothis George, Ph.D., a veteran of Amgen and Novo.
They joined a company that has been pushing the development of NLRP3 developers for over a decade. NLRP3 is the upstream driver of sterile inflammation—a term for inflammation caused by damage signals, such as cholesterol crystals or misfolded proteins, rather than by infection.
“By directly inhibiting NLRP3 upstream, we aim to broadly reduce the activity of the entire sterile inflammation pathway, thereby reducing [residual inflammatory risk] and modifying the course of cardiovascular and neurologic diseases,” the company explained in yesterday’s filing.
As well as taking ruvonoflast to the finish line, some of the IPO proceeds will be used to fund Rezera’s earlier-stage pipeline, according to Wednesday’s filing. The most advanced of these assets is trabzanoflast, another NLRP3 inhibitor, which has been optimized specifically to enter the central nervous system.
Trabzanoflast has already completed a phase 1 study and is being aimed at neuroinflammatory indications.
The company has 21 full-time employees split between its headquarters in Boston and an office in Cambridge, U.K. It’s no surprise that Rezera is seeking an IPO to fund its big ambitions—the company’s cash had dwindled to just $3.9 million by the end of June, according to the filing.
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