Developer intends to launch 2 trials next year to test oral vasculitis treatment
First will enroll AAV patients with kidney involvement; second targets steroid use
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A German biopharmaceutical company says it intends to launch two mid-stage clinical trials next year to test its oral treatment candidate izicopan — a next-generation therapy that developer Inflarx says may offer an “improved safety profile” and “more convenient dosing” — in people with ANCA-associated vasculitis (AAV).
Inflarx says the first of the pair of Phase 2 trials will evaluate the therapy candidate against a placebo in AAV patients with kidney involvement, which is common in individuals with this group of rare autoimmune diseases.
The second will assess whether izicopan can replace corticosteroids — a cornerstone therapy — in people with newly diagnosed or relapsing AAV who need treatment to induce remission, defined as no signs or symptoms of the disease. Corticosteroids are a type of anti-inflammatory medication commonly used to help control AAV but whose long-term use is associated with serious side effects.
The plans were announced in a company press release and shared at its Capital Markets Day, a virtual investor and analyst event held Nov. 3.
“Our Capital Markets Day underscores our conviction that izicopan has the potential to become a differentiated therapy for patients with ANCA-associated vasculitis and other [kidney] diseases,” said Niels C. Riedemann, MD, PhD, founder and CEO of Inflarx.
According to the company, the goal of both trials is “providing multiple data sets demonstrating differentiated efficacy and safety in multiple [AAV] settings.” Initial data from the trials are “anticipated in 2028,” per Inflarx.
AAV is marked by inflammation in small blood vessels, which can damage the kidneys and other organs.
Izicopan is designed to block the activity of the C5a receptor (C5aR) protein. In AAV, activation of a group of inflammatory proteins called the complement cascade triggers production of C5a, a signaling molecule that binds to C5aR at the surface of immune cells, contributing to blood vessel damage.
Izicopan may be better option than Tavneos, developer says
Inflarx has said that izicopan might offer a safer, faster, and more convenient alternative to Amgen’s Tavneos (avacopan), which also works by blocking C5aR.
Tavneos, an oral therapy taken twice daily, was approved in the U.S. to treat adults with microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA), the two most common forms of AAV. However, its approval has come under scrutiny due to allegations of data manipulation in clinical testing, and in other markets its approval has already been revoked.
Preclinical tests have suggested that izicopan is faster than Tavneos at reaching therapeutic levels, has the potential for once-daily dosing, and has a more favorable safety and metabolic profile. The therapy candidate has also been shown to reduce kidney damage in animal models of kidney injury, per the developer.
According to Inflarx, izicopan has also so far been tolerated well in clinical tests involving healthy volunteers or people with other disorders.
“C5aR [suppression] has been clinically and commercially validated, and izicopan was specifically optimized to build on that foundation,” Riedemann said. “Its rapid and sustained target [suppression], improved metabolic profile and potential for more convenient dosing support a compelling product profile.”
One of the upcoming trials, whose plans were previously announced, will test izicopan against a placebo for one year in about 70 AAV patients with kidney involvement. All participants will also receive standard of care therapies, including the approved med rituximab (sold as Rituxan and others, with biosimilars available) and a glucocorticoid taper.
The main goal is to explore whether izicopan can induce disease remission, improve kidney function, limit kidney damage, and reduce glucocorticoid use compared with the placebo. The study is planned to begin in early 2027, and it will recruit participants at sites in multiple countries over the course of about 18 months, or 1.5 years.
1 trial will test if drug can eliminate need for steroids in AAV
In the second Phase 2 study, all participants will receive izicopan. That trial will involve people with newly diagnosed or relapsing AAV in need of treatment to induce disease remission and will enroll participants irrespective of the organ(s) affected.
In its first planned portion, participants will undergo a rapid taper of glucocorticoids while receiving remission induction therapy, which may also include rituximab. If no serious safety events are reported, a strategy to completely replace glucocorticoids with izicopan will be explored in the second portion.
The main goals will be to evaluate whether the therapy can replace glucocorticoids during induction treatment without affecting patient safety. This study is expected to start later next year, with initial data expected the following year.
Inflarx said that plans for this trial were informed partly by data from early clinical testing of BDB-001, an experimental injection therapy that targets C5a and is being developed by the company’s Chinese partner Staidson Biopharmaceuticals.
Staidson is now sponsoring a China-based Phase 3 trial (NCT07168161) that’s testing BDB-001 in approximately 300 adults with newly diagnosed or relapsed MPA or GPA. Participants are randomly assigned to receive either BDB-001 or a corticosteroid in addition to induction treatment. The main goal is to see how many patients achieve disease remission after six months.
Inflarx is also developing izicopan as a potential treatment for other kidney conditions, specifically atypical hemolytic uremic syndrome and immunoglobulin A nephropathy.
“Combined with our focused development strategy, we believe izicopan is well positioned to address important unmet needs in AAV and potentially establish a broader [kidney-disease] franchise,” Riedemann said.
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