Shortly after floating a contingency plan for its asset, vilobelimab—which boasts an emergency use authorization (EUA) for COVID-19 in the U.S.—Germany’s InflaRx is drafting bigger changes to its organization as it looks to cut costs and focus attention on a separate candidate under development in inflammatory and immunological conditions.
Among the most acute impacts of the reshuffling, roughly 30% of the company’s staff will be laid off, accompanied by “substantial spending reductions,” InflaRx said in a Jan. 8 press release. Several online sources put the biotech’s employee count at 74 as of Dec. 31, 2024.
The company is looking to streamline its organizational structure and discontinue non-essential activities beyond the development of its lead asset, izicopan—an oral C5a receptor inhibitor in the clinic for hidradenitis suppurativa (HS), chronic spontaneous urticaria (CSU), and other inflammation and immunology (I&I) indications.
As resources are channeled toward izicopan, InflaRx will significantly reduce its commercial spending on vilobelimab, which goes by the trade name Gohibic for COVID-19. The drug won an FDA emergency use nod in 2023 to treat hospitalized COVID patients within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation.
InflaRx is not removing Gohibic from the U.S market and says it will maintain the ability to satisfy demand for the drug “on a reactive basis.” The company will also keep resources on hand to continue a BARDA-funded phase 2 platform study of Gohibic in acute respiratory distress syndrome (ARDS), dubbed Just Breathe.
InflaRx had been pursuing development of vilobelimab in other indications beyond COVID, but the company’s hopes for the asset waned after it scrapped a study of the C5a antibody in pyoderma gangrenosum (PG) last May over futility.
Then, in late December, InflaRx found a silver lining in the results, touting post hoc analyses of the terminated phase 3 trial that pointed to a “positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect.”
As it indicated late last year, InflaRx will continue to seek partnering opportunities for the drug in the U.S. and Europe, and it still anticipates meeting with the FDA to hash out a potential development path for vilobelimab in PG, the company said Thursday. If a new development path is indeed sketched out, InflaRx expects it would only move forward with the help of a partner.
Now, the company’s attention revolves almost exclusively around izicopan, which InflaRx believes could serve as a potential best-in-class C5a receptor inhibitor and “pipeline-in-a-product.”
As it stands, InflaRx is now in talks with the FDA on phase 2b study design in the HS indication, with its stated goal to both differentiate izicopan from existing therapeutic options and address “variability inherent in some HS trial outcomes.” The company stressed that it is “moving as quickly as is feasible” to advance its izicopan program in HS and plans to issue another update “in due course.”
HS is an autoinflammatory condition that attacks hair follicles, which can cause painful, recurring abscesses in areas of the body prone to sweating.
InflaRx noted that it believes izicopan’s potential extends well beyond HS into other I&I conditions, such as CSU, where the asset has reported topline phase 2a data. With “supportive” results in hand from two all-comer dosing cohorts in izicopan’s CSU trial, the company said Thursday that will close a third treatment cohort covering anti-IgE refractory patients in the trial, citing “low enrollment trends” in the group.
“InflaRx will utilize the existing data set to determine next steps for izicopan in CSU, which the company expects to communicate later this year,” InflaRx said in its release.
Meanwhile, in a bid to generate proof of concept data in other I&I indications “as efficiently as possible,” InflaRx says it’s now planning to run a pharmacokinetics bridging study in China this year. If successful, the study should enable “expedited subsequent proof of concept studies” in China and elsewhere, the company said.
As for the final piece of InflaRx’s izicopan strategy, the company stressed that it continues to look for potential collaboration partners to take its development work on the C5a receptor inhibitor to the next level.
“In an effort to enable the long-term success of InflaRx, we have made the decision to increase our capital efficiency and tightly focus the company,” CEO Niels Riedemann said in a statement Thursday. “Our goal with this realignment is to prioritize resources toward izicopan in hidradenitis suppurativa and additional areas in inflammation and immunology, allowing us to maximize its value as a significantly differentiated oral inhibitor of C5aR and pipeline-in-a-product.”
Given the layoffs and downturn in Gohibic commercial spending, InflaRx expects to take a one-time hit of $7 million, the majority of which will come in the form of a non-cash charge tied to an inventory write-off, the company explained in its release. A smaller portion of the charge will come in the form of restructuring costs, which include personnel-related expenses and “the termination or modification of certain third-party contracts,” InflaRx added.
By tightening its belt, InflaRx figures its cash runway will now extend out to “mid-2027.”