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InflaRx Takes Another Look at Shelved Drug After Finding Silver Linings in Failed Trial

MarketDash Editorial Team
3 days ago
After pulling the plug on a Phase 3 study earlier this year, InflaRx found new data patterns suggesting its experimental drug might actually work for a rare and painful skin condition, prompting fresh FDA discussions and a hunt for partnership opportunities.

InflaRx N.V. (IFRX) is making a case for resurrecting vilobelimab after fresh data analyses revealed encouraging signs in a Phase 3 trial that was shut down months ago. The company is now setting up talks with the FDA and exploring a partnership-driven strategy to move the program forward.

Here's the backstory: Last Tuesday, InflaRx shared multiple new analyses from its Phase 3 study testing vilobelimab in pyoderma gangrenosum, a rare and excruciating skin disorder. The trial was terminated earlier in 2025 after an Independent Data Monitoring Committee recommended stopping it early due to futility. Not exactly the outcome anyone hopes for.

But then the company took a deeper dive into the data. Those subsequent post-hoc analyses suggest a positive trend favoring vilobelimab, with signals pointing toward a potentially consistent treatment effect. In other words, maybe there's something worth salvaging here.

For context, pyoderma gangrenosum is a rare and painful skin condition where red bumps rapidly transform into large, deep, open ulcers, often surrounded by a purple, undermined border. Despite how it sounds, it's not caused by infection or actual gangrene.

The Path Forward Involves FDA Meetings and Partnership Talks

InflaRx now anticipates scheduling meetings with the FDA to discuss potential next steps for vilobelimab in pyoderma gangrenosum. Those conversations will likely focus on alternative endpoints that could be used in future clinical studies, essentially recalibrating how success gets measured.

But here's the strategic twist: The company doesn't plan to pour significant resources into vilobelimab development on its own. Instead, it wants to prioritize izicopan (INF904) development and will only advance vilobelimab in collaboration with a partner. That makes sense when you consider that back in November 2025, InflaRx revealed positive topline data from a Phase 2a basket study exploring INF904 in hidradenitis suppurative and chronic spontaneous urticaria.

The new analyses disclosed Tuesday cover the primary intent-to-treat analysis plus several post-hoc analyses examining the 54 patients enrolled when the study was terminated.

What the Numbers Actually Show

The primary clinical endpoint measured complete target ulcer closure on two consecutive visits. The result showed a difference favoring vilobelimab over placebo of 20.8% versus 16.7%, though this wasn't statistically significant.

Key secondary endpoints painted a more interesting picture. Complete disease remission, meaning complete closure of all ulcers, showed improvement favoring vilobelimab over placebo at 20.8% versus 5.6% (not statistically significant). Patients with greater than 50% reduction of target ulcer volume at week 26 also leaned toward vilobelimab at 36.4% versus 16.7% (again, not statistically significant).

Patients also reported feeling better based on the Dermatology Life Quality Index, with a mean percentage change at the end of treatment visit of -31.1% versus 3.4% for placebo. Overall, vilobelimab was well tolerated throughout the trial.

Post-Hoc Analyses Reveal Consistent Benefits

The really compelling part comes from additional post-hoc analyses, which demonstrated an overall treatment effect with vilobelimab compared to placebo.

One analysis used a mixed model repeated measures approach for percent change in target ulcer volume. This showed an average effect across all visits favoring vilobelimab over placebo at -45.4% (p=0.0428, covering Weeks 2 through 26 overall) when accounting for patients who discontinued for treatment-related reasons.

Even more striking, the analysis produced a statistically significant treatment difference every week from Week 14 (-57.6%, p=0.0357) through Week 26 (-63.2%, p=0.0122) for vilobelimab over placebo. That's a sustained and growing benefit over time.

The analyses also hint that extending treatment beyond 26 weeks with vilobelimab might deliver even better outcomes. That's the kind of finding that could reshape trial design going forward.

IFRX Price Action: IFRX stock closed at $1.09, up 7.92% on Friday.

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InflaRx Takes Another Look at Shelved Drug After Finding Silver Linings in Failed Trial

MarketDash Editorial Team
3 days ago
After pulling the plug on a Phase 3 study earlier this year, InflaRx found new data patterns suggesting its experimental drug might actually work for a rare and painful skin condition, prompting fresh FDA discussions and a hunt for partnership opportunities.

InflaRx N.V. (IFRX) is making a case for resurrecting vilobelimab after fresh data analyses revealed encouraging signs in a Phase 3 trial that was shut down months ago. The company is now setting up talks with the FDA and exploring a partnership-driven strategy to move the program forward.

Here's the backstory: Last Tuesday, InflaRx shared multiple new analyses from its Phase 3 study testing vilobelimab in pyoderma gangrenosum, a rare and excruciating skin disorder. The trial was terminated earlier in 2025 after an Independent Data Monitoring Committee recommended stopping it early due to futility. Not exactly the outcome anyone hopes for.

But then the company took a deeper dive into the data. Those subsequent post-hoc analyses suggest a positive trend favoring vilobelimab, with signals pointing toward a potentially consistent treatment effect. In other words, maybe there's something worth salvaging here.

For context, pyoderma gangrenosum is a rare and painful skin condition where red bumps rapidly transform into large, deep, open ulcers, often surrounded by a purple, undermined border. Despite how it sounds, it's not caused by infection or actual gangrene.

The Path Forward Involves FDA Meetings and Partnership Talks

InflaRx now anticipates scheduling meetings with the FDA to discuss potential next steps for vilobelimab in pyoderma gangrenosum. Those conversations will likely focus on alternative endpoints that could be used in future clinical studies, essentially recalibrating how success gets measured.

But here's the strategic twist: The company doesn't plan to pour significant resources into vilobelimab development on its own. Instead, it wants to prioritize izicopan (INF904) development and will only advance vilobelimab in collaboration with a partner. That makes sense when you consider that back in November 2025, InflaRx revealed positive topline data from a Phase 2a basket study exploring INF904 in hidradenitis suppurative and chronic spontaneous urticaria.

The new analyses disclosed Tuesday cover the primary intent-to-treat analysis plus several post-hoc analyses examining the 54 patients enrolled when the study was terminated.

What the Numbers Actually Show

The primary clinical endpoint measured complete target ulcer closure on two consecutive visits. The result showed a difference favoring vilobelimab over placebo of 20.8% versus 16.7%, though this wasn't statistically significant.

Key secondary endpoints painted a more interesting picture. Complete disease remission, meaning complete closure of all ulcers, showed improvement favoring vilobelimab over placebo at 20.8% versus 5.6% (not statistically significant). Patients with greater than 50% reduction of target ulcer volume at week 26 also leaned toward vilobelimab at 36.4% versus 16.7% (again, not statistically significant).

Patients also reported feeling better based on the Dermatology Life Quality Index, with a mean percentage change at the end of treatment visit of -31.1% versus 3.4% for placebo. Overall, vilobelimab was well tolerated throughout the trial.

Post-Hoc Analyses Reveal Consistent Benefits

The really compelling part comes from additional post-hoc analyses, which demonstrated an overall treatment effect with vilobelimab compared to placebo.

One analysis used a mixed model repeated measures approach for percent change in target ulcer volume. This showed an average effect across all visits favoring vilobelimab over placebo at -45.4% (p=0.0428, covering Weeks 2 through 26 overall) when accounting for patients who discontinued for treatment-related reasons.

Even more striking, the analysis produced a statistically significant treatment difference every week from Week 14 (-57.6%, p=0.0357) through Week 26 (-63.2%, p=0.0122) for vilobelimab over placebo. That's a sustained and growing benefit over time.

The analyses also hint that extending treatment beyond 26 weeks with vilobelimab might deliver even better outcomes. That's the kind of finding that could reshape trial design going forward.

IFRX Price Action: IFRX stock closed at $1.09, up 7.92% on Friday.

    InflaRx Takes Another Look at Shelved Drug After Finding Silver Linings in Failed Trial - MarketDash News