First patient dosed in phase 3 vilobelimab trial for pyoderma gangrenosum
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Key takeaways:
- Ulcerative pyoderma gangrenosum is a rare disease with no current treatment.
- Vilobelimab has been granted orphan drug and fast track designations by the FDA.
InflaRx has initiated a phase 3 study of vilobelimab in patients with ulcerative pyoderma gangrenosum, the company announced in a press release.
The multinational, randomized, double-blind, placebo-controlled trial will include one arm in which patients receive 2,400 mg of vilobelimab every other week, as well as a low dose of corticosteroids, which will be tapered from day 1 through the first 8 weeks of the trial. The trial’s second arm will include patients who receive placebo, as well as the same dose of corticosteroids.
Complete closure of the target pyoderma gangrenosum (PG) ulcer by week 26 is the trial’s primary endpoint.
“We are pleased that the first patient has been dosed in the U.S. in our pivotal phase 3 study with vilobelimab for the treatment of ulcerative pyoderma gangrenosum. There are currently no approved treatments for this debilitating disease in either the U.S. or Europe, and therefore, there remains a high unmet medical need for these patients,” Camilla Chong, MD, chief medical officer of InflaRx, said in the release.
A rare, non-infectious, neutrophilic dermatosis recurrent skin disorder, ulcerative PG causes painful, necrolytic, cutaneous ulcers.
Vilobelimab, a first-in-class monoclonal anti-human complement factor C5a antibody, blocks the C5a activity, leaving the c5b-9 membrane attack complex intact, according to the release.
The FDA has granted orphan drug and fast track designations to InflaRx, whereas the European Medicines Agency has granted an orphan drug designation.
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