Vilobelimab has received Fast Track and Orphan Drug designations from the FDA, as well as an Orphan Drug designation from the European Medicines Agency for the treatment of PG.
InflaRx announced a significant milestone in the research for ulcerative pyoderma gangrenosum (PG) treatment. The company revealed that the first US patient has been dosed in the Phase III study (NCT05964413) assessing the efficacy and safety of vilobelimab, an intervention for this rare, neutrophilic, and inflammatory skin disorder characterized by painful and destructive cutaneous ulcers.
“We are pleased that the first patient has been dosed in the US in our pivotal Phase III study with vilobelimab for the treatment of ulcerative PG. There are currently no approved treatments for this debilitating disease in either the US or Europe, and therefore, there remains a high unmet medical need for these patients,” said Camilla Chong, MD, chief medical officer of InflaRx, in a press release. “The Phase III study builds on our promising Phase II clinical results, and we look forward to the continual collaboration with external experts with the ultimate goal of helping patients that are suffering from this devastating condition.”
The global, randomized, double-blind, placebo-controlled trial will encompass patients from various regions, including the US, Europe, and Australia. The trial arms will administer vilobelimab (2400mg every other week) alongside a low dose of corticosteroids, and a placebo with the same corticosteroid regimen. Corticosteroid treatment will commence on day 1 and be tapered off within the initial 8 weeks. The primary endpoint of the study aims to achieve complete closure of the target ulcer within 26 weeks post-treatment initiation.
The study adopts an adaptive trial design with an interim analysis, which will remain blinded for the sponsor and investigators, while the independent data safety monitoring committee will receive unblinded data. This interim analysis will evaluate the observed difference in complete target ulcer closure between the two arms. Based on predefined rules, it will determine potential adjustments to the trial's sample size or, in cases of futility, consider halting the trial. The enrollment period is projected to extend over a minimum of two years, contingent on the total trial size post-sample size adaptation.
InflaRx's vilobelimab has received Fast Track and Orphan Drug designations from the US Food and Drug Administration, as well as an Orphan Drug designation from the European Medicines Agency for the treatment of PG.
PG is an autoimmune disease in need of additional understanding. Histologically, it exhibits substantial neutrophil infiltration, suggesting activated neutrophils as potential disease drivers. Typically affecting individuals aged 40 to 60, PG often co-occurs with other autoimmune disorders, compounding the challenges faced by patients. Currently, there are no approved drugs for PG treatment in the US or Europe, and no established standard of care based on controlled studies.
Vilobelimab, a first-in-class monoclonal anti-human complement factor C5a antibody, offers a targeted approach by effectively blocking the biological activity of C5a. It demonstrates high selectivity towards its target in human blood, leaving the formation of the membrane attack complex intact as a crucial defense mechanism of the innate immune system. Pre-clinical studies have shown vilobelimab's potential in controlling inflammation-driven tissue and organ damage by specifically blocking C5a, a key amplifier of the inflammatory response. In April, vilobelimab was approved for emergency use in the US to treat COVID-19 for hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.
InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum. InflaRx. November 6, 2023. Accessed November 7, 2023. https://www.inflarx.de/Home/Investors/Press-Releases/11-2023-InflaRx-Announces-First-Patient-Dosed-in-Phase-III-Trial-with-Vilobelimab-in-Pyoderma-Gangrenosum.html