InflaRx Completes Enrollment of Vilobelimab Phase IIa Study in Pyoderma Gangraenosum
- Target enrollment of 18 patients reached across three different dose groups
- Interim results will be available by the end of 2021 with final results expected in 2022
- Initial positive data from the first 5 patients previously announced in Q1 2020
JENA, Germany, April 15, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the achievement of target enrollment of the Phase IIa open label study of vilobelimab in patients with Pyoderma Gangraenosum (PG).
Dr. Korinna Pilz, Global Head of Clinical Research and Development of InflaRx, commented: “The full enrollment of our PG study is a significant milestone for the clinical development of vilobelimab as we continue to build the evidence that C5a is an important target for neutrophil-driven skin diseases. PG is a devastating autoimmune disease, and we hope our program can play a vital role in helping these patients.”
This open-label Phase IIa proof-of-concept study has reached the target enrollment goal of 18 patients with moderate to severe PG at sites in the US, Canada and Europe. Patients in three different ascending dose groups are being treated with vilobelimab for 27 weeks with a two-month follow-up period. The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG. Efficacy will be evaluated by (i) a responder rate defined as Physician Global Assessment ≤3 of the target ulcer at various timepoints and (ii) time to complete closure of the target ulcer. Both endpoints will be compared with historical data. Additional clinical endpoints include a photographic documentation and analysis of the ulcer size and several patient-reported outcome parameters, such as pain score and Dermatology Life Quality Index (DLQI).
In 2020, InflaRx announced positive initial data from the first five patients in the lowest dose group. Of these five initial patients, two patients achieved complete closure of the target ulcer and complete healing of all other PG ulcers. The drug was well tolerated and no drug-related severe adverse events (SAEs) have been recorded to date in the study.
A second interim analysis, including six patients treated in the second dose group until day 99, will be available by the end of 2021. Final results from all patients, including the highest dose group, are expected in 2022.