InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG).

“We are happy to see more patients responding with the highest dose of vilobelimab in patients with Pyoderma Gangraenosum,” commented Dr. Korinna Pilz, Chief Clinical Development Officer of InflaRx. “There is a need for better treatment options for this painful and debilitating condition. With the good safety profile and promising efficacy results we have seen in this trial, we will seek FDA guidance on next steps towards a pivotal program.”

As previously announced, a total of 19 patients were enrolled in the multi-center, proof-of-concept study, with seven patients enrolled in the third cohort. Over a treatment period of 26 weeks, patients were treated biweekly with vilobelimab 800mg, 1600mg or 2400mg, after an initial run-in phase with three doses of 800mg on days 1, 4 and 8. Following the treatment period, patients continued to be observed for a period of two months, which is ongoing for the third cohort. Per protocol, a dose increase to the next higher dosing group was possible upon disease assessment on day 57, if at least five patients in the cohort had been treated without safety concerns and the patient was assessed with a Physician Global Assessment (PGA) score of 4 or higher. The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG. Efficacy is being evaluated by a responder rate defined as a PGA score of ≤3 of the target ulcer at various timepoints and time to complete closure (remission) of the target ulcer.

In the third dosing cohort at 2400mg biweekly, all seven patients were evaluated at least on the day of last drug administration. Six of the seven patients achieved clinical remission with a PGA score of ≤1, which reflects a closure of the target ulcer. All patients in cohort 3 had elevated C5a levels at baseline that were continuously suppressed after initiation of vilobelimab.

InflaRx previously reported data for ten evaluable patients in the first two dose cohorts at day 99. The patient in the second dosing cohort demonstrating complete target ulcer closure had been increased from the 1600mg dose group to the highest dose of 2400mg dose on day 57 of the study, and the ulcer closed after the dose escalation. At day 99, this patient had a PGA score of 1, and by the end of the treatment period at day 189 had a PGA score of 0.

Overall, vilobelimab was well tolerated. From all cohorts, two patients had related serious adverse events (SAEs) that were reported: One patient experienced an erysipelas leading to hospitalization (judged as non-related by sponsor); another developed a rash due to a delayed hypersensitivity reaction and withdrew from study (which had been previously disclosed from cohort 2). No dose-related adverse events (AEs) were found. Overall, the observed AE profile was in line with the underlying diseases.

InflaRx will host a conference call and live audio webcast to discuss the clinical data from this study today at 8:30 am EDT / 2:30 pm CEST. To participate in the conference call, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call: https://services.choruscall.de/DiamondPassRegistration/register?confirmationNumber=9635740&linkSecurityString=10c5273014

Alternatively, if you have not registered in advance, you can enter the conference assisted by an operator. To reach an operator, please dial one of the following numbers:

To access the webcast online, please use the following link:https://services.choruscall.com/mediaframe/webcast.html?webcastid=5Pe5acAk

After the presentation, a Q&A session will be held. Participants may submit questions via the integrated chat window online or ask questions live by phone. The archived webcast will be made available in the Investors section of the Company’s website at www.inflarx.com.