InflaRx pauses trial

 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today reported that the Company has received an advice letter from the U.S. Food and Drug Administration (FDA) related to its Phase III program with vilobelimab for the treatment of hidradenitis suppurativa (HS). The feedback indicates that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint in the Phase III trial. The FDA advice was provided nearly three months after the Company’s protocol submission and contrasts with the FDA advice provided to the Company in a Type A meeting held in Q3 2021. In the minutes of that meeting, FDA provided advice on how to implement, name and validate the meaningfulness of the modified HiSCR, a new primary endpoint suggested by the Company, that would measure the reduction of all three types of inflammatory lesions in HS – inflammatory nodules, abscesses and draining tunnels. A reduction in draining tunnels is not captured by the HiSCR. Within the Type A written response, FDA did not recommend the traditional HiSCR as the primary endpoint measure. Following the advice received in the Type A meeting, earlier this year, InflaRx announced the initiation of a Phase III trial, designed to study patients with moderate to severe HS disease suffering from actively draining tunnels.

Given the unexpected details of the feedback from the FDA, InflaRx will pause activities related to the Phase III trial. The Company will seek to clarify the advice received and determine next steps, which will be communicated accordingly. The FDA has not issued a clinical hold.

As previously announced, InflaRx completed a Type A meeting with the FDA in Q3 2021 to align on the Phase III HS study design. In this meeting, FDA and InflaRx discussed together a new primary efficacy endpoint for a pivotal study program that focuses on patients with active draining tunnels and includes measuring the reduction of all three types of inflammatory lesions. InflaRx incorporated the FDA’s input and submitted the Phase III protocol to the Agency in late November 2021. The FDA had no comments during the 30-day nor the 60-day review period. In Q1 2022, InflaRx determined it was appropriate to begin study activities, as the Company did not expect any critical protocol review issues to be pending with FDA.

https://finance.yahoo.com/news/inflarx-provides-development-plans-vilobelimab-123000625.html