InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904 - Seite 2

The safety analysis of INF904 in the MAD part of the Phase I study demonstrated that it was well tolerated in participants over the entire dose range and resulted in no safety signals of concern. The overall percentage of adverse events (AEs) in INF904 treated participants was 77.8%, which was lower than the 83.3% observed in the placebo group. There were no serious or severe AEs observed at any dosing level.

Analysis of the PK profile showed that potential target AUC_0-12h, C_max, and trough values were achieved rapidly within 14 days of 30 mg BID dosing. INF904 exposure further increased proportionally with dosing up to 90 mg BID. These results were demonstrated even when participants ingested the drug in a fasted state, suggesting that food is not required to achieve potentially therapeutic drug levels.

Analysis of the PD profile showed that the blocking activity of C5a-induced neutrophil activation by INF904 reached equal to or above 90% over the 14-day dosing period for all tested doses in an ex vivo challenge assay where physiological and disease-relevant levels of C5a were added to blood samples provided by the trial participants.

InflaRx previously reported the data from the SAD part of the trial with 62 healthy volunteers in a press release and conference call. The SAD part showed a favorable dose-proportional systemic exposure with desired blocking activity (>90%) of C5a-induced neutrophil activation at disease-relevant C5a levels for doses of 30 mg to 240 mg 24 hours post-administration.

In parallel, InflaRx has progressed with the development of a commercially viable formulation of INF904 which the Company plans to introduce into Phase II development towards the end of 2024.

InflaRx is currently conducting additional required pre-clinical studies, including long-term chronic toxicology studies, to enable longer-term dosing of INF904 for chronic inflammatory diseases. InflaRx currently plans to initiate a short-term dosing Phase II study towards the end of 2024, followed by a longer-term dosing Phase II study in 2025. Further details of this clinical development plan with selection of indications will be announced in due course.

Conference call scheduled for today, January 4, 2024

InflaRx will host a conference call today, January 4, 2024 at 8:30 a.m. EST (14:30 CET) to provide more details about the announced topline results of the MAD part of its Phase I study of INF904 in healthy human subjects. To participate in the conference call, participants may pre-register here and will receive a dedicated link and dial-in details to easily and quickly access the call. A replay will be available on the InflaRx website in the Investors – Events & Presentations section after the live conference call has concluded.