InflaRx has posted positive safety data from a Phase IIa trial of its treatment for early septic organ dysfunction. Having met the primary endpoints in the study, InflaRx is now sifting through the data ahead of planned meetings with regulators to discuss the design of a Phase IIb trial.
Jena, Germany-based InflaRx designed the 72-person trial to assess the safety, pharmacokinetics and pharmacodynamics of IFX-1, its intravenously administered monoclonal anti-C5a antibody. The drug came through this early test unscathed, setting InflaRx up to begin preparations for a Phase IIb trial that will look more closely at efficacy. In the Phase IIa trial, InflaRx spotted "positive trends" in data indicative of efficacy, such as organ dysfunction score, need for ventilator support and length of stay in intensive care, but its primary goals lay elsewhere.
The goal will shift in SCIENS II, its Phase IIb. "SCIENS II will likely be designed to demonstrate efficacy in a clinically relevant endpoint in the field of septic organ dysfunction," a spokesperson for InflaRx told FierceBiotech. Before InflaRx decides on what the endpoint will be, it plans to conduct a deeper analysis of the Phase IIa data, after which it will meet with regulators on both sides of the Atlantic. The meetings are intended to set InflaRx to file to start the study. In parallel, InflaRx is setting up a Phase II trial in which IFX-1 will be given to patients undergoing complex cardiac surgery.
With the Phase II surgery trial, which will assess the potential of IFX-1 in preventative settings, set to start later this year and the Phase IIb study on the horizon, at some point in the near future InflaRx will need to source cash to bankroll its activities. At this stage, the company is unwilling to commit publicly to a particular course of action, be it a partnership or public or private funding. "We are currently evaluating various different options for our future financing of the development programs," the spokesperson said.
InflaRx closed a Series B round, valued in "the double-digit million Euro space", in 2014. Bm|t, the investment fund for the German state of Thuringia, led the round.
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