InflaRx has enrolled the first patient in a Phase IIb trial of IFX-1 for the treatment of patients who are suffering from moderate or severe Hidradenitis Suppurativa (HS).
HS is a painful, chronic and debilitating inflammatory skin disease with limited treatment options.
InflaRx plans to conduct the trial in about 50 sites in several countries, including the US, Germany, Greece, Denmark and the Netherlands.
The trial will enrol roughly 175 patients in five dose groups.
Following a placebo-controlled period of 16 weeks the trial will see a 28-week open-label extension phase to evaluate long-term efficacy and safety.
The trial’s primary endpoint is the assessment of a dose response signal, measured by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16 as the primary endpoint.
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Additional objectives of the study include the evaluation of safety and tolerability of IFX-1 as well as an assessment of other efficacy and patient-reported outcome parameters.
Trial principal investigator Dr Evangelos Giamarellos-Bourboulis said: “New treatment options for moderate to severe HS are of immense importance to patients and clinicians as the current treatment options for many patients with HS are limited.
“The C5a blockade with IFX-1 offers an entirely new mode of action to tackle this disease. The trial design is based on the exciting results from the previously conducted Phase IIa study.”
IFX-1 is a monoclonal anti-complement factor C5a antibody that can effectively block the biological activity of C5a and demonstrate high selectivity towards its target in human blood.
It has so far successfully completed three clinical Phase II studies and has treated more than 150 patients.