Pyoderma gangraenosum (PG) is a rare auto inflammatory disease which affects the skin. It unfortunately has no currently approved therapies. However, recent preliminary results from a Phase 2a trial have shown extreme promise for an investigative treatment.
Phase 2a Trial
This trial, run by InflaRx N.V., is examining the impact of IFX-1 on patients diagnosed with PG. 5 Patients have been treated so far and the trial is ongoing.
The trial is being conducted at the University of Toronto under the direction of Afsaneh Alavi.
The first 5 patients have received 800mg of the therapy biweekly for a total of 12 weeks. Before this dosing period, the participants were administered the therapy and observed for three months. Two of the patients have experienced complete healing since their treatment period. These individuals had not responded to any standard therapies for PG. Additionally, they both had elevated C5a levels within their plasma at baseline.
Objectives
The primary objectives of this study are to examine the efficacy and safety of this new treatment. Efficacy is measured by the closure of a target ulcer. The aforementioned two patients achieved this.
For the first patient, full healing was experienced not only in the target ulcer but in all of their affected areas. These results have been sustained for two months (so far) following the stop of treatment.
For the second patient, almost all other areas have been completely healed. They are nearing the end of their dosing period.
A third patient who has finished the dosing period had wound healing activity within the first few weeks of treatment but unfortunately closure did not ensue.
The final two patients are still in their treatment period. These individuals have severe disease. They have not shown healing yet. But, both of these individuals have been named eligible for an escalated dose of the therapy.
For all patients, the therapy was well tolerated and no serious AE’s were reported.
Researchers are encouraged by these findings and are excited for the future results of this study. They expect total enrollment to be around 18 patients. Two additional doses will be studied. The researchers expect that a higher dose of the therapy will be better able to control C5a levels.
You can read more about this investigative research here.
