InflaRx N.V. Inc. (NASDAQ: IFRX) stock gains by 1.14% during the current market trading session. InflaRx is a clinical-stage pharmaceutical business focusing on discovering and developing first-in-class, powerful, and selective C5a inhibitors using its patented anti-C5a technology.
IFRX stock’ Current Update
The first 10 evaluable patients in IFRX’s current Phase IIa open label research with vilobelimab in Pyoderma Gangraenosum have shown encouraging results.
As previously disclosed, 19 patients were enrolled in the proof-of-concept trial, including 12 in each of the first two dosage groups. Only 10 patients were evaluable for the effectiveness evaluation on day 99 because two of the 12 withdrew from the trial before reaching day 99 of therapy.
After IFRX interim run-in phase with three doses of 800mg on days 1, 4, and 8, patients were treated bimonthly with vilobelimab 800mg, 1600mg, or 2400mg for a total of 26 weeks (until day 189). After then, there was a three-month monitoring period. If at least five patients in the cohort had been managed without safety issues and the patient had a Physician Global Assessment score of 4 or above, a dosage increase to the next higher dosing group was feasible following disease assessment on day 57 of the study, as per protocol.
IFRX study’s primary goals are to assess the safety and effectiveness of vilobelimab in patients with PG. The reaction rate, defined as a PGA score of 3 of the target ulcer at various time periods and time to full closure of the target ulcer, is used to assess efficacy. At day 99, four of the ten patients who were evaluated for effectiveness fulfilled the response criteria, with three of them attaining full closure of the target ulcer. C5a levels were increased at baseline in the three patients who demonstrated clinical response with a PGA score of 3 and full target ulcer closure. Two of these three patients’ clinical responses were originally disclosed by InflaRx in February 2020.
On day 57 of the trial, the third patient who demonstrated complete target ulcer closure was moved from the 1600mg dosage group to the highest dose of 2400mg and the ulcer was closed following the dose escalation.