Type: Potentially first-in-class monoclonal anti-human complement factor C5a antibody in development for COVID-19 as well as inflammatory indications that include hidradenitis suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum.
Status: InflaRx said July 21 it plans to advance IFX-1 into a Phase III trial that will be adequately powered for statistical analyses. The double-blinded, randomized, placebo-controlled study will be designedfor InflaRx to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia. InflaRx plans to conduct the study at sites in the U.S., Europe, South America and potentially other regions.
The company plans an interim analysis of Phase III data following the enrollment of 180 patients, with the potential for an early stop for efficacy or futility. The trial’s primary endpoint will be 28-day all-cause mortality, with other planned key endpoints to include assessments of organ support and assessment of disease improvement on the ordinal scale.
Korinna Pilz, MD, Global Head of Clinical R&D at InflaRx, noted in a statement that data from the 30-patient, Phase II portion of the study in patients with severe COVID-19 induced pneumonia suggested that IFX-1 treatment had a a positive impact on the all-cause mortality rate and other endpoints. The Phase II study was designed to compare IFX-1 plus best supportive care with best supportive care alone for up to 28 days: “Based on these encouraging results, we are excited to initiate the Phase III part of the trial, which we anticipate starting in the coming months.”
In March, InflaRx enrolled the first patient into a randomized clinical trial in the Netherlands that is investigating the safety and efficacy of IFX-1 in patients with severe COVID-19-induced pneumonia. The patient is being treated at Amsterdam University Medical Centers, with additional centers in Germany and potentially other European countries planned.
InflaRx said it had received from its Chinese licensee BDB initial positive human data from the first two patients treated in a Chinese clinical trial with BDB-001, an anti-C5a antibody produced in China by BDB from the IFX-1 cell line. That data is part of a larger study on the role of complement activation in COVID-19, made public through a preprint and not yet independently verified by InflaRx.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: