InflaRx, a biopharma in Jena (Germany) have positive results a phase IIa clinical trial of a first-in-class monoclonal antibody looking to treat acute inflammatory crises due to organ damage and trauma.
In serious infections, the body’s immune system activates inflammatory response mechanisms as cause of self-induced tissue and organ damage, such as oxygen radical formation, and enzyme or cytokine release by activated blood cells etc.
Similar mechanisms have been described in other infectious settings such as Malaria and Dengue Fever, but also in non-infectious inflammation, such as large operations (e.g. cardiac surgery), burns or trauma.
This inflammation (specifically ‘complement activation‘) can be life-threatening if over-activated and lead to septic organ dysfunction.
InflaRx’ founders have identified C5a (a protein mostly produced in the liver) as a key “amplifying factor” in complement inflammation, and this is the basis for InflaRx’s candidate IFX-1 – an antibody which targets the C5a protein.
The phase IIa trial (SCIENS) reached all primary endpoints and demonstrated safety, tolerability and biological proof of concept of IFX-1 in patients suffering from early septic organ dysfunction.
Up to 72 patients were enrolled in a dose escalation design, and the trial was conducted within the SepNet study trial group across 15 German Intensive Care Units.
This is an area of unmet medical need, and as InflaRx explains, so far there are no current therapies for this condition.
This trial could therefore mean a shift in Intensive care treatments, where doctor’s and patients struggle to cope with this acute medical condition.