Graft-versus-Host Disease

Graft-versus-Host Disease

Acute Graft-versus-Host Disease (aGvHD) is an inflammatory disease process that frequently occurs after bone marrow transplantation where the transplanted white blood cells believe the host tissue to be foreign and therefore attack the new host (Phases 1 and 2 in figure below). The disease commonly affects skin, intestines, or liver leading to rash, diarrhea, and liver injury (Phase 3 in figure below). Moderate or severe disease typically results in hospitalization and can lead to death or chronic GvHD. The disease process involves multiple white cell types including neutrophils, which are not addressed by current therapies. Neutrophils are implicated in the more severe forms of aGvHD, particularly intestinal disease.

Müskens et al., Cells 2021, 10(8), 2051; https://doi.org/10.3390/cells10082051

The dual-targeting mechanism of RLS-0071 (pegtarazimod), ReAlta’s lead compound, is well suited for treating this rare life-threatening disease and potentially other disorders in hematology-oncology that all have a high unmet medical need.

Pre-clinical data suggests that pegtarazimod improves mortality and decreases organ damage in an animal model of aGvHD. These data, coupled with the excellent safety profile of pegtarazimod and mechanism of action data in humans highly pertinent to the pathogenesis of aGvHD, provides confidence that pegtarazimod is well suited to improve outcomes for these patients.

Our Goals:

• We aim to improve the speed of healing and decrease death and relapse in GvHD
• We aim to decrease the risk of progression to chronic GvHD
• We aim to decrease the need for and toxicities from steroids

ReAlta is conducting a Phase 2, open label clinical trial of RLS-0071 (pegtarazimod) in hospitalized patients with acute graft-versus-host disease (aGvHD). For further details on this trial, please visit clinicaltrials.gov (NCT06343792). https://clinicaltrials.gov/study/NCT06343792?term=NCT06343792&rank=1