Norfolk, VA, Jan 17, 2023
ReAlta Life Sciences today announced that the manuscript from ReAlta’s Phase 1 Healthy Volunteers study, titled, “RLS-0071, a dual-targeting anti-inflammatory peptide – biomarker findings from a first in human clinical trial” (TRMC-D-22-00014R1) has been published in Translational Medicine Communications.
In the study, ReAlta’s lead compound RLS-0071 demonstrated confirmed target engagement in healthy volunteers and an excellent safety profile. RLS-0071 showed dose-dependent classical complement pathway inhibition and myeloperoxidase target engagement consistent with its dual-targeting mechanisms of action. Biomarker data and target engagement assays demonstrated time-limited dose responses for humoral and cellular-based inflammatory effectors consistent with the known mechanisms of action of RLS-00171 and with return to baseline. RLS-0071 did not show any clinically significant changes in safety parameters, safety labs or ECG, and adverse events were minor and similar to the placebo group. Two-compartment kinetics were demonstrated consistent with rapid tissue distribution. The detailed results of the study can be found here.
“We are grateful to the Translational Medicine Communications group for accepting our manuscript. RLS-0071’s excellent safety profile and the target engagement data are extremely encouraging and give us confidence to continue moving forward in rare diseases,” said Kenji Cunnion, M.D., ReAlta’s Chief Medical Officer. “We look forward to exciting next steps of our clinical program this year.”
RLS-0071 is being developed as a treatment for hypoxic-ischemic encephalopathy (HIE) and other rare diseases. The company has IND clearance to conduct a Phase 2 clinical study in newborns with HIE, with enrollment beginning in 2023.