NORFOLK, Va.– ReAlta Life Sciences (“ReAlta”), Inc., a clinical stage, rare disease company addressing life-threatening diseases through harnessing the power of the immune system, today announced first-in-human Phase 1 clinical data on RLS-0071, the Company’s complement inhibitor and innate anti-inflammatory product candidate. RLS-0071 demonstrated an excellent safety profile and confirmed target engagement in healthy volunteers. RLS-0071 is being developed as a treatment for hypoxic-ischemic encephalopathy (HIE) and other rare diseases. The data are being presented at the American Academy of Neurology 2022 Annual Meeting to be held in person in Seattle on April 2 to 6, 2022, and virtually on April 24 to 26, 2022.
“Results of this first-in-human study are an important step in its RLS-0071’s development because of its excellent safety profile and evidence of target engagement,” said Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer. “With the clearance of the HIE IND last month, we are now looking forward to advancing RLS-0071 into Phase 2 development.”
RLS-0071 is a 15 amino acid peptide that inhibits both humoral inflammation by blocking classical pathway complement activation and cellular inflammation by blocking the neutrophil effectors myeloperoxidase (MPO) and neutrophil extracellular traps (NETs).
The Phase 1 trial was a single ascending dose (SAD) and multiple ascending dose (MAD) study that enrolled 56 healthy subjects of which 42 received intravenous RLS-0071 across seven cohorts in a ratio of 6 active:2 placebo. The maximum SAD dose was 120 mg/kg and the maximum MAD dose was 40 mg/kg every eight hours for nine doses.
RLS-0071 demonstrated an excellent safety profile with no treatment-related or serious adverse events or infusion-related reactions. 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.
