NORFOLK, Va.--(BUSINESS WIRE)--ReAlta Life Sciences (“ReAlta”), Inc., a company addressing life-threatening diseases through harnessing the power of the immune system, today announced that it has received a no objection letter (NOL) from Health Canada to an Amendment of the Company’s Phase 1 clinical trial of RLS-0071 in healthy volunteers. The study design has been modified to add three multiple ascending dose (MAD) cohorts and an additional single ascending high dose (SAD) cohort to the trial.
“The revised trial design amendment will enable us to expeditiously execute the SAD and MAD parts of this Phase 1 clinical trial and obtain important PK-PD, safety and tolerability data that will inform future Phase 2 clinical trial protocols addressing our target indications,” said Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer. “We look forward to providing additional updates on the trial and obtaining data from this study as it progresses and continues to support our other programs.”
Prior to the amendment, the Phase 1 trial was a single ascending dose randomized, double-blind, placebo-controlled, adaptive-design study to evaluate the safety, tolerability, PK and PD of RLS-0071 in healthy subjects.
About ReAlta Life Sciences
ReAlta Life Sciences, Inc. is a clinical stage biotech company dedicated to harnessing the power of the immune system through its EPICC technology platform, comprised of a family of over 160 engineered peptides, to address life-threatening medical needs. The peptide family leverages one billion years of evolution that has enabled the human astrovirus to inhibit components of the innate immune system. This novel class of therapeutics exploits the virus’ dual targeting approach and enables the rebalancing of complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has been granted Orphan Drug Designation by the U.S. Food and Drug Administration and European Medicines Agency for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates. The company launched in 2018, and is located in Norfolk, Virginia. For more information, please visit www.realtalifesciences.com.