ReAlta Life Sciences Announces U.S. FDA Clearance of First Investigational New Drug Application for RLS-0071

Phase 1 Trial for the Treatment of Patients with Acute Lung Injury Due to COVID 19 Anticipated to Begin in Third Quarter of 2020

NORFOLK, Va.--(BUSINESS WIRE)--ReAlta Life Sciences, Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for RLS-0071 for the treatment of acute lung injury secondary to COVID-19. RLS-0071, the company’s lead product candidate, is a proprietary engineered peptide with a dual targeting mechanism designed to inhibit complement and anti-inflammatory immune responses by directly interacting with immune cells to modulate their activation and subsequently reduce excessive inflammation. RLS-0071 is initially being developed for the treatment of acute lung injury in COVID-19 and a rare pediatric condition, hypoxic ischemic encephalopathy (HIE).

In COVID-19 patients, the viral infection can lead to uncontrolled inflammation and acute lung injury, characterized by severe and quickly progressing lung damage. In preclinical disease models, RLS-0071 demonstrated an ability to modulate complement, neutrophil and cytokine activation and reduce the key inflammatory pathways that contribute to acute lung injury.

“The impact of COVID-19 on patients can be extreme, including life-threatening pulmonary conditions, including acute lung injury,” said Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer. “At ReAlta, our goal is to harness the power of the immune system to treat a range of underserved conditions. Based on research studies, RLS-0071 may be able to address the damaging inflammatory cascade that arises in COVID-19 patients with acute lung injury. With the clearance of this IND, we are eager to begin clinical development with RLS-0071 and aid in the industry’s efforts to treat patients suffering from the global pandemic.”

ReAlta expects to begin a Phase 1 randomized, double-blind, placebo-controlled clinical trial of RLS-0071 in adult patients with pneumonia and early respiratory failure in the third quarter of 2020. The trial will be conducted at multiple U.S. sites., and additional details will be announced upon study initiation.

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 PIC1 technology platform, comprised of a family of over 160 engineered peptides, to address life-threatening medical needs. To support its vision, ReAlta has developed a novel class of therapeutics with a dual targeting approach designed to rebalance 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.