News

USA FDA Grants Fast Track Designation to ReAlta Life Sciences’ Lead Compound RLS-0071

ReAlta Life Sciences (“ReAlta”), Inc., a clinical stage, rare disease company dedicated to harnessing the power of the immune system to address life threatening diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to RLS-0071 for the treatment of hypoxic ischemic encephalopathy (HIE). RLS-0071 is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide.

“Based on our compelling preclinical data and the strong safety profile established in our Phase 1 Healthy Volunteers study, we believe we have an opportunity to radically change the way we treat HIE and other rare diseases,” said Ulrich Thienel, CEO of ReAlta. “The designation of Fast Track is a testament to the unmet need in HIE and will support a closer collaboration with FDA on our clinical development plan and work to earlier drug approval and access by patients.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Benefits of this designation include more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as more frequent written communication to discuss aspects such as the design of the proposed clinical trials and use of biomarkers. A drug that receives Fast Track designation may also be eligible for Accelerated Approval and Priority Review.

HIE, also known as birth asphyxia, is a rare disease that affects newborns suffering an abrupt, unexpected loss of oxygenation due to placental rupture, umbilical cord problems, or other factors. The initial loss of oxygen and the dysregulated inflammatory process that follows causes damage to the brain and other organs. This acute disease often results in death or moderate-to-severe cognitive and physical disability, with life-long impacts on both the newborn and the newborn’s family.

RLS-0071 is a 15 amino acid peptide that both inhibits humoral inflammation by blocking classical pathway complement activation and cellular inflammation by blocking the neutrophil effectors myeloperoxidase (MPO) and neutrophil extracellular traps (NETs).

Recent News

09/22/2023

State public health laboratory, Henrico County Schools launch pilot program to promote life science career

More than 50 Henrico County high school students and teachers joined scientists from Virginia’s public health and environmental laboratory Wednesday to kick off an innovative program that brings together private and government scientists and experts, business and nonprofit leaders, and public schools to explore ways to create a pipeline of talent to fuel Virginia’s growing

09/21/2023

Climate Tech Startup ThermaGEL Innovations’ Breakthrough Aerogels Join the Challenge to Save Half-Gigaton of C02 Emissions Each Year

In the fight against climate change, properly insulating homes and buildings can significantly raise energy efficiency and indoor air quality while lowering carbon dioxide emissions. A startup company, spun out of research at Virginia Commonwealth University, is commercializing what it calls a breakthrough in low-cost insulation materials. ThermaGEL Innovations has developed insulation material using aerogels,

09/20/2023

Charlottesville healthy sugar innovator Bonumose raises $2M

Bonumose Inc., a Charlottesville startup specializing in table sugar alternatives, has raised $2 million toward a $10 million funding round after German flavor and fragrances producer Symrise AG signed a minority investment agreement with the company. “The strategic investment from Symrise is part of a larger funding round that will be used for increasing sales,