Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19
DALLAS, Texas, June 23, 2020 (GLOBE NEWSWIRE) -- Renibus Therapeutics, Inc., a clinical-stage biotechnology company, announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19.
“Obtaining Fast Track designation will be instrumental in expediting the development of RBT-9 for patients with COVID-19, especially those at increased risk of developing complications,” commented Jeff Keyser, RPh, JD, PhD, President and Chief Operating Officer of Renibus Therapeutics. “We are committed to working closely with the FDA in addressing this pandemic that has affected over 2 million people in the US, of which over 150,000 people have died.”
Preclinical studies have shown that RBT-9 protects various organs, including the lung, heart, kidney, and liver. Importantly, RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19.
“RBT-9’s unique attributes of both organ protection and antiviral activity make it an attractive therapeutic for the treatment of COVID-19,” stated Alvaro Guillem, PhD, Chief Execuive Officer of Renibus Therapeutics. “The Phase 2 study of RBT-9 in COVID-19 will be key in determining whether these attributes improve outcomes in vulnerable patients with this infectious disease.”
Site selection is currently underway for this study. For more information please visit ClinicalTrials.gov: NCT04364763.
About Fast Track Designation
The FDA’s Fast Track designation expedites the development of therapeutics that treat serious diseases and fill an unmet need. The FDA works closely with the Company during the development and review process, allowing more frequent communication and faster advancement through the approval process.
About Renibus Therapeutics, Inc.
Renibus Therapeutics is a clinical stage biotechnology company developing novel therapies for kidney diseases. The Company’s portfolio includes RBT-1 for prevention of acute kidney injury, RBT-2 for delaying progression of chronic kidney disease (CKD), RBT-3 for the treatment of iron deficiency anemia, and RBT-9 for pharmacologic stress testing in kidney diseases and COVID-19.
This article contains information regarding our future discovery, development efforts, business strategy, and market opportunities. This information constitutes a forward-looking statement. There are a number of risks and uncertainties that could cause our actual results to differ materially from those indicated by such forward-looking statements. These risks and uncertainties include those inherent in pharmaceutical research, such as adverse results in our drug discovery and clinical development processes, decisions made by the FDA and other regulatory authorities, market conditions, our ability to obtain, maintain and enforce proprietary rights and our ability to obtain any necessary financing to conduct our planned activities.
For more information, please visit the Company’s website at www.renibus.com.
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