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Renova Therapeutics enters into agreement to receive stresscopin investigational new drug file from Janssen
Date:2/6/2017

SAN DIEGO, Calif., Feb. 6, 2017 /PRNewswire-USNewswire/ -- Renova™ Therapeutics, Inc., a biotechnology company developing gene therapy treatments for congestive heart failure and type 2 diabetes, announced today that it has entered into an agreement with Janssen Pharmaceuticals, Inc., whereby the investigational new drug (IND) file for stresscopin – a hormone involved in responses to physiological stress – will be transferred from Janssen, where it was previously under development. Renova Therapeutics plans to advance development of the stresscopin program as RT-400, a peptide infusion treatment for episodes of Acute Decompensated Heart Failure (ADHF).

In the United States, ADHF accounts for approximately half of all heart failure-related causes of hospitalization.1 From 2005 to 2010, the average estimated number of ADHF hospitalizations in the U.S. was 1.76 million.2 Annual mortality following an ADHF hospitalization is about 30%.3

"Obtaining this stresscopin program IND helps propel forward the development of our peptide infusion product candidate, RT-400," said Jack W. Reich, Ph.D., CEO and Co-founder of Renova Therapeutics. "With this data, we hope to see promising results as we initiate pivotal trials."

In addition, Renova Therapeutics holds an exclusive license to the stresscopin peptide from the nonprofit Research Development Foundation.

About Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF) is a severe episode of acute respiratory distress in which a heart failure patient experiences a sudden or gradual onset of the signs of heart failure that requires either initiation or escalation of treatment to relieve symptoms and prevent death. ADHF is caused by severe fluid congestion of the body's organs, especially the lungs, due to the failing heart providing inadequate circulation.

Symptoms of ADHF can include difficulty breathing, waking up from sleep gasping for air, fatigue, swelling of the legs or feet, as well as chest pain and pressure. Most episodes require immediate emergency room visits or hospitalizations for treatment.

Current treatment options for ADHF primarily involve reducing the organ fluid levels with diuretics, delivered intravenously, and stabilizing heart function with vasodilators such as nitroglycerin. Additional treatments can include providing breathing support using a face mask or breathing tube, as well as an ultrafiltration process to remove fluids in people with ADHF associated with kidney failure.

About Renova Therapeutics
Renova Therapeutics is developing definitive, one-time gene therapies and peptide infusion treatments to restore the health of people suffering from chronic diseases. The first indications the company is pursuing are gene therapy treatments for congestive heart failure (CHF) and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company's lead product, RT-100, is a treatment that delivers a therapeutic gene directly to the heart during a routine outpatient procedure and has the potential to increase heart function in millions of patients with CHF. The company's product pipeline also includes a groundbreaking gene therapy in preclinical stage for sufferers of type 2 diabetes, as well as a peptide infusion therapy for the treatment of acute decompensated heart failure. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.

References
1 Chang PP, Chambless LE, Shahar E, et al. Incidence and Survival of Hospitalized Acute Decompensated Heart Failure in Four US Communities (from the Atherosclerosis Risk in Communities Study). The American journal of cardiology. 2014;113(3):504-510. doi:10.1016/j.amjcard.2013.10.032.
2 Agarwal SK, Wruck L, Quibrera M, et al. Temporal Trends in Hospitalization for Acute Decompensated Heart Failure in the United States, 1998–201. Am. J. Epidemiol. 2016; 183(5):462-470.
3 Dhingra A, Garg A, Kaur S, et al. Epidemiology of heart failure with preserved ejection fraction. Curr Heart Fail Rep. 2014; 11(4):354–365.

 

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