Renova Therapeutics, a biotech company focused on creating gene therapy solutions for cardiovascular and metabolic conditions, has disclosed its strategic plans to expand the therapeutic use of its gene therapies to address additional severe health issues.

The company is progressing with its two primary therapies and is set to commence a phase 2b/3 clinical trial for heart failure (HF) and a first-in-human trial for type 2 diabetes (T2DM), pending regulatory approvals.

Renova’s Ucn2 gene therapy has shown potential in preclinical studies for treating type 2 diabetes and may also be beneficial for type 1 diabetes, non-alcoholic fatty liver disease (NAFLD), hypertension, and heart failure.

In terms of NAFLD, a leading cause of liver failure in the U.S., studies have shown that Ucn2 gene transfer significantly reduces fatty infiltration in the liver six to eight weeks after a single intravenous administration.

For type 1 diabetes, research indicates that a single intravenous injection of AAV8.Ucn2 results in significant improvements in glucose control, reduced retinopathy, and a decrease in mortality rates from 94% to 18% (p<.0001). Other studies have validated the effectiveness of Ucn2 gene therapy in managing heart failure with both reduced and preserved ejection fractions.

Renova has secured an NIH STTR Award to investigate the application of Ucn2 gene therapy for type 1 diabetes and associated left ventricular dysfunction.

Hypertension, a major risk factor for heart failure, stroke, and kidney failure, affects approximately 122 million adults in the U.S. Renova is researching the potential of Ucn2 gene therapy to manage this condition, addressing the ongoing challenges in its treatment.

Renova possesses worldwide exclusive licenses for essential patents related to the composition and delivery methods of its therapies, along with clinical data. The company intends to further develop its intellectual property, acquire strategic IP, and utilize market exclusivity for its gene therapies as recognized by regulatory authorities.

“While there are many treatments available for diabetes, a significant number of patients still struggle with managing blood sugar levels and experiencing complications. Gene therapy offers a promising new approach to alleviating these challenges,” stated Dr. David Horwitz, a member of Renova’s Scientific Advisory Board. Dr. Horwitz, who has held roles as the Global Chief Medical Officer at the Johnson & Johnson Diabetes Institute and a member of the FDA advisory panel in clinical chemistry and toxicology, brings valuable expertise to Renova’s initiatives.

“Dr. Horwitz’s extensive background in healthcare and metabolic diseases greatly enhances our ability to develop our therapies and improve patient outcomes globally,” said Dr. Vijay Mahant, CEO of Renova.

 

Source: newswire.com

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