Renova Therapeutics Announces Strategic Focus and Roadmap Prioritization for Its Gene Therapies to Treat Heart Failure and Type 2 Diabetes Mellitus

Renova Has Prioritized Two Primary Regulatory Pathways Where It Is Poised to Launch Pivotal Human Trials for Its Promising Gene Therapies to Treat Heart Failure and Type 2 Diabetes Mellitus

CARLSBAD, CA / ACCESSWIRE / May 8, 2024 / Renova Therapeutics, a biotechnology company developing gene therapy-based treatments for cardiovascular and metabolic diseases, announced today that it has focused its development and commercialization efforts for its RT-100 and RT-200 gene therapies on two primary regulatory pathways as key value drivers. Through these efforts, Renova has been awarded Innovation Passports for the UK's Innovative Licensing and Access Pathway (ILAP) program by the MHRA for both RT-100 for heart failure (HF) and RT-200 for type 2 diabetes mellitus (T2DM).

Renova has prioritized two primary pathways where it is poised to launch human trials for its promising therapies: 1) a pivotal RT-100 Phase 2b/3 clinical trial in the United States, and 2) an RT-200 initial human trial in the UK ILAP program.

Pivotal RT-100 Phase 2b/3 Clinical Trials in the U.S.

Renova's AC6 gene therapy for heart failure (RT-100) is Renova's most advanced, having successfully completed a phase 2 clinical trial showing that the approach is promising, safe and effective.^[1] RT-100 has received a Fast Track designation from the FDA. RT-100 is a single-dose gene therapy for heart failure, one of the most prevalent and devastating chronic diseases in the world. According to the NIH, heart failure affects more than 64 million people worldwide^[2] and is the leading cause of death in the United States.^[3] The Company has developed a roadmap for this pathway and is preparing to submit a plan to the FDA for the Phase 2b/3 study. Success in the pivotal phase 2b trial would be a major value-creation event for Renova and would advance the treatment to phase 3 clinical trials.

RT-200 Human Trials in the UK ILAP Program

Renova's urocortin 2 gene therapy (RT-200) has demonstrated promising preclinical results for type 2 diabetes mellitus. Preclinical studies of RT-200 have been published in JCI Insight.^[4] Diabetes is highly prevalent, affecting 537 million people worldwide or about 10% of the world's population.^[5] This number is predicted to rise to 643 million by 2030. Renova was awarded an Innovation Passport by the UK's MHRA through the ILAP program for "RT-200 (AAV8.Ucn2) in the treatment of patients with T2DM with Hemoglobin A1c (HbA1c) ≥.8.0% on metformin, and diet and exercise program" (application ILAP/IP/22/56146/02). The Company has also developed a roadmap for this pathway and is poised to launch the clinical trial upon approval of the trial plan by the MHRA.

Renova participated in the Global Health Day 2023 Radio Interview by the British On Air Media Group (OAMG) with an aim to discuss revolutionary gene therapy in the treatment of chronic and debilitating diseases. The program was broadcast to 124 stations from Sky News Radio, Radio News Hub and BBC Radio to a combined reach of 42 million listeners throughout the UK.

Renova is also poised to launch a trial for RT-100 in the UK upon approval of the plan by the MHRA and plans to file regulatory applications in other countries for its therapies including for RT-200 human trials in the U.S.

According to CEO Dr. Vijay Mahant, "Genetic medicine is a game changer and a life-transforming approach for treating fatal and debilitating diseases such as heart failure. Most pharmacological drugs treat symptoms and not the root cause of the disease. Genetic medicine potentially fills a void where standard-of-care treatments lack effectiveness, long-term use of medications may cause adverse effects or patients may develop resistance. Renova, upon approval of the plans by the regulatory agencies, is poised to conduct pivotal human trials for both of its RT-100 for heart failure and RT-200 for type 2 diabetes therapies. Successful clinical trial outcomes will position Renova to revolutionize the treatment of two of the world's most pervasive and debilitating diseases."

About Renova Therapeutics

Renova Therapeutics is developing definitive, one-time gene therapies to restore the health of people suffering from chronic diseases. The company is focusing on gene therapy treatments for heart failure and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company's lead product candidate, 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 heart failure. The Company's product pipeline also includes a groundbreaking gene therapy in preclinical stage for sufferers of type 2 diabetes. 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.

DISCLOSURE NOTICE: The information contained in this release is as of May 6, 2024. Renova Therapeutics assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Media and Investor Contact:
+1 858.461.1837
info@renovatherapeutics.com

^[1] Hammond and Gao et al., "Intracoronary Gene Transfer of Adenylyl Cyclase 6 in Patients With Heart Failure: A Randomized Clinical Trial," JAMA Cardiol. 2016 May 1;1(2):163-71.

^[2] Shahim B, Kapelios CJ, Savarese G, Lund LH., "Global Public Health Burden of Heart Failure: An Updated Review," Card Fail Rev. 2023 Jul 27;9:e11. doi: 10.15420/cfr.2023.05. PMID: 37547123; PMCID: PMC10398425.

^[3] Kenneth D. Kochanek et al., "Mortality in the United States, 2022," CDC.gov, NCHS Data Brief No. 492, March 2024.

^[4] Gao and Hammond, et al., "One-time injection of AAV8 encoding urocortin 2 provides long-term resolution of insulin resistance," JCI Insight 2016,1(15):e8832.

^[5] IDF Diabetes Atlas website as of June 5, 2022. https://diabetesatlas.org/

Contact Information

Vijay Mahant
CEO
info@renovatherapeutics.com
619-992-3260

SOURCE: Renova Therapeutics

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