RT-200 (Urocortin 2 gene transfer)
RT-200 for type 2 diabetes is a first-of-its-kind IV-injected, single-dose investigational gene transfer of peptides with beneficial paracrine activity is designed to provide substantially improved, sustained outcomes in type 2 diabetes patients by normalizing blood glucose, supported by:
- Increased insulin sensitivity and glucose disposal
- Long-lasting resolution of abnormal glucose homeostasis
- Reduction in fatty infiltration of the liver
RT-200 possesses advantages over current diabetes medications: It is insulin-sensitizing, circumvents the need for daily insulin injections, and reduces weight gain and fatty infiltration of the liver.
RT-200 delivers a therapeutic gene – urocortin 2 – using a single intravenous injection, a common procedure that can be administered by medical professionals in any doctor’s office. The technology has been shown to safely and efficiently deliver the urocortin 2 gene therapy in mice. The human gene encoding urocortin 2 is delivered via an adeno-associated virus (AAV) that is able to enter cells – primarily in the liver – but cannot reproduce itself.
Preclinical data indicate that gene transfer, via a one-time intravenous injection of a viral vector encoding urocortin 2, increases insulin sensitivity and glucose disposal, provides long-lasting resolution of abnormal glucose homeostasis, and reduces fatty infiltration of the liver in two mouse models of insulin resistance. These findings indicate a promising strategy for treating clinical type 2 diabetes and unlock the potential for treatment of other cardiovascular and metabolic diseases, including nonalcoholic fatty liver disease. In similar protocols in which mice were dosed initially prior to being fed a high-fat diet, treated mice did not develop type 2 diabetes– signaling a potential for a preventive therapy.
Renova Therapeutics plans to submit an Investigational New Drug application with the U.S. Food and Drug Administration in which patients with type 2 diabetes are enrolled to receive RT-200 in well-controlled and safely conducted clinical trials. In addition, the company is pursuing multiple regulatory pathways internationally.
Renova Therapeutics is studying RT-200 for the treatment of type 2 diabetes, the first indication for which we will be seeking approval.
INTERNATIONAL REGULATORY STATUS
The British Medicines & Healthcare products Regulatory Agency (MHRA) on December 20, 2022, awarded Renova Therapeutics the Innovation Passport (IP) 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.