IRVING, Texas, April 24, 2014 – Reata has completed a Phase 1 study to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RTA 408 Lotion in healthy volunteers.
RTA 408 is a novel oleanane triterpenoid that activates Nrf2 and inhibits NF-κB, thereby inducing an anti-inflammatory and antioxidant phenotype. Due to the broad potential of RTA 408 to treat many dermatological conditions associated with increased inflammation, Reata developed a lotion formulation and conducted a first-in-human Phase 1 study to assess safety, pharmacokinetics, and pharmacodynamic activity.
In the dose-ranging portion of the study, vehicle and three concentrations of RTA 408 Lotion (0.5%, 1%, and 3%) were applied twice daily for two weeks. RTA 408 Lotion produced the desired pharmacodynamic response in the skin necessary for pharmacological activity and efficacy. In subsequent cohorts, RTA 408 Lotion (3%) was applied to larger surface areas for up to 28 days, and the pharmacologic response in the skin was further increased and sustained through 28 days.
Results from this Phase 1 study demonstrate that RTA 408 Lotion has a favorable safety, tolerability, pharmacokinetic, and pharmacodynamic profile that should allow for further examination in future clinical trials. Dr. Colin Meyer, Chief Medical Officer for Reata, noted that “We are very encouraged by the favorable results from this Phase 1 study of our lotion formulation of RTA 408. The data from this study strongly support continued development of RTA 408 Lotion.”
Based on the findings in this Phase 1 study, Reata plans to initiate a Phase 2 study to test the efficacy, safety, pharmacokinetics and pharmacodynamics of RTA 408 Lotion in the treatment of breast cancer patients receiving radiation therapy (RT) who are at risk for radiation dermatitis. RT destroys cellular structures in the skin leading to ulceration, necrosis, and fibrosis of skin tissues. Radiation dermatitis usually manifests within one to four weeks after initiation of RT and persists until two to four weeks after completion of RT. Radiation dermatitis causes pain, long-term scaring and fibrosis that can disfigure and limit motion, and reduces the patient’s overall quality of life. Also, it may result in a dose-limiting side effect of RT that leads to delays in the course of therapy or failure to complete RT, which can negatively affect treatment outcomes. There are currently no approved agents for the prevention of radiation-induced dermatitis.
About Reata Pharmaceuticals, Inc.
Reata Pharmaceuticals, Inc. is a privately held company aiming to translate innovative research into breakthrough medicines for difficult diseases that have significant unmet needs. Reata is the leader in developing a novel class of drugs with potent transcription-regulating activity called antioxidant inflammation modulators (AIMs). AIMs activate Nrf2, promoting the production of numerous antioxidant, detoxification, and anti-inflammatory genes, and inhibit NF-κB, a transcription factor that regulates many pro-inflammatory proteins. The pharmacology of the AIMs mimics that of endogenous prostaglandin metabolites that are responsible for the orchestrated resolution of inflammation. The anti-inflammatory, cytoprotective and energy metabolism effects of AIM pharmacology have been documented in more than 250 scientific papers and are potentially relevant to a wide range of diseases.
Reata Pharmaceuticals, Inc.