Preclinical Study of Reata’s RTA 408 Demonstrates Role in Prevention and Treatment of Radiation Dermatitis

IRVING, Texas, April 10, 2014 – A new study in Radiation Research has shown that treatment with RTA 408 Lotion significantly reduces the duration and severity of radiation dermatitis in a mouse model. The study, “Topical application of the synthetic triterpenoid RTA 408 protects mice from radiation-induced dermatitis”, demonstrated a 55% reduction in the duration of moderate to severe radiation dermatitis.

The study also showed that topical treatment of mice with RTA 408 1.0% Lotion reduced the duration and severity of clinically meaningful radiation dermatitis (grade 2 or greater) and was associated with improved microscopic and macroscopic findings. Furthermore, RTA 408 1.0% Lotion markedly reduced epidermal and collagen thickening, prevented dermal necrosis and alleviated skin ulceration. These data were associated with induction of the antioxidant Nrf2 pathway and suppression of the pro-inflammatory NF-kB pathway. Together, these data indicate that RTA 408 represents a promising new therapy for the treatment of radiation dermatitis.

Radiation treatment (RT) uses high-energy gamma radiation to kill cancer cells and is used in about half of cancer patients at some point during their treatment. The energy from gamma radiation leads to a rapid burst in reactive oxygen species (ROS) that damage cellular DNA, proteins, and lipids in the skin. RT typically 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 may cause pain, long-term scaring and fibrosis that can disfigure and limit motion, and it often reduces the patient’s overall quality of life. Also, it may result in a dose-limiting side effect that leads to delays in the course of therapy or failure to complete RT, which can negatively affect treatment outcomes. It is most common in patients with cancers of the breast, head and neck, and prostate.

Dr. Colin Meyer, Chief Medical Officer for Reata noted that, “Patients and physicians have no approved therapies to prevent or treat radiation dermatitis, and available over-the-counter products have not shown reproducible activity in clinical studies. The results of these preclinical studies suggest that RTA 408 Lotion may be an important new tool for physicians to prevent and reduce radiation-associated skin toxicity, which can be painful, disfiguring and lead to treatment interruptions.”

A Phase 1 study to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RTA 408 Lotion was recently completed in healthy volunteers (https://clinicaltrials.gov/ct2/show/study/NCT02029716). Based on the findings in the 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 patients at risk for radiation dermatitis. This study will be conducted in patients receiving radiation therapy for breast cancer and is anticipated to start in June 2014.

The full article can be found at: http://www.rrjournal.org/doi/pdf/10.1667/RR13578.1.

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 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 effects of AIM pharmacology have been documented in more than 250 scientific papers and, due to their anti-inflammatory, cytoprotective and energy metabolism effects, may be relevant to a wide range of diseases.

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Reata Pharmaceuticals, Inc.
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