IRVING, Texas, December 16, 2013 – Reata Pharmaceuticals, Inc., announced today the activation of an Investigational New Drug Application (IND) filed with the U.S. Food and Drug Administration (FDA) Division of Dermatology and Dental Products for the clinical study of RTA 408 Lotion.
RTA 408 Lotion is a topical formulation of RTA 408, a semi-synthetic oleanane triterpenoid that promotes the resolution of inflammation by activating the anti-oxidative Nrf2 pathway and suppressing the pro-inflammatory NF-kB pathway. In preclinical studies, topical application of RTA 408 Lotion was highly protective of the skin in rodent models of radiation-induced dermatitis. The protection against radiation-induced dermatitis is consistent with data showing that topical dermal administration of RTA 408 activates the Nrf2 pathway and increases expression of Nrf2 target genes in the dermis and epidermis of animals and ex vivo human skin explants.
Reata plans to initiate a Phase 1 program to study the safety, tolerability, pharmacodynamics, and pharmacokinetics of RTA 408 Lotion in healthy volunteers before the end of the year, and results should be available in Spring of 2014. If results of the Phase 1 study are as expected, Reata plans to then initiate a Phase 2 program to study the efficacy, safety, pharmacokinetics, and pharmacodynamics of RTA 408 Lotion in the treatment of patients at risk for radiation 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.