Reata Pharmaceuticals Announces the Activation of an Investigational New Drug Application with RTA 408 Ophthalmic Suspension and Commencement of Clinical Programs
IRVING, Texas, December 23, 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 Transplant and Ophthalmology Products to begin clinical study of RTA 408 Ophthalmic Suspension.
RTA 408 Ophthalmic Suspension is an eye drop form of the semi-synthetic oleanane triterpenoid RTA 408 that promotes the resolution of inflammation by activating the anti-oxidative Nrf2 pathway and suppressing the pro-inflammatory NF-kB pathway. Preclinical data show that topical ocular administration of RTA 408 increases the expression of Nrf2 target genes in ocular tissues and reduces ocular inflammation.
Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells and is an important factor promoting corneal endothelial cell loss following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate intraocular pressure and induce cataract formation. In addition, available ophthalmic anti-inflammatory treatments do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a high unmet clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects.
Reata plans to initiate two Phase 2 studies with RTA 408 Ophthalmic Suspension in Spring 2014. The first Phase 2 study will examine the safety and efficacy of RTA 408 Ophthalmic Suspension for the treatment of ocular inflammation and pain following cataract surgery. The second Phase 2 study will examine the safety and efficacy of RTA 408 Ophthalmic Suspension for the prevention of inflammation and endothelial cell loss following ocular surgery.
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.