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Our Science

We explore the frontiers of science to further human health.

Our Technologies

Reata has active clinical, preclinical, and internal discovery programs in many significant disease areas. We focus on molecular pathways that regulate cellular metabolism, inflammation, and the response to cellular stress in serious and life-threatening diseases that have limited or no approved therapies.

Nrf2 Activators

nrf2 2flu

©Reata Pharmaceuticals, Inc.
Kelch domain of Keap1
PDB Code 2FLU

Nrf2 is a transcription factor that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Bardoxolone methyl and omaveloxolone are in development for the treatment of several forms of chronic kidney disease and a severe neurologic disorder called Friedreich’s ataxia, respectively.

HSP90 Modulators

hsp90

©Reata Pharmaceuticals, Inc.
Middle segment of HSP90
PDB Code 1USV

We are developing a novel class of molecules that target pathways involved in the cellular stress response. Our lead product candidate, RTA 901, and related analogs have shown promising effects in animal models of neurological disease. RTA 901 is in development for Diabetic Peripheral Neuropathic Pain.

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Our Pipeline

Reata’s development programs have created a robust pipeline of drug candidates for the treatment of serious, life-threatening diseases.

Discovery
Preclinical
Phase 1
Phase 2
Pivotal
NDA*
Chronic Kidney Disease
CKD Caused by Alport Syndrome | Bardoxolone* Alport Syndrome
Bardoxolone

The Phase 3 CARDINAL study was an international, multi-center, double-blind, placebo-controlled, randomized clinical trial that enrolled 157 patients with CKD caused by Alport syndrome at approximately 50 study sites in the United States, Europe, Japan, and Australia. Patients were randomized 1:1 to bardoxolone or placebo. The primary endpoint for Year 2 of the study was the change from baseline in eGFR after 100 weeks of treatment (end-of-treatment). The key secondary endpoint for Year 2 of the study was the change from baseline in eGFR at Week 104 (four weeks after last dose in second year of treatment).

Follow the links to:

Autosomal Dominant Polycystic Kidney Disease | Bardoxolone ADPKD
Bardoxolone

FALCON is an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone in patients with ADPKD randomized one-to-one to bardoxolone or placebo. FALCON will enroll 550 patients in a broad range of ages, 18 to 70 years old, with an estimated glomerular filtration rate (eGFR) between 30 to 90 mL/min/1.73 m2. The key primary endpoint is the off-treatment eGFR change from baseline versus placebo at Week 52, which represents 48 weeks of treatment followed by a four-week withdrawal period. At Week 52, patients resume treatment for a second 48-week period to Week 100 followed by a second four-week withdrawal period to Week 104. The secondary endpoint is the off-treatment eGFR change from baseline versus placebo at Week 104.

We expect to complete enrolling the FALCON study by the end of 2021.

Follow the links to:

IgA Nephropathy | Bardoxolone IgA Nephropathy
Bardoxolone

PHOENIX was an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of bardoxolone in patients with rare forms of CKD, including patients with autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy (IgAN), type 1 diabetic CKD (T1D CKD), and focal segmental glomerulosclerosis (FSGS). The primary endpoint was increase in eGFR from baseline at 12 weeks.

Follow the links to:

Type 1 Diabetes | Bardoxolone Type 1 Diabetes
Bardoxolone

PHOENIX was an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of bardoxolone in patients with rare forms of CKD, including patients with autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy (IgAN), type 1 diabetic CKD (T1D CKD), and focal segmental glomerulosclerosis (FSGS). The primary endpoint was increase in eGFR from baseline at 12 weeks.

Follow the links to:

Focal Segmental Glomerulosclerosis | Bardoxolone FSGS
Bardoxolone

PHOENIX was an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of bardoxolone in patients with rare forms of CKD, including patients with autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy (IgAN), type 1 diabetic CKD (T1D CKD), and focal segmental glomerulosclerosis (FSGS). The primary endpoint was increase in eGFR from baseline at 12 weeks.

Follow the links to:

At Risk of Rapid Progression | Bardoxolone Rapid Progression
Bardoxolone

MERLIN is a proof of concept, multi-center, double-blind, placebo-controlled, Phase 2 trial to evaluate the safety and efficacy of bardoxolone (bardoxolone) in patient populations with CKD at meaningful risk of progression to end-stage kidney disease. Multiple etiologies of CKD will be studied, including patient populations we have studied before (IgA nephropathy, type 1 diabetic CKD, type 2 diabetic CKD, and focal segmental glomerulosclerosis) and those we have not studied, such as hypertensive CKD and others.

MERLIN is anticipated to enroll approximately 70 patients with eGFR between 20 and 60 mL/min/1.73 m2, and patients must meet at least one of the rapid progression criteria (see clinicaltrials.gov link below). The primary objective is to assess change in eGFR from baseline at week 12, and the secondary objective is to characterize change in eGFR from baseline by CKD etiology at Week 12. The exploratory efficacy objective is to characterize change in eGFR from baseline during a 5-week drug treatment withdrawal period. The results from MERLIN may provide us proof of concept to potentially proceed to a larger Phase 3 study with similar eligibility criteria and a longer treatment duration.

Enrollment began in February 2021, and we expect data in the second half of 2021.

Follow the links to:

Neurology
Friedreich's Ataxia | Omaveloxolone** Friedreich's Ataxia
Omaveloxolone

The Phase 2 MOXIe Part 2 study was an international, multi-center, double-blind, placebo-controlled, randomized registrational study, that enrolled 103 patients with Friedreich’s ataxia (FA) at 11 study sites in the United States, Europe, and Australia and is the largest global, interventional study ever conducted in FA. Patients were randomized 1:1 to 150 mg of omaveloxolone or placebo. The primary endpoint was change in the modified Friedreich’s Ataxia Rating Scale (mFARS) relative to placebo after 48 weeks of treatment.

Follow the links to:

Diabetic Peripheral Neuropathic Pain | RTA 901 DPNP
RTA 901

We completed a Phase 1 SAD/MAD trial of oral, once-daily RTA 901 in healthy adult volunteers to evaluate the safety, tolerability, and PK profile. No safety or tolerability concerns were reported, and we observed an acceptable PK profile.

Follow the links to:

Bardoxolone = Bardoxolone methyl; *NDA accepted for filing by the FDA; **Subject to discussion with regulatory authorities

Bardoxolone methyl, omaveloxolone, and RTA 901 are investigational drugs. Safety and efficacy have not been established by any agency.

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