Reata Pharmaceuticals
Encyclopedia
Reata Pharmaceuticals, Inc. is a biopharmaceutical company based in Irving, Texas
. Founded in 2002, Reata is currently developing oral anti-inflammatory drugs targeting Nrf2, a master regulator of the antioxidant response in humans. Through its control of the body's production of antioxidants, Nrf2 protects against a broad range of inflammation
and oxidative stress
related diseases, including renal disease, cancer
, cardiovascular disease
s, and neurological diseases (eg: multiple sclerosis
, amyotrophic lateral sclerosis
, alzheimer's disease
.
, is the first antioxidant inflammation modulator (AIM) to enter clinical trial
s. The drug has been shown to significantly increase estimated glomerular filtration rate (GFR)
, and improve several other markers of kidney function in patients with chronic kidney disease (CKD). Bardoxolone methyl has been advanced to late-stage, pivotal clinical trials in patients with chronic kidney disease and type 2 diabetes.
Data from Phase 2 clinical studies of bardoxolone methyl have demonstrated that the drug is:
that affects over 26 million Americans. It is a progressive condition that ultimately leads to End Stage Renal Disease (ESRD) and the need for dialysis
or transplant, and is associated with dramatic increase in the risk of cardiovascular disease. Current standard of care can slow the progression of the disease, but no treatments are currently available to stop it. Due to the high prevalence of the condition, and absence of disease modifying therapy, CKD represents an area of significant unmet medical need.
health problems, and aging.
. The agreement provided Kyowa Hakko Kirin with the exclusive rights to develop and commercialize bardoxolone methyl for CKD and related indications in Japan
, China
, Taiwan
, Korea
, and other select Southeast Asia
n countries. In return, Reata is eligible to receive up to $272 million in up-front fees and milestone payments, in addition to escalating double-digit royalties
from sales in the licensed territories.
September 23, 2010 - Abbott
and Reata announced that they entered into a collaboration agreement to develop and commercialize bardoxolone methyl. Under the agreement, Reata granted Abbott exclusive rights to develop and commercialize bardoxolone methyl outside the U.S., excluding Asian markets outlined in the January 7th agreement with Kyowa Hakko Kirin. In exchange, Reata received upfront and near-term cash payments of $450 million for the licensing rights and a minority equity stake in the company. Additionally, Reata will receive milestone payments upon completion of certain development and approval objectives for bardoxolone in the licensed territories.
Irving, Texas
Irving is a city located in the U.S. state of Texas within Dallas County. According to the 2010 U.S. Census, the city population was 216,290. Irving is within the Dallas–Plano–Irving metropolitan division of the Dallas–Fort Worth–Arlington metropolitan area, designated...
. Founded in 2002, Reata is currently developing oral anti-inflammatory drugs targeting Nrf2, a master regulator of the antioxidant response in humans. Through its control of the body's production of antioxidants, Nrf2 protects against a broad range of inflammation
Inflammation
Inflammation is part of the complex biological response of vascular tissues to harmful stimuli, such as pathogens, damaged cells, or irritants. Inflammation is a protective attempt by the organism to remove the injurious stimuli and to initiate the healing process...
and oxidative stress
Oxidative stress
Oxidative stress represents an imbalance between the production and manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage...
related diseases, including renal disease, cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
, cardiovascular disease
Cardiovascular disease
Heart disease or cardiovascular disease are the class of diseases that involve the heart or blood vessels . While the term technically refers to any disease that affects the cardiovascular system , it is usually used to refer to those related to atherosclerosis...
s, and neurological diseases (eg: multiple sclerosis
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
, amyotrophic lateral sclerosis
Amyotrophic lateral sclerosis
Amyotrophic lateral sclerosis , also referred to as Lou Gehrig's disease, is a form of motor neuron disease caused by the degeneration of upper and lower neurons, located in the ventral horn of the spinal cord and the cortical neurons that provide their efferent input...
, alzheimer's disease
Alzheimer's disease
Alzheimer's disease also known in medical literature as Alzheimer disease is the most common form of dementia. There is no cure for the disease, which worsens as it progresses, and eventually leads to death...
.
Bardoxolone Methyl
Reata's lead program, bardoxolone methylBardoxolone methyl
Bardoxolone methyl is an orally-available first-in-class synthetic triterpenoid belonging to the antioxidant inflammation modulator class...
, is the first antioxidant inflammation modulator (AIM) to enter clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s. The drug has been shown to significantly increase estimated glomerular filtration rate (GFR)
Renal function
Renal function, in nephrology, is an indication of the state of the kidney and its role in renal physiology. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney...
, and improve several other markers of kidney function in patients with chronic kidney disease (CKD). Bardoxolone methyl has been advanced to late-stage, pivotal clinical trials in patients with chronic kidney disease and type 2 diabetes.
Data from Phase 2 clinical studies of bardoxolone methyl have demonstrated that the drug is:
- Producing a significant increase in estimated glomerular filtration rate (eGFR), which is consistent in magnitude and in the high degree of patient response.
- Improving CKD stage (ie: from Stage 4 to Stage 3) in the majority of patients.
- Improving multiple additional measures of renal function, such as blood urea nitrogenBlood urea nitrogenThe blood urea nitrogen test is a measure of the amount of nitrogen in the blood in the form of urea, and a measurement of renal function. Urea is a by- product from metabolism of proteins by the liver and is removed from the blood by the kidneys.-Physiology:The liver produces urea in the urea...
(BUN), serum phosphorus, uric acidUric acidUric acid is a heterocyclic compound of carbon, nitrogen, oxygen, and hydrogen with the formula C5H4N4O3. It forms ions and salts known as urates and acid urates such as ammonium acid urate. Uric acid is created when the body breaks down purine nucleotides. High blood concentrations of uric acid...
, and magnesiumMagnesiumMagnesium is a chemical element with the symbol Mg, atomic number 12, and common oxidation number +2. It is an alkaline earth metal and the eighth most abundant element in the Earth's crust and ninth in the known universe as a whole...
. - Well tolerated.
- Suitable for once-daily dosing.
- Targeting Nrf2 pathway and supporting an anti-inflammatory mechanism.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a common complication of diabetes and hypertensionHypertension
Hypertension or high blood pressure is a cardiac chronic medical condition in which the systemic arterial blood pressure is elevated. What that means is that the heart is having to work harder than it should to pump the blood around the body. Blood pressure involves two measurements, systolic and...
that affects over 26 million Americans. It is a progressive condition that ultimately leads to End Stage Renal Disease (ESRD) and the need for dialysis
Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure...
or transplant, and is associated with dramatic increase in the risk of cardiovascular disease. Current standard of care can slow the progression of the disease, but no treatments are currently available to stop it. Due to the high prevalence of the condition, and absence of disease modifying therapy, CKD represents an area of significant unmet medical need.
Pipeline
Reata is developing a series of other antioxidant inflammation modulators (AIMs) with activity against a variety of intractable diseases. These unique drugs help to restore the balance between pro-oxidant and antioxidant signaling molecules within the cell by mimicking the body's own natural regulators of inflammation. By increasing the production of enzymes that maintain the antioxidant buffering system within the cell, they prevent harmful inflammation and the associated oxidative stress and organ/DNA damage caused by high concentrations of oxygen and nitrogen radicals. Also, by activating enzymes that maintain the antioxidant buffering system, they increase the body's ability to protect against tissue damage from toxic insults, chronicChronic (medicine)
A chronic disease is a disease or other human health condition that is persistent or long-lasting in nature. The term chronic is usually applied when the course of the disease lasts for more than three months. Common chronic diseases include asthma, cancer, diabetes and HIV/AIDS.In medicine, the...
health problems, and aging.
Partnerships
January 7, 2010 - Reata announced that they entered into a licensing agreement with Kyowa Hakko Kirin Co., LtdKyowa Hakko Kirin
is a Japanese pharmaceutical company, among the 50 largest in the world by revenue. The company is a member of the Nikkei 225.-External links:*...
. The agreement provided Kyowa Hakko Kirin with the exclusive rights to develop and commercialize bardoxolone methyl for CKD and related indications in Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
, China
China
Chinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...
, Taiwan
Taiwan
Taiwan , also known, especially in the past, as Formosa , is the largest island of the same-named island group of East Asia in the western Pacific Ocean and located off the southeastern coast of mainland China. The island forms over 99% of the current territory of the Republic of China following...
, Korea
Korea
Korea ) is an East Asian geographic region that is currently divided into two separate sovereign states — North Korea and South Korea. Located on the Korean Peninsula, Korea is bordered by the People's Republic of China to the northwest, Russia to the northeast, and is separated from Japan to the...
, and other select Southeast Asia
Southeast Asia
Southeast Asia, South-East Asia, South East Asia or Southeastern Asia is a subregion of Asia, consisting of the countries that are geographically south of China, east of India, west of New Guinea and north of Australia. The region lies on the intersection of geological plates, with heavy seismic...
n countries. In return, Reata is eligible to receive up to $272 million in up-front fees and milestone payments, in addition to escalating double-digit royalties
Royalties
Royalties are usage-based payments made by one party to another for the right to ongoing use of an asset, sometimes an intellectual property...
from sales in the licensed territories.
September 23, 2010 - Abbott
Abbott Laboratories
Abbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....
and Reata announced that they entered into a collaboration agreement to develop and commercialize bardoxolone methyl. Under the agreement, Reata granted Abbott exclusive rights to develop and commercialize bardoxolone methyl outside the U.S., excluding Asian markets outlined in the January 7th agreement with Kyowa Hakko Kirin. In exchange, Reata received upfront and near-term cash payments of $450 million for the licensing rights and a minority equity stake in the company. Additionally, Reata will receive milestone payments upon completion of certain development and approval objectives for bardoxolone in the licensed territories.