Nrf2 drugs in development
N.B this page will be updated with relevant pharmaceutical Nrf2 news as it comes out.
September 23, 2013
Biogen Idec (NASDAQ: BIIB) will present 58 data sets from the company’s multiple sclerosis (MS) clinical portfolio of approved and investigational products at the 29(th) Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, October 2-5.
TECFIDERA is an oral therapy for relapsing forms of MS, including relapsing-remitting MS, the most common form of MS. TECFIDERA is currently approved in the United States, Canada and Australia, and is under review by regulatory authorities in the European Union.
TECFIDERA has been proven to reduce MS relapses, progression of disability and MS brain lesions, while demonstrating a favourable safety and tolerability profile. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and gastrointestinal (GI) events. Other side effects included a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued. The efficacy and safety of TECFIDERA has been studied in a large, global clinical program with more than 3,600 MS patients, which includes an ongoing long-term extension study. It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
July 23, 2013
A class of antioxidants called synthetic triterpenoids blocked development of Parkinson’s in an animal model that develops the disease in a handful of days, said Dr. Bobby Thomas, neuroscientist at the Medical College of Georgia at Georgia Health Sciences University and corresponding author of the study in the journal Antioxidants & Redox Signaling.
Thomas and his colleagues were able to block the death of dopamine-producing brain cells that occurs in Parkinson’s by using the drugs to bolster Nrf2, a natural antioxidant and inflammation fighter.
Their preliminary evidence indicates the synthetic triterpenoids also increase Nrf2 activity in astrocytes, a brain cell type which nourishes neurons and hauls off some of their garbage. The drugs didn’t protect brain cells in an animal where the Nrf2 gene was deleted, more proof that that Nrf2 is the drugs’ target.
Apr 11, 2013
Biogen has a new Multiple Sclerosis drug approved which works by targeting the Nrf2 pathway. At $55,000/year it’s not cheap and out of range of the average person if their health insurance won’t cover it.
Biogen scored a big win with the Tecfidera approval on March 26, which classified the drug as first-line treatment for the disease, meaning it can be used for newly diagnosed patients.
Tecfidera is different than most MS treatments in that it activates Nrf2 — a powerful protein that basically sleeps inside every cell in the human body. When awakened (or activated), Nrf2 bonds to the DNA within a target cell and jump-starts the body’s own defenses against inflammation by helping shut down unstable chains of cell-damaging free radicals. Research suggests that Tecfidera also can boost the central nervous system’s ability to reduce other processes associated with MS.
The drug, which costs nearly $55,000 a year per patient, could net Biogen more than $3 billion in annual sales.
Biogen has been doing clinical trials on a drug called BG-12 which could be their next billion-dollar hit. It works by targeting the damaging effects of oxidative stress on neurons, and it improves glutathione levels in patients. This compound has had years of testing, millions of dollars invested, and multiple rounds of clinical trials.
Abbott has payed US$400 million to Reata Pharmaceuticals as part of an agreement to co-develop and bring to market second-generation oral antioxidant inflammation modulators (AIMs) which function as NRF2 activators to reduce oxidative stress. These drugs could potentially be used to help treat cardiovascular disease, neurodegenerative disorders and immunology.
Colby Pharmaceutical Co. has acquired Othera Pharmaceuticals, a Conshohocken, Pa., biopharmaceutical company. Othera is focused on developing treatments for Nrf-2-regulated diseases characterized by oxidative stress injury. David Zarling, CEO of Colby, said in a statement that his company was attracted to Othera’s portfolio of “patented small molecules with strong data demonstrating their ability to target oxidative stress related diseases, including cancer and other conditions caused by chronic inflammation.”
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