NIH to Fund Trial of Pill to Treat Lupus

By | March 7, 2016

Testing a new pill as a treatment lupus, an autoimmune disease estimated to affect 1.5 million people in the U.S., is the aim of a mid-stage trials being announced today by Corbus Pharmaceuticals and funded wholly by the federal government.

Norwood-based Corbus (Nasdaq: CRBP) said this morning that the National Institutes of Health will foot the bill for a 100-patient Phase 2 trial of its drug, Resunab, in patients with systemic lupus erythematosus, also called SLE or lupus. The same drug is already in another NIH-funded Phase 2 trial against a rare inflammatory disease called dermatomyositis, and two more mid-stage trials of the same drug are being funded by the company itself, in systemic sclerosis, or scleroderma, and in cystic fibrosis.

The new trial in lupus, however, would be the biggest yet for the drug, which is as yet the only one in Corbus’ pipeline. It was discovered by UMass Medical School professor Sumner Burstein and acquired in 2014 by Corbus, which formed around the potential for the drug in several potential diseases where inflammation or fibrosis is a key aspect. Resunab is a so-called endocannabinoid-mimetic, and works by binding to a specific receptor on immune cells and fibroblasts and causing the production of messenger cells in the body called lipid mediators that slow down the immune system and prevent scarring.

Out of the four diseases in which Resunab is now being tested, lupus is the only one that’s not considered rare. The company has gotten both Orphan Drug and Fast Track designations to help speed development of the drug in scleroderma and cystic fibrosis, and the Phase 2 trials in both of those diseases are expected to have results by the end of this year.

Until 2011, no new drugs to treat lupus had been approved in the U.S. for more than 60 years. Anti-inflammatory drugs are the most common used to treat lupus, which causes fatigue, pain and swelling in the joints and organ damage, but steroids and medications that suppress the immune system are also common.

Benlysta, by GlaxoSmithKline (NYSE: GSK), is an intravenous drug that was approved in 2011 but sales have not been as strong as hoped. GSK is now developing an injectable form of that drug, while AstraZeneca (NYSE: AZN) is working on another IV drug for the disease. An effective pill could potentially provide an easier treatment that both of those.

Source: Boston Business Journal

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