Corbus pushes toward Phase 3 after positive meeting with FDA
- Mass.-based rare disease company Corbus Pharmaceuticals has had the green flag from the Food and Drug Administration to go ahead with a single Phase 3 trial for anabasum (resunab) in diffuse cutaneous systemic sclerosis following its end of Phase 2 meeting with the regulatory body. There was a pre-market jump in stock of over 13% on the news.
- The 52-week trial, planned for fourth quarter 2017, will enroll around 270 adults with systemic sclerosis who will take the endocannabinoid anabasum at 5 mg or 20 mg twice daily, or placebo. Readout is expected in 2019, followed by a submission for approval.
- The primary outcome will be change in skin thickening (modified Rodnan skin score or mRSS); with secondary outcomes of clinical improvement, and improvement in patient-reported disability and lung function.
Corbus Pharmaceuticals' lead drug, anabasum (previously known as resunab or JBT-101), looks set to move smoothly into a Phase 3 trial for diffuse cutaneous systemic sclerosis following the company's end of Phase 2 meeting with the Food and Drug Administration.
"With the conclusion of a successful end-of-Phase 2 meeting, we believe we have a clear path forward to advance the clinical development of anabasum to support an NDA for the treatment of systemic sclerosis," said Barbara White, CMO of Corbus. "We are engaging the European Medicines Agency in similar discussions."
In a topline data analysis of the Phase 2 trial, released last November, there were clear signs of benefit and this led to a stock surge of over 50% back in November 2016.
"Execution of this Phase 3 study for systemic sclerosis is a top priority for Corbus and we believe we have the expertise, as well as organizational and capital resources to successfully execute this clinical program," said Yuval Cohen, CEO of Corbus.
Systemic sclerosis, a chronic autoimmune disease, affects around 90,000 people across the U.S. and Europe. The disease damages the blood vessels and results in fibrosis of the lungs, heart, kidneys, gastrointestinal tract and musculoskeletal system. Anabasum has orphan drug designation in the U.S. and Europe, as well as fast track designation in the U.S. for the treatment of systemic sclerosis. In 2017, Corbus applied for breakthrough designation in the U.S. for the same indication.
There are no approved treatments for systemic sclerosis, but some drugs treat the symptoms and secondary conditions, such as Actelion's Tracleer (bosentan) for peripheral arterial hypertension in systemic sclerosis. Big pharma is getting involved as part of its push into rare diseases. GlaxoSmithKline has a monoclonal antibody targeting oncostatin M, 2330811, in Phase 1; Roche's combination Actemra/RoActemra (tocilizumab) has been studied in a Phase 2 trial; and Merck KGaA is conducting Phase 2 trials with its anti-CD51 monoclonal antibody abituzumab.
- Corbus Pharmaceuticals Statement
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