JanOne has started production of JAN101 under Current Good Manufacturing Practices (cGMP) for the company's anticipated Phase 2b trials to treat Peripheral Artery Disease (PAD) and as a potential treatment for Covid-19 vascular complications.
This development follows the successful completion of the JAN101 prototype and engineering batches and positive stability data. The initial production batch will be 250,000 sustained release tablets and matching placebos. The Phase 2b trial is expected to begin in early 2021. PAD presents a large market opportunity as there currently are no effective treatments for the disease.
"The initiation of this batch is a major milestone for the Company, as it demonstrates that we now have the ability to economically scale up production of JAN101," said Tony Isaac, President and Chief Executive Officer of JanOne. "This cGMP batch will help set the stage for our anticipated Phase 2b PAD trial, as well as the exploration of JAN101 as a treatment for vascular complications caused by Covid-19, with additional product available for collaborations with independent investigators on other indications."
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JAN101 is a patented sustained release form of sodium nitrite aimed at improving vascular function, reducing neuropathic pain and other conditions resulting from poor blood flow. It is highly selective, acting only in damaged tissue. In animal studies, sodium nitrite has been shown to promote blood vessel growth and function, prevents tissue inflammation and necrosis, and prevents diabetic nephropathy, a leading cause of death in diabetics. Additionally, three human clinical studies have found that sodium nitrite significantly reduces pain.