Policy & Regulation
JanOne initiates production of JAN101 cGMP batch for Phase 2b PAD trial and potential COVID-19 study
25 September 2020 -

Pain medication company JanOne Inc (Nasdaq:JAN) stated on Thursday that it has begun the production of JAN101 under Current Good Manufacturing Practices (cGMP) for its upcoming Phase 2b trials for treating Peripheral Artery Disease (PAD) as well as a potential treatment for Covid-19 vascular complications following the successful prototype and engineering batches and positive stability data.

The company added that the Phase 2b trial is expected to begin in early 2021. The initial production batch will be 250,000 sustained release tablets and matching placebos. PAD presents a large market opportunity as there currently are no effective treatments for the disease.

According to the company, 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.

Under the company's animal studies, the sodium nitrite promoted blood vessel growth and function, prevents tissue inflammation and necrosis and prevents diabetic nephropathy. Additionally, three human clinical studies showed sodium nitrite significantly reduces pain.

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