JanOne Readies for Clinical GMP Manufacturing Run

JanOne Inc., a company focused on bringing treatments to market for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, together with its manufacturing partner, has successfully completed the formulation of JAN101, its potential treatment for Peripheral Artery Disease (PAD) expected to soon be in Phase 2b trials. In addition, JAN101 is planned for use to treat COVID-19 vascular complications pending approval of the IND submission, expected to be completed in late August 2020.

JAN101 is one of the few promising treatments for vascular conditions using sodium nitrite that showed success in Phase 1 and Phase 2a trials for improving blood flow and vascular function. The company is preparing its IND packages for FDA submission for continued development as a treatment of PAD and to extend JAN101 to potentially mitigate severe organ and tissue damage caused by COVID-19. The successful formulation of JAN101 will allow the company to begin its engineering run and GMP manufacturing for multiple trials expected to begin in early 2021.

"Working with our manufacturing partner, we have been able to successfully produce JAN101, our sustained release formulation and expect our engineering batch to begin immediately," said Dr. Tony Giordano, chief scientific officer at JanOne.  "We believe we will have the initial GMP batch of 250,000 doses by mid-September 2020. This will provide us with enough tablets to carryout our proposed Phase 2b PAD trials and the COVID-19 treatment study IND, which we are confident will gain approval."

The company will now focus on commercial production capability of JAN101 and is currently negotiating to purchase 1,000 kilos of sodium nitrite from a multinational biopharmaceutical company  to support GMP manufacturing batches of more than 20 million doses of JAN101.