JanOne has selected its bottling and labeling partner to support upcoming clinical trials. JanOne is preparing its investigational new drug (IND) application for FDA submission for JAN101 as a potential treatment for vascular complications caused by Covid-19. JAN101 is already planned for use in Phase 2b trials as a treatment for Peripheral Artery Disease (PAD) expected to start in the first quarter of 2021. JanOne's bottling and labeling partner is a world leader in pharmaceutical testing and will work with the company's clinical and manufacturing teams to ensure the integrity of an initial batch of approximately 3,800 active and placebo bottles of JAN101.
JAN101 is a sodium nitrite based compound that has been shown to improve blood flow, restore vascular function, mitigate inflammation and prevent potential tissue damage in major organs based on results from Phase 1 and Phase 2a studies. There is no current treatment on the market today for PAD and, as there is a growing body of evidence that Covid-19 is a vascular disease, JAN101 has the potential to impact millions of lives.
"Having world-class partners is essential to our success and we continue to build our extended team with some of the most innovative and reputable companies in the world," Tony Isaac, JanOne chief executive officer said.
JanOne expects to submit the IND for the treatment of Covid-19 vascular complications in the coming weeks. The company continues to advance plans to scale-up production of JAN101 with GMP manufacturing expected to begin by the middle of September. Combining expert formulation and manufacturing with reliable bottling and labeling capabilities, the company believes it can ensure immediate availability of clinical product for its Phase 2b PAD study and for clinical studies as a treatment for Covid-19 vascular complications, pending submission of the IND application and FDA approval.