The more you know, the better you can treat PAD.
Frequently Asked Questions?
Frequently Asked Questions, What is JAN101? What is it indicated for?
JAN101 is a twice-daily orally-dosed slow-release formulation of the FDA-approved compound, therapeutic sodium nitrite. Results from Phase 2a clinical trials support the use of sodium nitrite for the treatment and prevention of peripheral artery disease. An unexpected outcome of the studies was that some patients reported a significant reduction in PAD-associated pain. This led to our developing clinical protocols for PAD and PAD-associated pain for Phase 2b trials, expected to begin in second half of 2020.
What is peripheral artery disease?
Peripheral artery disease, or PAD, is a chronic disorder that reduces blood flow to the extremities, resulting in severe pain, limited mobility, and in some cases, death.
The primary cause is the buildup of fatty acids in the blood vessels, or atherosclerosis, that leads to the formation of plaques in the vessels, which in turn block or weaken the vessel walls, ultimately resulting in reduced blood flow. Blood clots, diabetes, inflammation, infection and injury can also lead to PAD.
If left untreated, PAD, will lead to critical limb ischemia (CLI), or a blockage of arteries in the lower extremities. This may lead to amputation of the affected limb.
In the United States, estimates are that PAD affects nearly 9 million people with an annual cost of care at $10+billion annually.
Why is this drug important? How is it different?
JAN101 promotes recovery in tissues damaged as a result of PAD by restoring blood flow. When given in an extended-release formulation versus the single dose methodologies currently in use for other indications, JAN101 was shown to restore blood flow, leading to the development of new blood cells (angiogenesis), and new collateral blood vessels (arteriogenesis).
In initial research studies the drug effectively restored ischemic tissue blood flow (blood supply to the tissues), and was effective in a wide range of pathologies involving alterations of angiogenesis including diabetes, wound healing and tissue necrosis or death of tissues that cannot be restored.
In clinical trials, JAN101 was shown to not only restore blood flow to affected tissues, patients in the study reported a reduction in pain as a result of the improved circulation.
With further testing, JAN101 may be shown to be a non-addictive alternative to chronic opioid therapy for patients with PAD-related pain.