JanOne has signed a manufacturing agreement with cGMP contract manufacturer CoreRx for the clinical formulation and manufacturing of its lead drug candidate TV1001SR, a potential treatment for peripheral artery disease (PAD).
More than 8.5 million people in the US are affected by peripheral artery disease for which currently there are no direct treatments available.
Tony Giordano – JanOne chief scientific officer said: “CoreRx’s extensive clinical development experience and capabilities made them a natural choice for phase 2b formulation and manufacturing.
“As we finalize our clinical protocols for FDA submission and enter the next phase of trials for what we believe could be an effective PAD treatment, CoreRx is a proven partner with exceptional quality controls.”
According to JanOne, current treatments for peripheral artery disease only mitigate the effect of symptoms without curing the underlying cause, which is reduced ischemic tissue blood flow, which is a lack of blood flow to the extremities, which usually results in severe pain.
JanOne claims that TV1001SR has been designed to treat the underlying cause of peripheral artery disease and associated pain, thereby potentially removing the need to prescribe dangerous opioids.
Todd R. Daviau – CoreRx President and CEO said: “JanOne presents a unique opportunity for our company to have an impact on patients beyond the disease itself with the potential pain relieving qualities of its PAD formulation.
“We share JanOne’s vision for bringing to market a drug that can treat the underlying cause of PAD and that the company believes also has the potential to reduce the need for opioid prescriptions to treat associated pain. This emboldens our commitment to help make TV1001SR a success.”
Established in 2006. CoreRx operates more than 150,000 square feet of cGMP lab and manufacturing facilities, which includes half a dozen formulation suites, 18 manufacturing suites, and a couple of analytical labs.
CoreRx is expected to begin the formulation process of TV1001SR in March with JanOne scheduling its phase 2b clinical trials in the fourth quarter of 2020.