JanOne has executed a manufacturing agreement with the contract development and manufacturing organization (CDMO) CoreRx for the formulation and manufacturing of TV1001SR, a treatment for Peripheral Artery Disease (PAD). PAD affects over 8.5 million people in the U.S and there are currently no direct treatments for PAD on the market today. Research Market Future (MRFR) values the PAD market at $3.47 billion in the U.S. by 2023.
 
“CoreRx’s extensive clinical development experience and capabilities made them a natural choice for phase 2b formulation and manufacturing,” said Tony Giordano, chief scientific officer, JanOne. “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.”
 
Current PAD treatments only mitigate the effect of symptoms without treating the underlying cause—reduced ischemic tissue blood flow which is a lack of blood flow to the extremities, and often leads to severe pain. As a result, according to a recent Stanford University study, nearly 25% of patients with PAD are at increased risk of high opioid use. TV1001SR treats the underlying cause of PAD and associated pain, therefore potentially eliminating the need to prescribe dangerous opioids.
 
Todd R. Daviau, chief executive office, CoreRx, 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.”
 
Tony Isaac, chief executiveofficer, JanOne, said, “We expect the formulation process of TV1001SR to begin this March and phase 2b clinical trials to begin Q4 2020. We are confident that CoreRX Pharma will help us to safely and efficiently work through clinical trials, and for what we hope will be a future where we obtain FDA approval and full commercialization.”