JanOne Completes Pre-IND Meeting with FDA on Jan123
Company now has pathway toward formal drug application
LAS VEGAS, April 18, 2023 /PRNewswire/ -- JanOne (Nasdaq: JAN), the biopharmaceutical innovator specializing in non-addicting painkillers and new treatments for the causes of pain, has completed a successful pre-IND meeting with the FDA regarding Jan123. Jan123 is the company's unique oral delivery of low dose naltrexone formulated to treat complex regional pain syndrome, an orphan disease of severe, debilitating impact.
The Pre-IND meeting with the FDA produced a path toward formal drug application. Discussion topics included preclinical toxicology, CMC (Chemistry, Manufacturing and Control), pharmacokinetics, and clinical implementation. The agency's feedback will be used to move Jan123 toward a New Drug Application under a 505-b2 designation.
Dr. Amol Soin, JanOne's Chief Medical Officer, said, "We are very pleased with our interaction with the FDA. We now have a pathway toward generating the data needed for approval of Jan123. Complex Regional Pain Syndrome is a huge unmet medical need, and we believe that Jan123 can help patients who are suffering from this debilitating condition."
Jan123 is a low dose naltrexone drug candidate that is ideally suited to treat complex regional pain syndrome, a rare orphan disease. It is a unique oral biphasic release tablet that has demonstrated ability to facilitate delivery of the medication to obtain maximum therapeutic benefit.
JanOne CEO Tony Isaac noted that Jan123 is one of two late-stage innovative therapies for pain management developed by JanOne. He said, "We consider our work to be a critical component in the nation's multi-front battle against opioid addiction and overdose deaths."
Forward Looking Statements
This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the statements that JAN 101 will treat PAD, that JAN 123 will treat CRPS, the timing of the commencement of further clinical trials, that the FDA will permit approval through a 505(b)(2) pathway for JAN 123, that upon approval JAN 101 will immediately disrupt the PAD market, and other statements, including words such as "continue", "expect", "intend", "will", "hope" "should", "would", "may", "potential" and other similar expressions. Such statements reflect JanOne's current view with respect to future events, are subject to risks and uncertainties, and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by JanOne, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause JanOne's actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others, those detailed in the Company's periodic reports filed with the Securities and Exchange Commission (the "SEC").
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in JanOne's filings with the SEC underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and JanOne does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. JanOne cannot assure that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Individuals are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
About JanOne Inc.
JanOne is a unique Nasdaq-listed company offering innovative, actionable solutions that it believes can help end the opioid crisis. JanOne is dedicated to funding resources toward innovation, technology and education to find a key resolution to the national opioid epidemic, which is one of the deadliest and most widespread in the nation's history. Its drugs in the clinical trial pipeline have shown promise for their innovative targeting of the causes of pain as a strategic option for physicians averse to exposing patients to addictive opioids.
Please visit www.janone.com for additional information.
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SOURCE JanOne Inc.
Released April 18, 2023