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.
Company now has pathway toward formal drug
application
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.
Media Contact
Investor Relations
IR@janone.com
1-800-400-2247
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SOURCE JanOne Inc.