JanOne management is encouraged regarding recent discussions on the potential phase 2b Trial endpoints and possible regulatory pathways for JAN101 as a treatment for peripheral arterial disease (PAD)
LAS VEGAS, September 28, 2021 / PRNewswire / – JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain, alongside its continued focus on developing drugs with non-addictive pain relief properties – announced today that it is revising its development strategy based on recent communications with the United States Food and Drug Administration (FDA) for its upcoming clinical trial of the leading drug candidate JAN101 as a treatment for peripheral artery disease (PAD). JanOne previously submitted data from Phase 1 and Phase 2a studies of the product showing improved vascular function and reduced pain, which were incorporated into its phase 2b primary and secondary protocols and endpoints. The FDA reviewed the data and provided recommendations and comments on the planned clinical trial for JanOne.
“JanOne is grateful for the recommendations and comments provided by the FDA in response to our pre-Phase 2 submission,” said Tony isaac, President and CEO of JanOne. “As a general rule, it is in the best interest of the drug sponsor – and helpful for the FDA – to hold pre-Phase 2 meetings as the early interactions between the two parties can lead to the effective and efficient application of the guidelines. in trials and potentially reduce the number of review cycles between trial phases in the drug development process. We appreciate the interest and willingness of the FDA to discuss our clinical plans prior to our next submission. “
Tony Giordano, Ph.D., Scientific Director of JanOne commented: “We are very satisfied with the thorough review of our pre-phase 2b FDA briefing documents. We are now working with our partners to incorporate all recommendations and comments provided by the FDA into our phase 2b protocol and supporting documents and we believe that will result in a much more robust study. Our wish is to bring a drug to the market as soon as reasonably possible to start treating patients with PAD and to provide them with a therapeutic benefit that is not available to them with current treatments. “
PAD is a chronic disorder that reduces blood flow to the extremities, resulting in severe pain, limited mobility, and in some cases, death. In United States, estimates are that PAD affects more than 8.5 million people with an annual cost of care of more than $ 10 billion per year. When treated for pain associated with PAD, 25% of patients are at risk for opioid prescriptions. By treating PAD at the source, the need for pain relieving drugs, which are often dangerous and highly addictive opioids, is removed.
JAN101 is a slow release, orally administered twice daily formulation of therapeutic sodium nitrite, an FDA approved compound. JAN101 Phase 2a clinical trial results support the use of sodium nitrite for the treatment and prevention of PAD. An unexpected finding from the Company’s previous studies was that some patients reported a significant reduction in pain associated with PAD. This led to the development by JanOne of clinical protocols for PAD and PAD-associated pain for the phase 2b testing.
JanOne (Nasdaq: JAN) focuses on developing treatments for conditions that cause severe pain. By relieving pain at the source, JanOne aims to reduce the need for opioid prescriptions to treat pain associated with illness that can lead to opioid abuse. JanOne explores solutions for non-addictive pain relievers. Its lead candidate, JAN101, is for the potential treatment of peripheral artery disease (“PAD”), a disease that affects more than 8.5 million Americans. JAN101 has demonstrated positive results in a phase 2a clinical trial and the Company is currently in preparation for phase 2b trials. JanOne is dedicated to funding resources towards innovation, technology and education for PAD, associated vascular conditions and neuropathic pain. For more information, visit www.janone.com.
Forward-looking statements and cautions
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In accordance with the safe harbor provisions of that law, the statements contained in this document that are forward-looking and include everything else only historical information, including whether the FDA will approve the next phase of the company 2b submission. These forward-looking statements may be identified by words such as “will”, “goals”, “future”, “may”, “expects”, “”, “,,,” “plans”, “believes” , “estimates” and similar statements. JanOne may also make written or oral forward-looking statements in its periodic reports to the United States Securities and Exchange Commission (the “SEC”) on Forms 10-K and 10-Q, Reports information on Form 8-K, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. There can be no assurance that such statements will prove to be correct and there are a number of important factors that could cause actual results to differ. rent materially from those expressed in forward-looking statements made by the company, including, but not limited to, management plans and objectives for future operations or products, market acceptance or future success of our products , and our future financial performance. The Company cautions that these forward-looking statements are further qualified by other factors, including, but not limited to those set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended January 2. 2021 and other documents filed with the SEC (available at http://www.sec.gov). JanOne assumes no obligation to publicly update or revise any statements contained in this release, whether as a result of new information, future events, or otherwise.
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