JanOne Profile
JanOne Inc., a clinical-stage pharmaceutical company, focuses on finding treatments for conditions that cause severe pain and bringing drugs to market with non-addictive pain-relieving properties.
The company's first drug candidate is a treatment for Peripheral Artery Disease (PAD), a condition that can cause severe pain and affects over 8.5 million people in the United States. The company intends to champion new initiatives-digital technologies, educational advocacy, and revolutionary painkilling drugs.
Biotechnology
The company focuses on identifying, acquiring, licensing, developing, partnering, and commercializing novel, non-opioid and non-addictive therapies to address the large unmet medical need for the treatment of pain and addiction. JAN101, is a potential treatment for PAD, a vascular disease that affects more than 8.5 million people in the U.S. and more than 60 million people worldwide. The company expects to commence Phase IIb/III clinical trials for the treatment of PAD in 2024.
The company focuses on development of new and innovative solutions for ending the opioid epidemic ranging from digital technologies to educational advocacy. It focuses on finding treatments for conditions that cause severe pain and bringing to market drugs with non-addictive pain-relieving properties.
JAN101
JAN 101 is a patented oral, sustained release pharmaceutical composition of sodium nitrite that targets poor blood flow to the extremities, such as those with vascular complications of diabetes or PAD and treats pain. A conclusion from a round of human studies found JAN101 prevents the prevalent reports of headaches by patients treated with an immediate release formulation of sodium nitrite. In a previous study of patients with PAD, a 40 mg BID treatment with immediate release sodium nitrite led to a statistically significant reduction in reported pain, while an 80 mg BID treatment had a more pronounced effect on bioactivity and Flow Mediated Dilation, a measure of vascular function.
Soin Therapeutics
JanOne acquired Soin Therapeutics LLC (Soin Therapeutics), a company focuses on the development of a novel formulation of low-dose naltrexone (LDN) for the treatment of chronic regional pain syndrome (CRPS) in 2022. Prior to the acquisition, Soin Therapeutics received Orphan Drug Designation for the product, which provides a variety of incentives for developing the product in this indication.
JAN123
JAN123 is a novel formulation of 2.0 mg of LDN that results in a biphasic release of the product. The release properties of JAN123 provide for an immediate release of less than half the product with a slow, sustained release of the remaining product. Importantly, the rapid release of LDN has been reported to lead to vivid and lucid unpleasant dreams, which should be eliminated with the formulation of JAN123.
Strategy
The key elements of the company's strategy are to license, acquire, develop, and create novel, non-opioid and non-addictive therapies by leveraging its understanding of pain biology to address the large and growing problem of pain; advance the development of JAN101, designed for the treatment of patients with PAD and pain associated with the disease; leverage clinical activity of JAN101 possibly to expand into new indications; advance JAN101 through clinical development and pursue development of additional product candidates through acquisitions; and maximize the commercial potential of all its product candidates.
Intellectual Property
In 2019, the company entered into a Patent and Know How License Agreement (the 'License Agreement') with UAB Research Foundation (UABRF), TheraVasc Inc. (TheraVasc), and the Board of Supervisors of Louisiana State University and Agricultural and Mechanical College, acting on the behalf of LSU Health Sciences Center in Shreveport, Louisiana (LSU Health Shreveport), together with UABRF and TheraVasc, the 'Licensors'. Under the License Agreement, the Licensors have agreed to grant to JanOne an exclusive, worldwide license, including the right to sublicense, to the Licensors' patent rights and know-how related to the Licensors' sustained release formulation of sodium nitrite. Under the License Agreement, the company has agreed to pay a non-refundable upfront license fee and certain milestone payments upon the achievement of certain milestones and certain royalty payments and annual license maintenance fees. The License Agreement requires the company to use commercially reasonable efforts to develop and commercialize JAN101.
Government Regulation
The FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of drugs, such as those that the company is developing. To market the company's future products in the European Economic Area (the EEA) and many other foreign jurisdictions, it must obtain separate regulatory approvals.
Discontinued Operations
As of September 30, 2023, the company's discontinued operations included Recycling and Technology segments.
History
The company was founded in 1976. It was incorporated in Minnesota in 1983. The company was reincorporated in the state of Nevada in 2018. It was formerly known as Appliance Recycling Centers of America, Inc. and changed its name to JanOne Inc. in 2019.
