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TNI BioTech has signed a licensing agreement to acquire the exclusive patent rights for the intellectual property of Dr. Jill Smith and LDN Research LLC, whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low dose as an opioid antagonist. Endogenous opioids and opioid antagonists have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues.
As part of the Agreement, TNI BioTech has the right to apply to the Food and Drug Administration (FDA) for the transfer of the orphan drug status, the investigational new drug applications (INDs), and the right to acquire the relevant clinical data set from Dr. Smith. The FDA has designated orphan drug status for the use of low dose naltrexone in the treatment of pediatric patients with Crohn's disease and ulcerative colitis.
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Naltrexone in low dose has been well tolerated in almost all patients, and it showed significantly greater treatment efficacy than the control group in both trials. TNI BioTech is now planning to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment for patients with Crohn's disease using naltrexone in low dose. A platform immunomodulatory technology, naltrexone in low dose also is expected to be clinically tested for treatment of other immune-mediated or immune-deficient diseases, for which the company has previously acquired additional patents.
