Earlier today, TNI BioTech announced that it has entered into an agreement to acquire patent rights to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s Disease.
The patent acquired 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 obtained 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. Jill 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.
A development committee, consisting of independent scientific and technical leaders who are highly regarded by the scientific community, will monitor the clinical progress of the licensed products. This committee will include at least one representative from the licensor parties and one representative from TNI BioTech, in addition to outside experts in the field. The inventors’ input will be highly valued due to their history and expertise with the therapies.
“TNI BioTech is extremely pleased to acquire the exclusive rights to low dose naltrexone and other opioid antagonists for the treatment of inflammatory and ulcerative diseases of the bowel,” stated Noreen Griffin, CEO of TNI BioTech. “We believe that low dose naltrexone has the potential to provide significant relief to those who suffer from Crohn’s disease or other auto-immune disorders of the bowel.”
Low dose naltrexone has already been evaluated in two randomized placebo-controlled phase II trials, one for adult patients with Crohn’s disease and the other for children with Crohn’s disease. 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.
According to today’s press release, TNI BioTech plans to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment of 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.
For more information about TNI Biotech, visit www.TNIBiotech.com
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