Compositions and methods for treating Crohn's disease and related conditions and infections
Inventors
Assignees
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Publication Number
US-10946091-B2
Publication Date
2021-03-16
Expiration Date
Abstract
In alternative embodiments, the invention provides a “triple combination” therapy for treating, ameliorating and preventing Crohn's Disease (or Crohn syndrome, terminal or distal ileitis or regional enteritis) or related disorders and conditions in mammals, such as paratuberculosis in mammals, or Johne's disease, including genetically-predisposed and chronic disorders, where the microbial or bacterial flora of the bowel is at least one causative or symptom-producing factor; and compositions for practicing same. In alternative embodiments, methods and compositions of the invention comprise or comprise use of therapies, medications, formulations and pharmaceuticals comprising active agents that can suppress or eradicate the microbiota super-infection that causes Crohn's Disease or paratuberculosis infection in mammals. In alternative embodiments, the methods and uses of the invention for treating, ameliorating and preventing Crohn's Disease and complications of Crohn's Disease, or related disorders and conditions in mammals, such as paratuberculosis in mammals, or Johne's disease, comprises administration to an individual (human or mammal) in need thereof: (1) an anti-TNFα composition, or a composition capable of down-modulating TNFα activity; (2) a Hyperbaric Oxygen Treatment, or HBOT; and (3) an anti Mycobacterium avium sub species paratuberculosis (MAP) (an anti-MAP) agent, composition or therapy.
Core Innovation
The document describes a therapeutic combination for Crohn’s disease, including Crohn syndrome, terminal/distal ileitis, and regional enteritis, that incorporates paratuberculosis targeting. The combination includes an anti-TNFα composition or drug, or a composition or drug capable of down-modulating or down-regulating TNFα activity, together with anti-Mycobacterium avium subspecies paratuberculosis (MAP) agents.
The TNFα component is framed in relation to TNFα activity, including effects such as autophagy and apoptosis. The anti-MAP component includes at least two MAP agents, with specific anti-MAP agents such as rifabutin and clofazimine identified as part of the required set.
The document further provides a broader combination concept associated with infection/MAP targeting and TNFα suppression, alongside adjuncts including biofilm-disrupting compounds, quorum-sensing inhibitors, and probiotics/prebiotics. It also discusses outcomes including fistula healing and reports MRI/colonoscopy outcomes in described clinical examples.
Claims Coverage
The independent claims are directed to a therapeutic combination with four inventive features: an anti-TNFα or TNFα down-modulating/down-regulating component, at least two anti-Mycobacterium avium subspecies paratuberculosis (MAP) agents, specific anti-TNFα binding targets, and a TNFα activity link to autophagy or apoptosis.
Anti-TNFα with down-modulating TNFα activity plus anti-MAP agent combination
A therapeutic combination comprising at least one anti-TNFα composition or drug, or at least one composition or drug capable of down-modulating or down-regulating TNFα activity, and at least two anti-Mycobacterium avium subspecies paratuberculosis (MAP) agents.
Anti-TNFα binding to TNFα, a TNFα receptor, or a TNFα downstream effector
The anti-TNFα composition or drug capable of down-regulating TNFα activity consists of a protein, peptide, or antibody specifically binding to TNFα, a TNFα receptor, or a TNFα downstream effector.
Autophagy or apoptosis driven by TNFα activity
The therapeutic combination is configured so that TNFα activity causes autophagy or apoptosis in a cell.
Increasing MAP-agent requirement
The at least two anti-Mycobacterium avium subspecies paratuberculosis (MAP) agents requirement is increased to at least three anti-MAP agents for an individual or patient.
Overall claim coverage centers on combining an anti-TNFα or TNFα down-modulating/down-regulating component with multiple anti-MAP agents, with further constraints on binding targets and TNFα-mediated autophagy or apoptosis, plus a refinement increasing the number of anti-MAP agents.
Stated Advantages
High fistula-healing rates, with described cases reporting near 100% fistula healing.
Documented Applications
Treatment of Crohn’s disease, including Crohn syndrome, terminal/distal ileitis, and regional enteritis, associated with paratuberculosis/Johne’s disease, including targeting recto-vaginal fistula and perianal fistula.
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