Compositions and methods for treating Crohn's Disease and related conditions and infections
Inventors
Assignees
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Publication Number
US-11938184-B2
Publication Date
2024-03-26
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 disclosed invention relates to a method for treating or ameliorating Crohn’s Disease, a complication of a Crohn’s Disease, or a Crohn’s Disease-related fistulae. The method administers to an individual in need thereof a therapeutic combination that includes at least one anti-TNFα composition or drug, or at least one composition or drug capable of down-modulating or down-regulating a TNFα activity, together with at least two anti-Mycobacterium avium sub species paratuberculosis (MAP) agents.
The document positions the therapy as a triple combination approach intended for mammals, including Crohn’s Disease contexts such as terminal/distal ileitis and Johne’s disease and related fistulae. It ties TNFα activity to biological outcomes described in the document.
The document describes biological and multimodal mechanisms associated with the combination, including TNFα-associated autophagy and apoptosis, and additional proposed effects such as improved blood flow/angiogenesis and MAP-targeting. The therapeutic combination is presented in a coordinated regimen, with embodiments that include anti-TNFα agents and anti-MAP agents together with hyperbaric oxygen treatment (HBOT).
Claims Coverage
The partial claim set provided includes one independent claim directed to a therapeutic combination for Crohn’s Disease and Crohn’s Disease-related fistulae. The independent claim requires a TNFα-targeting component with multiple anti-MAP agents, and dependent claims refine the composition details and dosing-related refinements mentioned in the partial content.
Therapeutic TNFα-targeting plus at least two anti-MAP agents combination
A method for treating or ameliorating a Crohn’s Disease, a complication of a Crohn’s Disease, or a Crohn’s Disease-related fistulae, comprising administering to an individual in need thereof a therapeutic combination including at least one anti-TNFα composition or drug, or at least one composition or drug capable of down-modulating or down-regulating a TNFα activity; and at least two anti-Mycobacterium avium sub species paratuberculosis (MAP) agents.
At least three anti-MAP agents with anti-TNFα component
The method includes administering at least one anti-TNFα composition or drug, or TNFα down-modulating/down-regulating composition, together with at least three anti-Mycobacterium avium sub species paratuberculosis (MAP) agents.
Selected anti-MAP agent combinations
The at least three anti-MAP agents are selected as one of the listed combinations, including combinations that incorporate specified anti-MAP agents named in the partial content.
Rifabutin included among the anti-MAP agents
The at least two anti-MAP agents include rifabutin.
Dosing frequency constraints for unit dosage components
A unit dose of at least one anti-MAP or at least one anti-TNFα composition, drug, or formulation is administered with a dosing frequency of bid, tid, four times daily, five times daily, six times daily, or more.
TNFα activity linked to autophagy or apoptosis
TNFα activity acts by causing autophagy or apoptosis in a cell.
The inventive coverage centers on a therapeutic combination that pairs TNFα targeting with multiple anti-MAP agents, with dependent refinements requiring at least three anti-MAP agents, specifying rifabutin-containing and other listed anti-MAP combinations, adding dosing-frequency constraints, and linking TNFα activity to autophagy or apoptosis.
Stated Advantages
Treating or ameliorating Crohn’s Disease, Crohn’s Disease complications, or Crohn’s Disease-related fistulae.
Providing a therapeutic combination that includes TNFα-targeting together with anti-MAP agents for the treatment described.
Documented Applications
Treating or ameliorating Crohn’s Disease in mammals, including contexts described as Crohn syndrome/terminal/distal ileitis and related fistulae.
Treating or ameliorating Crohn’s Disease-related fistulae, including recto-vaginal fistula referenced in the partial content.
Related Johne’s disease and related fistulae are referenced within the described treatment context.
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