Levocetirizine and montelukast in the treatment of inflammation mediated conditions
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9925183-B2
Publication Date
2018-03-27
Expiration Date
Abstract
The embodiments described herein include methods and formulations for treating viruses and diseases that are exacerbated by inflammatory responses in the body. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of levocetirizine and montelukast to a patient in need. The methods and formulations can comprise conventional and/or modified-release elements, providing for drug delivery to the patient.
Core Innovation
The document describes repurposing a combination therapy comprising levocetirizine and montelukast to treat a patient having an NF-κB-mediated condition. The treatment is directed to conditions in which NF-κB is involved, including inflammation-mediated and NF-κB-mediated neurological disease, and comprises administering an effective amount of the combination of levocetirizine and montelukast to the patient.
The described approach also covers NF-κB-mediated conditions caused by viruses selected from Ebola virus, West Nile virus, Yellow Fever virus, Dengue virus, tick-borne encephalitis virus, and HIV. In addition, the document associates the combination therapy with inflammation pathways including TLRs, MAPKs, IRFs/IFNs, RIG-I-like receptors, and inflammasome/NLRP3-related signaling, including modulation or blocking of inflammatory pathways mediated through NF-κB.
The document further provides drug delivery and formulation concepts for sustained receptor modulation, including conventional and modified or sustained-release formulations and long-acting injectable formats. It describes projected clinical study designs and outcomes including reduced mortality or morbidity and improved symptom resolution with long-acting injectable and combination regimens.
Claims Coverage
The partial content identifies three independent claims covering NF-κB-mediated neurological disease treated with levocetirizine plus montelukast, NF-κB-mediated viral-caused conditions treated with the same combination, and neurodegenerative disease treated with the same combination. Dependent claims further constrain disease subtype selection and administration timing and route relationships, with optional addition of a steroid and use of slow-release composition forms.
NF-κB-mediated neurological disease treated by levocetirizine and montelukast combination
Administering to a patient an effective amount of a combination of levocetirizine and montelukast to treat an NF-κB-mediated condition, wherein the condition is a neurological disease.
Specified NF-κB-mediated neurological disease subtypes
Treating the NF-κB-mediated neurological disease by selecting the neurological disease from a specified list of particular neurodegenerative and related diseases including Alzheimer's disease and other listed disorders.
Sequential administration of levocetirizine and montelukast
Carrying out the method by administering the combination of levocetirizine and montelukast in a sequential manner.
Permitted administration routes for the levocetirizine and montelukast combination
Administering the combination of levocetirizine and montelukast to the patient via one or more specified routes selected from enteral, intravenous, intraperitoneal, inhalation, intramuscular, subcutaneous, and oral.
Same-route administration of levocetirizine and montelukast
Administering levocetirizine and montelukast via the same route.
Addition of a steroid to the levocetirizine and montelukast combination
Further defining the method to include adding a steroid to the levocetirizine–montelukast combination.
NF-κB-mediated viral conditions treated by levocetirizine and montelukast combination
Administering to the patient an effective amount of a combination of levocetirizine and montelukast to treat an NF-κB-mediated condition caused by a virus selected from the group consisting of Ebola virus, West Nile virus, Yellow Fever virus, Dengue virus, tick-borne-encephalitis virus, and HIV.
Sequential administration for viral NF-κB-mediated conditions
Defining the method to include administering levocetirizine and montelukast in a sequential manner for the NF-κB-mediated viral condition.
Substantially simultaneous administration for viral NF-κB-mediated conditions
Administering levocetirizine and montelukast in a substantially simultaneous manner for the NF-κB-mediated viral condition.
Enumerated permitted routes for viral NF-κB-mediated conditions
Specifying that the combination is administered to the patient via one or more of the listed administration routes including enteral, intravenous, intraperitoneal, inhalation, intramuscular, subcutaneous, and oral.
Different-route administration for levocetirizine and montelukast
Further including administering levocetirizine and montelukast through different routes.
Addition of a steroid for viral NF-κB-mediated conditions
Further including adding a steroid to the levocetirizine and montelukast combination for the NF-κB-mediated viral condition.
Neurodegenerative disease treated by levocetirizine and montelukast combination
Administering to a patient an effective amount of a combination of levocetirizine and montelukast to treat a neurodegenerative disease.
Specified neurodegenerative disease subtypes
Applying the method where the neurodegenerative disease is selected from a list including particular disorders such as Alzheimer's disease and Parkinson's disease.
Across the independent claims, the core claimed coverage is methods of treating NF-κB-mediated conditions—particularly neurological and neurodegenerative diseases—by administering an effective amount of a levocetirizine and montelukast combination, including for viral-caused NF-κB-mediated conditions specified by virus group. Dependent claims further constrain disease subtype selection and administration constraints such as sequential versus substantially simultaneous timing, enumerated routes, same-route versus different-route relationships, and optionally adding a steroid.
Stated Advantages
Reduced mortality or morbidity.
Improved symptom resolution.
Documented Applications
Treating a patient having an NF-κB-mediated neurological disease with a combination of levocetirizine and montelukast.
Treating NF-κB-mediated conditions caused by viruses selected from Ebola virus, West Nile virus, Yellow Fever virus, Dengue virus, tick-borne encephalitis virus, and HIV using the levocetirizine and montelukast combination.
Treating neurodegenerative diseases by administering a combination of levocetirizine and montelukast, including disorders such as Alzheimer's disease and Parkinson's disease.
Example narrative: West Nile meningitis treated post-discharge.
Longer-term observational example: an HIV on ART context with improved CD4 counts.
Interested in licensing this patent?