Method for diagnosing and treating subjects having single nucleotide polymorphisms in chromosome 2, 2:107,510,000-107,540,000 locus
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-11807907-B2
Publication Date
2023-11-07
Expiration Date
Abstract
Methods and products for identifying individuals who are likely to respond in a positive (benefit) or negative (harm) manner to a pharmacological drug treatment intended for treating or preventing a neuropsychiatric disorder, neurodegeneration, sleep-wake cycles such including and not limited to Alzheimer's disease, schizophrenia, autism and attention deficit disorders based on single nucleotide polymorphisms (SNP) chromosome 2, 2:107,510,000-107,540,000 locus (as disclosed in the Genome Reference Consortium Human genome build 37 (GRCh37)).
Core Innovation
The disclosed invention relates to precision-medicine methods and biomarkers for neuropsychiatric and neurodegenerative disorders. It uses single nucleotide polymorphisms comprising specified allele variants at chromosome 2 locus 2:107,510,000–107,540,000 (GRCh37) as genotype predictors for treatment selection.
A central feature is directly detecting that a human subject or patient is a carrier, or is not a carrier, of at least one of the specified alleles at rs12328439 (T>C), rs62155556 (T>A), rs62155557 (G>T), rs62155558 (G>A), rs17033479 (A>G), and rs9789618 (T>A). The detected carrier status is then used to determine whether the subject or patient is treated with a therapeutic agent that is not a melatonin/5-HT1A receptor agonist, or with a melatonin/5-HT1A receptor agonist.
The document further specifies administering piromelatine in carrier cases and melatonin/5-HT1A receptor agonists in non-carrier cases. It also describes treatment selection in terms of genotype-dependent response and includes detection and validation concepts for SNP status, including Sanger sequencing confirmation, together with clinical and statistical results and receptor binding and functional assay data in support of the pharmacologic characterization of melatonin/5-HT1A receptor agonist activity.
Claims Coverage
The independent claim set contains 2 independent claims. Both independent claims share a common core framework: directly detecting whether a human subject or patient is a carrier or not a carrier of specified SNP alleles, and treating with different therapeutic agent classes depending on carrier status, including a melatonin/5-HT1A receptor agonist versus a therapeutic agent that is not a melatonin/5-HT1A receptor agonist.
Direct SNP allele carrier detection for treatment selection
Directly detecting that the human subject or patient is a carrier of an allele comprising at least one specified SNP allele among rs12328439 (T>C), rs62155556 (T>A), rs62155557 (G>T), rs62155558 (G>A), rs17033479 (A>G), and rs9789618 (T>A), and/or directly detecting that the subject or patient is not a carrier of those specified alleles.
Carrier-status dependent choice between melatonin/5-HT1A receptor agonist and non-agonist therapy
Treating based on carrier status by administering a therapeutic agent that is not a melatonin/5-HT1A receptor agonist for a carrier, or administering a melatonin/5-HT1A receptor agonist for a non-carrier.
Piromelatine administration for carrier patients
Administering a therapeutic agent comprising piromelatine to the subject or patient that is a carrier as an alternative treatment option within the carrier-status framework.
Across both independent claims, the inventive coverage is directed to genotype-based decisioning using specified SNP allele carrier status to choose between melatonin/5-HT1A receptor agonist therapy and a therapeutic agent that is not a melatonin/5-HT1A receptor agonist, with piromelatine being used for carrier subjects within the described treatment options.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?