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Publication Number
US-12048733-B2
Publication Date
2024-07-30
Expiration Date
Abstract
The present invention relates to methods of treating an auditory disorder. In particular, the present invention relates to treating an auditory disorder using supraparticles comprising a therapeutic payload.
Core Innovation
The invention relates to methods of treating an auditory disorder in a human subject by administering to an ear a supraparticle comprising a therapeutic payload. The therapeutic payload comprises a neurotrophic factor, and spiral ganglion neuron (SGN) survival is observed across a wide extent of the subject’s cochlea, wherein the auditory disorder comprises hearing loss.
The disclosure centers on supraparticle-mediated delivery of neurotrophic factor payloads to the ear for supporting SGN survival across a wide extent of the cochlea. The disclosure further characterizes the delivery as enabling re-establishment of auditory synapses and includes observations consistent with SGN survival and synaptic recovery.
The disclosure provides therapeutic payload options for the neurotrophic factor component and also contemplates additional therapeutic payloads, including steroids, thereby addressing auditory disorder treatment in humans where hearing loss is present. The disclosure includes example supraparticle-mediated neurotrophin delivery to inner ear locations and discusses persistence and distribution over time together with biocompatibility and tissue response.
Claims Coverage
The independent claim covers administering to an ear a supraparticle having a therapeutic payload that comprises a neurotrophic factor, with observation of SGN survival across a wide extent of the cochlea for an auditory disorder comprising hearing loss. The dependent claims refine this core by specifying the neurotrophic factor selection, payload composition and additional payload components including steroids, quantitative neurotrophin content constraints, and particular administration locations within the ear.
Treating an auditory disorder with neurotrophic factor supraparticles and wide-extent SGN survival
Administering to an ear of a human subject a supraparticle comprising a therapeutic payload, wherein the therapeutic payload comprises a neurotrophic factor, and wherein spiral ganglion neuron (SGN) survival is observed across a wide extent of the subject’s cochlea, wherein the auditory disorder comprises hearing loss.
Neurotrophic factor payload selection
A neurotrophic factor selected from BDNF, nerve growth factor, neurotrophin-3, neurotrophin-4, CNTF, GDNF, or IL-11.
Quantitative neurotrophin payload amount
The supraparticle includes between 1.5 μg and 15 μg of neurotrophin.
Round window or oval window administration
Administering the supraparticle to subjects at the round window or the oval window.
BDNF combined with at least one additional named therapeutic payload
The supraparticle comprises BDNF and at least one therapeutic payload selected from neurotrophin-3, neurotrophin-4, CNTF, and GDNF.
Steroid payload as dexamethasone
The supraparticle is carried out using the steroid dexamethasone.
Overall, the claim set centers on supraparticles carrying neurotrophic factors for treating hearing loss by observing SGN survival across a wide cochlear extent, with dependent claims refining the neurotrophic factor selection, adding optional quantitative constraints and additional payload components including dexamethasone, and specifying particular administration location at the round window or the oval window.
Stated Advantages
Provides observation of spiral ganglion neuron (SGN) survival across a wide extent of the cochlea.
Supports auditory synapses re-establishment, consistent with synaptic recovery following neurotrophin supraparticle treatment.
Improves SGN density and synapse recovery after BDNF supraparticle treatment.
Sustained neurotrophin distribution and retention over time.
Biocompatibility and tissue response are discussed in connection with the supraparticle delivery approach.
Documented Applications
Treating an auditory disorder in a human subject where the auditory disorder comprises hearing loss.
Treating hearing loss by administering a supraparticle with a neurotrophic factor payload to an ear of the subject, including delivery associated with inner ear locations such as the round window or the oval window.
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