JP-2025525990-A5 -

Dates

Publication Date

20260507

Application Date

20230804

Description

The embodiments of the present invention also include the following:Appearance 1Brain-derived neurotrophic factor (BDNF) for use in the prevention or treatment of sensorineural hearing loss in a subject, wherein the BDNF is administered intranasally to the subject.Embodiment 2: The BDNF for use according to Embodiment 1, wherein the sensorineural hearing loss is due to a non-genetic etiology.Embodiment 3: BDNF for use according to Embodiment 2, wherein the sensorineural hearing loss due to a non-genetic etiology is caused by noise exposure, bacterial or viral infection, treatment with ototoxic drugs, autoimmune disease or aging.Embodiment 4: The BDNF for use according to Embodiments 1 to 3, wherein the BDNF is human BDNF, more preferably recombinant human BDNF.Embodiment 5 BDNF for use according to Embodiments 1 to 4, wherein the BDNF is administered 1 to 3 times a day for a treatment period of 7 to 300 days, preferably 60 to 240 days, more preferably 100 to 200 days.Embodiment 6: BDNF for use according to Embodiments 1 to 5, wherein the amount of BDNF per dose is 5 μg to 1 mg, more preferably 10 μg to 400 μg, and even more preferably 15 μg to 200 μg.Appearance 7: See below:BDNF, preferably at a concentration of 5 μg/ml to 1 mg/ml, more preferably 10 μg/ml to 400 μg/ml, and even more preferably 15 μg/ml to 200 μg/ml.NaH2PO4*H2O, preferably at a concentration of 5-8 mg/ml, more preferably 6.9 mg/mL.NaCl, preferably at a concentration of 5 to 6.5 mg/ml, more preferably 5.84 mg/mL.Poloxamer 188, preferably at a concentration of 0.05% w/v to 0.2% w/v, more preferably 0.1% w/v.L-methionine, preferably at a concentration of 0.005 mg/ml to 0.02 mg/ml, more preferably at 0.01 mg/ml.Optionally, n-dodecyl-β-D-maltoside, preferably at a concentration of 0.1% w/v to 1% w/v, more preferably 0.5% w/v.·waterA pharmaceutical composition containing, preferably comprising, these.Embodiment 8 The pharmaceutical composition according to Embodiment 7, wherein the BDNF is human BDNF, more preferably recombinant human BDNF.Embodiment 9 A pharmaceutical composition comprising BDNF and at least one pharmaceutically acceptable excipient for use in the prevention or treatment of sensorineural hearing loss in a subject, wherein the composition is administered intranasally to the subject.Embodiment 10 The pharmaceutical composition for use according to Embodiment 9, wherein the BDNF is human BDNF, more preferably recombinant human BDNF.Embodiment 11 The pharmaceutical composition for use according to Embodiment 9 or 10, wherein the BDNF is contained in the composition at a concentration of 5 μg/ml to 1 mg/ml, more preferably 10 μg/ml to 400 μg/ml, and even more preferably 15 μg/ml to 200 μg/ml.Embodiment 12 A pharmaceutical composition for use according to Embodiments 9 to 11, comprising, preferably comprising, BDNF, sodium chloride, phosphate buffer and water.Aspect 13: A pharmaceutical composition for use according to aspects 9 to 12, wherein the sensorineural hearing loss due to a non-genetic etiology is caused by noise exposure, bacterial or viral infection, treatment with ototoxic drugs, autoimmune disease or aging. The present invention will be further illustrated by the following embodiments, but this will not limit the scope of the invention as defined in the claims.