# US 11,433,101 B2 · Proline-rich polypeptide complex for use in treatment of BDNF-dependent disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,101 B2 - Document ID: US11433101B2 - Status: Granted - Kind: B2 - Application number: 16/917,814 - Filed: 2020-06-30 - Published: 2021-01-21 - Granted: 2022-09-06 - Earliest claimed: 2014-11-04 - Assignees: Geo-Poland sp. z o.o. - Applicants: Geo-Poland Sp. Z.O.O. - Inventors: Wlodzimierz Piotr Dobrzynski; Magdalena Anna Bednarek - Web page: https://patentgrep.com/patent/US11433101B2 ## CPC - A61K 35/20: Milk; Whey; Colostrum - A23C 9/206: {Colostrum; Human milk} - A23L 33/18: Peptides; Protein hydrolysates - A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula} - A61K 38/018: {from milk} - A61K 38/1709: {from mammals} - A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system - A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents - A61P 3/02: Nutrients, e.g. vitamins, minerals - A61P 3/04: Anorexiants; Antiobesity agents - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61P 5/00: Drugs for disorders of the endocrine system - A61P 9/00: Drugs for disorders of the cardiovascular system - A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis - A61P 25/00: Drugs for disorders of the nervous system - A61P 25/02: for peripheral neuropathies - A61P 25/06: Antimigraine agents - A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia - A61P 25/16: Anti-Parkinson drugs - A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia - A61P 25/22: Anxiolytics - A61P 25/24: Antidepressants - A61P 25/26: Psychostimulants, e.g. nicotine, cocaine - A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia - A61P 27/02: Ophthalmic agents - A61P 27/06: Antiglaucoma agents or miotics - A61P 31/18: for HIV - A61P 37/02: Immunomodulators - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00) - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The invention relates to the Proline-Rich Polypeptide complex (PRP) derived from the mammalian colostrum for use in the treatment of the disorders and conditions related to the alterations of the Brain-Derived Neurotrophic Factor level as well as modulation thereof, particularly disorders and conditions wherein therapeutic strategy is based on the increasing of the BDNF concentration in blood. The PRP complex is postulated to be used for nutrition of adults, young children/babies and infants to promote and preserve the proper development and function of both immune and nervous system. PRPs may be used for supplementation of modified milk and infant milk formulae to make it closer to breast milk. ## Claims ### Claim 1 A method of treating disorders and conditions related to a decrease or fluctuations of a Brain-Derived Neurotrophic Factor (BDNF) level, said disorders and conditions comprising mild cognition deficit, depressed mood, memory decline, or concentration and memory difficulties, or pertaining to temporary intensive mental activity and tiredness, wherein BDNF diagnosed in a blood serum is a biomarker of said disorders and conditions, the method comprising administering a Proline-Rich Polypeptide complex to a subject in an amount effective to treat said disorders and conditions, the Proline-Rich Polypeptide complex having a molecular weight of up to 10 kDa comprising 16-22% of proline, derived from the mammalian colostrum. ### Claim 2 (depends on 1) The method according to claim 1, wherein administering comprises administering orally in the cases of low levels of the BDNF diagnosed in the blood serum. ### Claim 3 (depends on 1) The method according to claim 1, wherein the amount of the Proline-Rich Polypeptide complex administered is effective to increase the efficiency of short-term visual memory, improve learning abilities and spatial memory, increase the speed of reaction in response to a stimulus, improve the ability to focus and/or to concentrate. ### Claim 4 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex is administered as a nutritional additive for older babies after breastfeeding, for children, and for adults. ### Claim 5 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex is administered as a nutritional additive for pregnant women, in order to increase the BDNF level in the blood of a mother and a baby. ### Claim 6 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex is administered as an additive in a Proline-Rich Polypeptide-enriched formula for older babies after breastfeeding, in order to increase the BDNF level in a baby blood. ### Claim 7 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex is administered as an additive in an infant nutritional milk formula, in order to increase the BDNF level in an infant blood, to the level being at least comparable to the level detected in the blood of breastfed baby. ### Claim 8 (depends on 7) The method according to claim 7, wherein the Proline-Rich Polypeptide complex is administered as an additive in an infant nutritional milk formula, to nourish infants belonging to the group comprising infants who had not been breasted from birth and infants post weaning from mother's milk, said infants being additionally diagnosed with a low Brain-Derived Neurotrophic Factor level in the blood. ### Claim 9 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex is isolated from the bovine or any other farm animal colostrum. ### Claim 10 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex comprises about 18% of acidic amino acids. ### Claim 11 (depends on 10) The method according to claim 10, wherein the Proline-Rich Polypeptide complex is free of the β-lactoglobulin fraction. ### Claim 12 (depends on 1) The method according to claim 1, wherein the Proline-Rich Polypeptide complex is administered as a medicament formulated to provide a pharmaceutical composition, or is in the form of nutraceutic, nutritional supplement, food for a special medical purpose, food for particular nutritional uses or dietary supplement. ### Claim 13 (depends on 12) The method according to claim 12, wherein said medicament is comprising effectively daily dose of the Proline-Rich Polypeptide complex for adults within the range 50-1000 micrograms. ### Claim 14 (depends on 13) The method according to claim 13, wherein said effectively daily dose of the Proline-Rich Polypeptide complex is in the range 80-160 micrograms. ### Claim 15 (depends on 12) The method according to claim 12, wherein said medicament is formulated for pregnant women and comprising effectively daily dose of the Proline-Rich Polypeptide complex within the range 50-140 micrograms. ### Claim 16 (depends on 12) The method according to claim 12, wherein said medicament is formulated to be included in a Proline-Rich Polypeptide-enriched formula for infants to comprise about 20 micrograms of Proline-Rich Polypeptide complex per 100 g. ### Claim 17 (depends on 12) The method according to claim 12, wherein said medicament is formulated to be included in a Proline-Rich Polypeptide-enriched formula for infants in an amount sufficient to meet the daily infant's requirement for Proline-Rich Polypeptide complex within the range of 1 to 5 micrograms per 1 kilogram of body weight.