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A61p25/00 (2006.01) A61p29/00 (2006.01) ( (51) International Patent Classification: (71) Applicant: COMPASS PATHFINDER LIMITED A61K 31/4045 (2006.01) A61P 25/08 (2006.01) [GB/GB]; 3rd Floor, 1 Ashley Road, Altrincham, Cheshire A61K 31/675 (2006.01) A61P 25/16 (2006.01) WA14 2DT (GB). A61P25/00 (2006.01) A61P29/00 (2006.01) (72) Inventors: LONDESBROUGH, Derek John; 37 Linden (21) International Application Number: Grove, Hartlepool, Durham TS26 9QA (GB). BROWN, PCT/IB2020/053684 Christopher; 30 Cherrytree Gardens, Gateshead, Tyne and (22) International Filing Date: Wear NE9 6TY (GB). NORTHEN, Julian Scott; 36 Hep- 17 April 2020 (17.04.2020) scott Terrace, South Shields, Tyne and Wear NE33 4TH (GB). MOORE, Gillian; 22 Matfen Court, Sedgefield, (25) Filing Language: English Durham TS21 2JB (GB). PATIL, Hemant Kashinath; (26) Publication Language: English 137C Kingston Road, Leatherhead, Surrey KT22 7NT (GB). NICHOLS, David E.; 56702 Nash, Chapel Hill, NC (30) Priority Data: 27517 (US). CROAL, Megan; c/o COMPASS Pathways 62/835,449 17 April 2019 (17.04.2019) US Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire 62/835,450 17 April 2019 (17.04.2019) US WA14 2DT (GB). ERIKSSON, Hans Ake; c/o COM¬ 62/835,458 17 April 2019 (17.04.2019) US PASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin¬ 62/835,460 17 April 2019 (17.04.2019) US cham Cheshire WA14 2DT (GB). GOLDSMITH, George; 62/835,464 17 April 2019 (17.04.2019) US c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley 62/835,465 17 April 2019 (17.04.2019) US Road, Altrincham Cheshire WA14 2DT (GB). HICKEY, 62/835,472 17 April 2019 (17.04.2019) US Molly Tabitha; c/o COMPASS Pathways Limited, 3rd 62/835,474 17 April 2019 (17.04.2019) US Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT 62/835,476 17 April 2019 (17.04.2019) US (GB). HURLEY, Shaun; c/o COMPASS Pathways Limit¬ 62/835,477 17 April 2019 (17.04.2019) US ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 62/835,478 17 April 2019 (17.04.2019) US 2DT (GB). MALIEVSKAIA, Ekaterina; c/o COMPASS 62/835,479 17 April 2019 (17.04.2019) US Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham 62/835,480 17 April 2019 (17.04.2019) US Cheshire WA14 2DT (GB). MARWOOD, Lindsey; c/o 62/835,481 17 April 2019 (17.04.2019) US COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, 62/835,482 17 April 2019 (17.04.2019) US Altrincham Cheshire WA14 2DT (GB). MCCULLOCH, 62/835,484 17 April 2019 (17.04.2019) US Drummond E-Wen Joe; c/o COMPASS Pathways Limit¬ 62/835,485 17 April 2019 (17.04.2019) US ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 62/893,1 10 28 August 2019 (28.08.2019) US 2DT (GB). MEDHURST, Laurie Emma; c/o COMPASS 62/893,61 1 29 August 2019 (29.08.2019) US Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin- 62/946,159 10 December 2019 (10. 12.2019) US (54) Title: METHODS OF TREATING NEUROCOGNITIVE DISORDERS, CHRONIC PAIN AND REDUCING INFLAM¬ MATION (57) Abstract: The disclosure provides methods for treating a subject in need thereof comprising administering to the subject a thera¬ peutically -effective dose of psilocybin. The methods described herein may be used to treat a variety of diseases, disorders, and condi¬ tions. For example, the methods may be used to treat neurocognitive disorders (e.g., Alzheimer's disease, Parkinson's disease), ADHD, Epilepsy, Autism, Sleep-wake disorders, Chronic pain, Inflammatory Disorders, IBD, Stroke, ALS, and/or Multiple Sclerosis. [Continued on nextpage] chant Cheshire WA14 2DT (GB). POULSEN, Nathan; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). SELIMBE- YOGLU, Aslihan; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). SOULA, Ana'is: c/o COMPASS Pathways Limit¬ ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). SHUXIANG, Amanda Tan; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). VERAART, Manon Cecile Elisabeth; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). WHELAN, Tobias Patrick; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). WILDE, Lars Christian; c/o COM¬ PASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin¬ cham Cheshire WA14 2DT (GB). WRIGHT, Stephen; c/ o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). (74) Agent: COOLEY (UK) LLP; Dashwood, 69 Old Broad Street, London EC2M IQS (GB). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available) : ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: — as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(H)) Published: — with international search report (Art. 21(3)) — before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) — in black and white; the international application as filed contained color or greyscale and is available for download from PATENTSCOPE METHODS OF TREATING NEUROCOGNITIVE DISORDERS, CHRONIC PAIN AND REDUCING INFLAMMATION RELATED APPLICATIONS This application claims priority to and benefit of U.S. Application Serial Nos. 62/835,449; 62/835,450; 62/835,458; 62/835,460; 62/835,464; 62/835,465; 62/835,472; 62/835,474; 62/835,476; 62/835,477; 62/835,478; 62/835,479; 62/835,480; 62/835,481 ; 62/835,482; 62/835,484; and 62/835,485, all filed April 17, 2019; U.S. Application Serial No. 62/893,1 10, filed August 28, 2019, U.S. Application Serial No. 62/893,61 1, filed August 29, 2019, and U.S. Application Serial No. 62/946,159, filed December 10, 2019, each of which is incorporated herein by reference in its entirety. BACKGROUND Psilocybin belongs to a class of drugs referred to as psychedelics (“mind-manifesting” drugs). Specifically, psilocybin is considered a 5-hydroxytryptaminergic (serotonergic) psychedelic, as distinguished from other tryptamines such as dimethyltryptamine (DMT), ergolines such as lysergic acid diethylamide (LSD), and phenethylamines such as mescaline. Psilocybin was first isolated from psilocybe mushrooms and later synthesized in a laboratory. There are several common diseases, disorders, and conditions for which no adequate treatments and/or therapies exist, including: • Alzheimer’s disease (AD) - AD is a neurodegenerative brain disorder characterized by both cognitive and non-cognitive behavioral changes, particularly progressive memory deficits, depression, anxiety, dementia, irritability, mood swings, inattention, aggressive and/or apathetic behavior, confusion, gradual physical deterioration, and ultimately death. • Parkinson’s disease (PD) - PD is the most common type of Parkinsonian syndrome, a term reflecting a group of neurological disorders with Parkinson’s disease-like movements problems such as rigidity, slowness, and tremor. The clinical presentation of Parkinson’s disease includes motor and non-motor symptoms. • Attention-deficit hyperactivity disorder (ADHD) - ADHD is a neurodevelopmental disorder characterized by one or more of inattention, hyperactivity, and impulsivity, which are otherwise not appropriate for a person’s age. It is commonly diagnosed in childhood and is one of the most frequent conditions affecting school-aged children. • Epilepsy - Epilepsy is a neurological disorder marked by sudden recurrent episodes of sensory disturbance, loss of consciousness, or convulsions, associated with abnormal electrical activity in the brain. During a seizure, an individual with epilepsy experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. There are few symptoms between seizures. • Autism spectrum disorder (ASD) - ASD is a neurodevelopmental syndrome characterized by core deficits in social interaction and communication, presence of repetitive and restricted patterns of behavior and interests, and/or unusual reactivity to sensory input. • Sleep-wake disorders - Sleep-wake disorders are a class of diseases or disorders including insomnia disorder, hypersomnolence disorder, narcolepsy, breathing- related sleep disorders (such as central sleep apnea), circadian rhythm sleep- wake disorders, non-rapid eye movement sleep arousal disorders, nightmare disorder, rapid eye movement sleep behavior disorder, restless leg syndrome, and substance/medication-induced sleep disorder. Individuals with these disorders typically present with sleep-wake complaints of dissatisfaction regarding the quality, timing, and amount of sleep, which often results in daytime distress. • Chronic pain - Pain is the most common symptom of disease and provides protection from dangerous and noxious stimuli.
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