) ( (51) International Patent Classification: 62/835,485 17 April 2019 (17.04.2019) US A61K 31/4045 (2006.01) A61P25/06 (2006.01) 62/893, 110 28 August 2019 (28.08.2019) US A61K 31/675 (2006.01) A61P25/22 (2006.01) 62/893,61 1 29 August 2019 (29.08.2019) US A61P 25/00 (2006.01) 62/946, 159 10 December 2019 (10. 12.2019) US (21) International Application Number: (71) Applicant: COMPASS PATHFINDER LIMITED PCT/IB2020/053687 [GB/GB]; 3rd Floor, 1 Ashley Road, Altrincham, Cheshire WA14 2DT (GB). (22) International Filing Date: 17 April 2020 (17.04.2020) (72) Inventors: LONDESBROUGH, Derek John; 37 Linden Grove, Hartlepool, Durham TS26 9QA (GB). BROWN, (25) Filing Language: English Christopher; 30 Cherrytree Gardens, Gateshead, Tyne and (26) Publication Language: English Wear NE9 6TY (GB). NORTHEN, Julian Scott; 36 Hep- scott Terrace, South Shields, Tyne and Wear NE33 4TH (30) Priority Data: (GB). MOORE, Gillian; 22 Matfen Court, Sedgefield, 62/835,449 17 April 2019 (17.04.2019) US Durham TS21 2JB (GB). PATIL, Hemant Kashinath; 62/835,450 17 April 2019 (17.04.2019) US 137C Kingston Road, Leatherhead, Surrey KT22 7NT 62/835,458 17 April 2019 (17.04.2019) US (GB). NICHOLS, David E.; 56702 Nash, Chapel Hill, NC 62/835,460 17 April 2019 (17.04.2019) US 27517 (US). CROAL, Megan; c/o COMPASS Pathways 62/835,464 17 April 2019 (17.04.2019) US Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire 62/835,465 17 April 2019 (17.04.2019) US WA14 2DT (GB). ERIKSSON, Hans Ake; c/o COM¬ 62/835,472 17 April 2019 (17.04.2019) US PASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin¬ 62/835,474 17 April 2019 (17.04.2019) US cham Cheshire WA14 2DT (GB). GOLDSMITH, George; 62/835,476 17 April 2019 (17.04.2019) US c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley 62/835,477 17 April 2019 (17.04.2019) US Road, Altrincham Cheshire WA14 2DT (GB). HICKEY, 62/835,478 17 April 2019 (17.04.2019) US Molly Tabitha; c/o COMPASS Pathways Limited, 3rd 62/835,479 17 April 2019 (17.04.2019) US Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT 62/835,480 17 April 2019 (17.04.2019) US (GB). HURLEY, Shaun; c/o COMPASS Pathways Limit¬ 62/835,481 17 April 2019 (17.04.2019) US ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 62/835,482 17 April 2019 (17.04.2019) US 2DT (GB). MALIEVSKAIA, Ekaterina; c/o COMPASS 62/835,484 17 April 2019 (17.04.2019) US (54) Title: METHODS FOR TREATING ANXIETY DISORDERS, HEADACHE DISORDERS, AND EATING DISORDERS WITH PSILOCYBIN Exact Mass: 284 9 id. : 284 25 (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 anxiety disorders, eating disorders, and headache disorders. [Continued on nextpage] \ ( > 2020 2 12 5 1 VI ||||| |||| | III |||||| |||||| I III || |||| |||| |||| III Mill Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). MARWOOD, Lindsey; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). MCCULLOCH, Drummond E-Wen Joe; c/o COMPASS Pathways Limit¬ ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). MEDHURST, Laurie Emma; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin¬ cham Cheshire WA14 2DT (GB). POULSEN, Nathan; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrinch a m Cheshire WA14 2DT (GB). SELIMBE- YOGLU, Aslihan; c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT (GB). SOULA, A na 's: 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, 6 9 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, A Z , 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 FOR TREATING ANXIETY DISORDERS, HEADACHE DISORDERS, AND EATING DISORDERS WITH PSILOCYBIN 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 treatment, therapies or cure exist, including: • Anxiety Disorders: Anxiety disorders are a class of psychiatric disorders that involve extreme fear or worry. Oftentimes, anxiety disorders interfere with daily activities, such as job performance, school work, and relationships. Anxiety disorders have a variety of causes, including changes in the brain, environmental stress, and genetics. Examples of anxiety disorders include acute stress disorder, anxiety due to a medical condition, generalized anxiety disorder, panic disorder, panic attack, a phobia, post-traumatic stress disorder, obsessive-compulsive disorder, separation anxiety disorder, social anxiety disorder, substance-induced anxiety disorder, and selective mutism. • Headache Disorders: Headache disorders are characterized by recurrent headaches and are among the most common disorders of the nervous system. Headaches are a disabling feature of headache disorders, such as migraine, tension-type headache, and cluster headaches. • Eating Disorders: Eating disorders are characterized by irregular eating habits and severe distress or concern about body weight or shape. Eating disturbances may include inadequate or excessive food intake which can ultimately damage an individual’s physical and/or psychological health. Examples of eating disorders include pica, anorexia nervosa, bulimia nervosa, rumination disorder, avoidant/restrictive food intake disorder, and binge eating disorder. There remains a need in the art for improved compositions and methods for treating subjects using psilocybin. SUMMARY Psilocybin may provide numerous clinical benefits, such as benefits in neural plasticity and cognitive function (as measured using e.g., Cambridge Neuropsychological Test Automated Battery (CANTAB) tests ) with improvements in, for example, working memory and executive function, sustained attention, and episodic memory. These benefits have implications for psilocybin’s use in the treatment of various diseases, disorders, and conditions, including both psychiatric and neurological aspects thereof. In some embodiments, a method for treating one or more of anxiety disorders, eating disorders, and headache disorders, comprising administering to the subject an effective amount of psilocybin or an active metabolite thereof is disclosed herein. Provided herein is a method for treating an anxiety disorder in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of psilocybin or an active metabolite thereof.