WO 2020/212952 A1 22 October 2020 (22.10.2020)

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WO 2020/212952 A1 22 October 2020 (22.10.2020) (12) INTERNATIONAL APPLICATION PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization iii iiiii min linn ill II Minim mill ill m International Bureau (10) International Publication Number (43) International Publication Date WO 2020/212952 A1 22 October 2020 (22.10.2020) (51) International Patent Classification: 62/946, 159 10 December 2019 (10. 12.2019) U S A61K 31/675 (2006.01) A61P 25/30 (2006.01) (71) Applicant: COMPASS PATHFINDER LIMITED A61K 31/4045 (2006.01) A61P 25/00 (2006.01) [GB/GB]; 3rd Floor, 1 Ashley Road, Altrincham, Cheshire A61P1/00 (2006.01) A61P 25/06 (2006.01) WA14 2DT (GB). A61P 25/16 (2006.01) A61P25/22 (2006.01) (72) Inventors: LONDESBROUGH, Derek John; 37 Linden (21) International Application Number: Grove, Hartlepool, Durham TS26 9QA (GB). BROWN, PCT/IB2020/053688 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, N C (30) Priority Data: 27517 (US). CROAL, Megan; c/o COMPASS Pathways 62/835,449 17 April 2019 (17.04.2019) U S Limited, 3rd Floor, 1 Ashley Road, Altrincham Cheshire 62/835,450 17 April 2019 (17.04.2019) U S WA14 2DT (GB). ERIKSSON, Hans Ake; c/o COM¬ 62/835,458 17 April 2019 (17.04.2019) U S PASS Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin¬ 62/835,460 17 April 2019 (17.04.2019) U S cham Cheshire WA14 2DT (GB). GOLDSMITH, George; 62/835,464 17 April 2019 (17.04.2019) U S c/o COMPASS Pathways Limited, 3rd Floor, 1 Ashley 62/835,465 17 April 2019 (17.04.2019) U S Road, Altrinch am Cheshire WA14 2DT (GB). HICKEY, 62/835,472 17 April 2019 (17.04.2019) U S Molly Tabitha; c/o COMPASS Pathways Limited, 3rd 62/835,474 17 April 2019 (17.04.2019) U S Floor, 1 Ashley Road, Altrincham Cheshire WA14 2DT 62/835,476 17 April 2019 (17.04.2019) U S (GB). HURLEY, Shaun; c/o COMPASS Pathways Limit¬ 62/835,477 17 April 2019 (17.04.2019) U S ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 62/835,478 17 April 2019 (17.04.2019) U S 2DT (GB). MALIEVSKAIA, Ekaterina; c/o COMPASS 62/835,479 17 April 2019 (17.04.2019) U S Pathways Limited, 3rd Floor, 1 Ashley Road, Altrincham 62/835,480 17 April 2019 (17.04.2019) U S Cheshire WA14 2DT (GB). MARWOOD, Lindsey; c/o 62/835,481 17 April 2019 (17.04.2019) U S COMPASS Pathways Limited, 3rd Floor, 1 Ashley Road, 62/835,482 17 April 2019 (17.04.2019) U S Altrinch am Cheshire WA14 2DT (GB). MCCULLOCH, 62/835,484 17 April 2019 (17.04.2019) U S Drummond E-Wen Joe; c/o COMPASS Pathways Limit¬ 62/835,485 17 April 2019 (17.04.2019) U S ed, 3rd Floor, 1 Ashley Road, Altrincham Cheshire WA14 62/893,1 10 2 8 August 2019 (28.08.2019) U S 2DT (GB). MEDHURST, Laurie Emma; c/o COMPASS 62/893,61 1 2 9 August 2019 (29.08.2019) U S Pathways Limited, 3rd Floor, 1 Ashley Road, Altrin- (54) Title: TREATMENT OF DEPRESSION AND OTHER VARIOUS DISORDERS WITH PSILOCYBIN Exact 2 4 0 Mol W : 284 25 (57) Abstract: The disclosure provides methods for treating a subject in need thereof comprising administering to the subject a ther¬ apeutically -effective dose of psilocybin. The methods described herein may b e used to treat a variety of diseases, disorders, and con¬ ditions. For example, the methods may b e used to treat depression, neurocognitive disorders, autism spectrum disorder, and/or atten¬ tion-deficit/hyperactivity disorder. [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 TREATMENT OF DEPRESSION AND OTHER VARIOUS DISORDERS WITH PSILOCYBIN RELATED APPLICATIONS This application claims priority to 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, 110 , filed August 28, 201 9 , 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 Depression is one of the most common mental illnesses, affecting more than 264 million people worldwide. It is characterized by depressed mood and markedly diminished interest or pleasure in activities. Other symptoms include significant weight loss or weight gain, decrease or increase in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive or inappropriate guilt, diminished ability to think or concentrate or indecisiveness, recurrent thoughts of death, suicidal ideation or suicidal attempts. Current treatments for depression often consist of a combination of psychotherapy and one or more daily medications that regulate neurotransmitters such as dopamine, serotonin, and norepinephrine. These medications often take weeks to months to achieve their full effects and in the meantime, individuals continue to suffer from their symptoms and be at risk of self-harm, as well as harm to their personal and professional lives. There remains a need in the art for an effective treatment for depression that provides a rapid onset of antidepressant effects within hours or a few days and is sustained long-term. 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, the disclosure provides a method of treating depression in a subject in need thereof, the method comprising administering an effective amount of psilocybin or an active metabolite thereof to the subject. In some embodiments, the subject has a major depressive disorder, atypical depression, bipolar disorder, catatonic depression, a depressive disorder due to a medical condition, postpartum depression, premenstrual dysphoric disorder, or seasonal affective disorder. In some embodiments, the subject has a depressive disorder that is resistant to treatment.
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