IP Library › Granted Patent US 12,377,112
Granted Patent B2
US 12,377,112 · App. 17/604,606 · Granted Aug 5, 2025

Methods of treating neurocognitive disorders, chronic pain and reducing inflammation

Inventors: Derek John Londesbrough (Hartlepool, GB); Christopher Brown (Gateshead, GB); Julian Scott Northen (South Shields, GB); Gillian Moore (Sedgefield, GB); Hemant Kashinath Patil (Surrey, GB); David E. Nichols (Chapel Hill, NC); Hans Ake Eriksson (Altrincham, GB); George Goldsmith (Altrincham, GB); Ekaterina Malievskaia (Altrincham, GB); Manon Cecile Elisabeth Veraart (Altrincham, GB); Tobias Patrick Whelan (Altrincham, GB); Lars Christian Wilde (Altrincham, GB)
Assignee: Compass Pathfinder Limited
A61K31/675A61K9/0053A61K9/20A61K9/48A61K31/661A61P25/00A61P25/04A61P25/08A61P25/16A61P25/20A61P25/22A61P25/24A61P25/28C07F9/5728C07B2200/13
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Quick Facts
Patent No.
US 12,377,112
App. No.
17/604,606
Granted
Aug 5, 2025
Kind
B2
Abstract

The disclosure provides methods for treating a subject in need thereof comprising administering to the subject a therapeutically-effective dose of psilocybin. The methods described herein may be used to treat a variety of diseases, disorders, and conditions. 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.

Claims (27)

1. A method for treating attention-deficit hyperactivity (ADHD) disorder in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of crystalline psilocybin, wherein the crystalline psilocybin is characterized by XRPD peaks at 11.5±0.1, 12.0±0.1, 14.5±0.1, 17.5±0.1 and 19.7±0.1° 2θ, and wherein the crystalline psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis.

2. The method of claim 1 , wherein the subject has an attention-deficit hyperactivity subtype selected from predominantly inattentive, predominantly hyperactive/impulsive, or combined presentation.

3. The method of claim 1 , wherein the subject has one or more conditions comorbid with ADHD selected from oppositional defiant disorder, learning difficulties, depression, bipolar disorder, substance use disorder, autism spectrum disorder, personality disorder, or obsessive compulsive disorder.

4. The method of claim 3 , wherein the one or more conditions comorbid with ADHD is oppositional defiant disorder.

5. The method of claim 1 , wherein the subject has a reduced ADHD Rating Scale V score after administration of the crystalline psilocybin.

6. A method for treating an autism spectrum disorder (ASD) or a symptom thereof in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of crystalline psilocybin, wherein the crystalline psilocybin is characterized by XRPD peaks at 11.5±0.1, 12.0±0.1, 14.5±0.1, 17.5±0.1 and 19.7±0.1° 2θ, and wherein the crystalline psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis.

7. The method of claim 6 , wherein the subject has one or more conditions comorbid with ASD selected from an attention-deficit hyperactivity disorder, a sleep-wake disorder, an impulse-control disorder, disruptive behavior, a conduct disorder, a depressive disorder, obsessive-compulsive disorder, bipolar disorder, or schizophrenia.

8. The method of claim 6 , wherein the subject has one or more conditions comorbid with ASD selected from an inflammatory disorder, a gastrointestinal disorder, or epilepsy.

9. The method of claim 6 , wherein the subject has depression.

10. The method of claim 6 , wherein the subject has a reduced Vineland-II Adaptive Behavior (VABS-2) score after administration of the crystalline psilocybin.

11. The method of claim 6 , wherein the subject has a reduced proxy version-t score on the Social Responsiveness Scale, Second Edition (SRS-2) after administration of the crystalline psilocybin.

12. The method of claim 6 , wherein the crystalline psilocybin has no single impurity of greater than 1%.

13. The method of claim 6 , wherein the crystalline psilocybin is administered in an oral dosage form.

14. The method of claim 6 , wherein about 1 mg to about 40 mg of the crystalline psilocybin is administered.

15. The method of claim 6 , wherein about 1 mg of the crystalline psilocybin is administered.

16. The method of claim 6 , wherein about 5 mg of the crystalline psilocybin is administered.

17. The method of claim 6 , wherein about 10 mg of the crystalline psilocybin is administered.

18. The method of claim 6 , wherein about 25 mg of the crystalline psilocybin is administered.

19. The method of claim 6 , wherein the crystalline psilocybin is further characterized by at least one peak selected from the group consisting of 20.4±0.1, 22.2±0.1, 24.3±0.1, and 25.7±0.1° 2θ.

20. The method of claim 1 , wherein the crystalline psilocybin has no single impurity of greater than 1%.

21. The method of claim 1 , wherein the crystalline psilocybin is administered in an oral dosage form.

22. The method of claim 1 , wherein about 1 mg to about 40 mg of the crystalline psilocybin is administered.

23. The method of claim 1 , wherein about 1 mg of the crystalline psilocybin is administered.

24. The method of claim 1 , wherein about 5 mg of the crystalline psilocybin is administered.

25. The method of claim 1 , wherein about 10 mg of the crystalline psilocybin is administered.

26. The method of claim 1 , wherein about 25 mg of the crystalline psilocybin is administered.

27. The method of claim 1 , wherein the crystalline psilocybin is further characterized by at least one peak selected from the group consisting of 20.4±0.1, 22.2±0.1, 24.3±0.1, and 25.7±0.1° 2θ.

Assignments (3)
PATENT SECURITY AGREEMENT Recorded Jun 30, 2023
From: COMPASS PATHWAYS PLC; COMPASS PATHFINDER HOLDINGS LIMITED; COMPASS PATHFINDER LIMITED; COMPASS PATHWAYS, INC.
To: HERCULES CAPITAL, INC.
Reel/Frame 064184/0068 →
CORRECTIVE ASSIGNMENT TO CORRECT THE 20TH INVENTOR'S EXECUTION DATE FROM OCTOBER 18,2021 TO OCTOBER 18, 2020 PREVIOUSLY RECORDED AT REEL: 057922 FRAME: 0676. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Feb 10, 2022
From: LONDESBROUGH, DEREK JOHN; BROWN, CHRISTOPHER; NORTHEN, JULIAN SCOTT; MOORE, GILLIAN; PATIL, HEMANT KASHINATH; NICHOLS, DAVID E.; CROAL, MEGAL; ERIKSSON, HANS AKE; GOLDSMITH, GEORGE; HICKEY, MOLLY TABITHA; HURLEY, SHAUN; MALIEVSKAIA, EKATERINA; MARWOOD, LINDSEY; MCCULLOCH, DRUMMOND E-WEN JOE; MEDHURST, LAURA EMMA; POULSEN, NATHAN; SELIMBEYOGLU, ASLIHAN; SOULA, ANAIS; SHUXIANG, AMANDA TAN; VERAART, MANON CECILE ELISABETH; WHELAN, TOBIAS PATRICK; WILDE, LARS CHRISTOPHER; WRIGHT, STEPHEN
To: COMPASS PATHFINDER LIMITED
Reel/Frame 059002/0467 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2021
From: LONDESBROUGH, DEREK JOHN; BROWN, CHRISTOPHER; NORTHEN, JULIAN SCOTT; MOORE, GILLIAN; PATIL, HEMANT KASHINATH; NICHOLS, DAVID E.; CROAL, MEGAN; ERIKSSON, HANS AKE; GOLDSMITH, GEORGE; HICKEY, MOLLY TABITHA; HURLEY, SHAUN; MALIEVSKAIA, EKATERINA; MARWOOD, LINDSEY; MCCULLOCH, DRUMMOND E-WEN JOE; MEDHURST, LAURIE EMMA; POULSEN, NATHAN; SELIMBEYOGLU, ASLIHAN; SOULA, ANAIS; TAN SHUXIANG, AMANDA; VERAART, MANON CECILE ELISABETH; WHELAN, TOBIAS PATRICK; WILDE, LARS CHRISTIAN; WRIGHT, STEPHEN
To: COMPASS PATHFINDER LIMITED
Reel/Frame 057922/0676 →
Continuity (21)
Provisional Application 62946159 · Dec 10, 2019
Provisional Application 62893611 · Aug 29, 2019
Provisional Application 62893110 · Aug 28, 2019
Provisional Application 62835480 · Apr 17, 2019
Provisional Application 62835478 · Apr 17, 2019
Provisional Application 62835460 · Apr 17, 2019
Provisional Application 62835458 · Apr 17, 2019
Provisional Application 62835479 · Apr 17, 2019
Provisional Application 62835476 · Apr 17, 2019
Provisional Application 62835449 · Apr 17, 2019
Provisional Application 62835474 · Apr 17, 2019
Provisional Application 62835477 · Apr 17, 2019
Provisional Application 62835465 · Apr 17, 2019
Provisional Application 62835450 · Apr 17, 2019
Provisional Application 62835464 · Apr 17, 2019
Provisional Application 62835472 · Apr 17, 2019
Provisional Application 62835482 · Apr 17, 2019
Provisional Application 62835485 · Apr 17, 2019
Provisional Application 62835484 · Apr 17, 2019
Provisional Application 62835481 · Apr 17, 2019
Related Publication 20220169668A1 · Jun 2, 2022
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