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24Hrs Patent Application Publication May 21 , 2020 Sheet 1 of 6 US 2020/0155522 A1 US 20200155522A1 IN (19 ) United States (12 ) Patent Application Publication ( 10 ) Pub . No.: US 2020/0155522 A1 Osten et al. (43 ) Pub . Date : May 21 , 2020 (54 ) GABOXADOL FOR REDUCING RISK OF Publication Classification SUICIDE AND RAPID RELIEF OF (51 ) Int. Ci. DEPRESSION A61K 31/437 (2006.01 ) A61K 31/135 (2006.01 ) ( 71) Applicant: Certego Therapeutics , Farmingdale , A61P 25/24 ( 2006.01 ) NY (US ) (52 ) U.S. CI. (72 ) Inventors: Pavel Osten , Brooklyn , NY (US ) ; CPC A61K 31/437 (2013.01 ) ; A61P 25/24 Kristin Baldwin , San Diego , CA (US ) ( 2018.01 ) ; A61K 31/135 ( 2013.01 ) (73 ) Assignee : Certego Therapeutics, Farmingdale , ( 57 ) ABSTRACT NY (US ) Methods and compositions are disclosed for rapidly reduc (21 ) Appl. No.: 16 /691,049 ing the risk of suicide in patients suffering from acute suicidality and rapidly relieving mood symptoms in major ( 22 ) Filed : Nov. 21 , 2019 depression and treatment - resistant depression using a novel therapeutic regimen comprising a single or intermittent Related U.S. Application Data administration of a high dose of gaboxadol, or a pharma (60 ) Provisional application No.62 / 770,287 , filed on Nov. ceutically acceptable salt thereof, to the subject n need 21 , 2018 . thereof. 220 I ther 24hrs Patent Application Publication May 21 , 2020 Sheet 1 of 6 US 2020/0155522 A1 FIGURE1:METHODFORWHOLE-BRAINPHARMACOMAPSREPRESENTINGDRUGEVOKED ACTIVATIONINTHEMOUSE. Patent Application Publication May 21 , 2020 Sheet 2 of 6 US 2020/0155522 A1 FIGURE 2 : KETAMINE DOSE - CURVE PHARMACOMAPS , Ketamine . 5 mg/ kg SA 0 27 SE es **** $$ *** Patent Application Publication May 21 , 2020 Sheet 3 of 6 US 2020/0155522 A1 GABOXADOL AND KETAMINE SIDE -BY -SIDE PHARMACOMAP COMPARISON somoko *** 3 SURAHIA ES EN Patent Application Publication May 21 , 2020 Sheet 4 of 6 US 2020/0155522 A1 OLDUS COM ALJA cos MARCOS se FIGURE4:SYNERGISTICEFFECTOFCO-APPLICATIONGABOXADOLAND 330* KETAMINEATSUB-THRESHOLDDOSES 0BMW 3 DIE ASE AWS 39 kg mg 5 ketamine kg/ mg 5 gaboxado SMJOU GOpexogen Oxbow Cutelax Patent Application Publication May 21 , 2020 Sheet 5 of 6 US 2020/0155522 A1 ketamine vehicle 24hrs TimeAfterInjection(hrs) 080 160 Patent Application Publication May 21 , 2020 Sheet 6 of 6 US 2020/0155522 A1 Time(hr) AdministrationFollowingGaboxadolConcentrationsofPlasmaMean24Subjects-) (aHealthy Dosesto OralSinglemgof15- 8 om 200 ( 7wbu ) uopaquoouob US 2020/0155522 Al May 21 , 2020 1 GABOXADOL FOR REDUCING RISK OF ence for 8 - subunit containing GABAA receptors . In the SUICIDE AND RAPID RELIEF OF early 1980s gaboxadol was the subject of a series of pilot DEPRESSION studies that tested its efficacy as an analgesic and anxiolytic , as well as a treatment for tardive dyskinesia , Huntington's CROSS - REFERENCE TO RELATED disease , Alzheimer's disease (Mohr , Bruno et al . Clin Neu APPLICATIONS ropharmacol. 1986 ; 9 ( 3 ) :257-63 ) , and spasticity . In the 1990s gaboxadol moved into late stage development for the [0001 ] This application claims priority to Provisional Pat treatment of insomnia . The development was discontinued ent Application No. 62/ 770,287 filed on Nov. 21, 2018 , the after the compound failed to show significant effects in sleep content of which is incorporated by reference herein in their onset and sleep maintenance in a three -month efficacy study . entirety. (Methods of treating depression with low doses of gabox adol are disclosed in WO2004112786 , which is incorporated FIELD OF THE EMBODIMENTS by reference herein in its entirety . A clinical trial to inves [ 0002] This invention relates to methods and compositions tigate the efficacy of gaboxadol in the treatment of symp for rapidly reducing the risk of suicide in patients suffering toms of Angelman Syndrome (a developmental disorder ) from acute suicidality and rapidly relieving mood symptoms sponsored by Ovid Therapeutics Inc. (Clinical Trials.gov in major depression and treatment - resistant depression using Identifier: NCT02996305 ) is currently underway (Cogram , a novel therapeutic regimen comprising a single or inter Deacon et al. 2019 ). Patent applications on related subject mittent administration of a high dose of gaboxadol, or a matter include U.S. Pat. No. 9,744,159, published US Patent pharmaceutically acceptable salt thereof, to the subject in Application No. 2017/348232 and WIPO International Pat need thereof. ent Application WO2017015049 , the contents of which are incorporated herein by reference in their entireties . BACKGROUND OF THE EMBODIMENTS [ 0005 ] Methods of treating depression with low doses of [ 0003] According to the World Health Organization , gaboxadol are disclosed in WO2004112786 , which is incor depression is the leading cause of disability and ill health in porated by reference herein in its entirety . the world affecting more than 300 million people worldwide [0006 ] A clinical trial by Lundbeck reported at Clinical and costing the global economy an estimated $ 1 trillion in Trialss.gov . Identifier : NCT00807248 treated 490 patients lost productivity each year . The Centers for Disease Control with daily oral doses of escitalopram ( 20 mg) and gaboxadol (CDC ) estimate that in the U.S. alone , 20-25 % of all adults ( 5 mg or 10 mg) . The trial found that oral gaboxadol at this aged 18 and older and 10.9 % of young adults aged 18-25 amount provided no additional benefit in the treatment of experience at least one episode of major depression each patients with severe major depressive disorder . A report on year. Left untreated , mental diseases , like major depression , this trial is found at Kaspar et al (2012 ) Int J Neuropsy are a major contributor to suicide in the US which takes the chopharmacol. 2012 July ; 15 (6 ) :715-25 . test for effects on lives of more than 47,000 Americans every year or one death patients diagnosed with suicidal ideation or identified as at by suicide every 11 minutes (Shepard et al. , Suicide Life risk of suicide . The trial also did not test the effect of Threat Behav. ( 2016 ) 46 ( 3 ) 352-62 . ). There is one suicide for gaboxadol alone. every estimated 25 suicide attempts which means each year there are an estimated quarter million people who become [ 0007] Gaboxadol ( 4,5,6,7 - tetrahydroisoxazolo [ 5,4 - c ] suicide survivors . Hence , there is a critical unmet need for pyridine - 3 - ol) ( THIP ) ) is also described in EP Patent No. rapid -acting medications for the treatment of suicidal ide 0000338 and in EP Patent No. 0840601 , U.S. Pat. Nos . ation and treatment- resistant depression ( TRD ) . 4,278,676 , 4,362,731, 4,353,910 , and WO 2005/094820 , the [ 0004 ] Recently , esketamine ( Spravato ) delivered intrana contents of which are hereby incorporated by reference sally has been approved by the US Food and Drug Admin herein in their entireties . istration (FDA ) as the first rapid acting antidepressant , [0008 ] None of the art described above addresses the bringing hope to patients with TRD and acute suicidal urgent treatment of patients suffering from acute suicidality ideation (Bahr et al ., 2019 ; Pochwat et al ., 2019 ) . Esket and treatment- resistant depression by administering a high amine indeed shows a remarkably rapid efficacy , with posi dose ( e.g. , > 50 mg per dose ) gaboxadol once or intermit tive therapeutic effects seen with a day or only a few days tently every three days or more . post dosing, in contrast to traditional antidepressants that take weeks to achieve efficacy (Krystal et al ., 2019 , Neuron SUMMARY OF THE EMBODIMENTS 101, 774-778 ; Harmer et al ., 2009 ; The British Journal of Psychiatry 195 , 102-108 ; Uher et al. , 2010 , Psychological [0009 ] Methods of reducing risk of suicide and / or achiev Medicine 40 , 1367-1377 ) . However , esketamine is also ing rapid relief of depression symptoms described herein associated with significant side effects, including psychosis include administering to a patient in need thereof an amount like psychotomimetic side effects with delusions and of gaboxadol or a pharmaceutically acceptable salt thereof delirium and drug abuse liability . The psychotomimetic side sufficient to reduce the risk of suicide. Methods of reducing effects are of a particular concern in TRD and suicidal risk of suicide and achieving rapid relief from depression patients and therefore Spravato can be only administered in described herein include administering to a patient in need doctor's office where patients must bemonitored by a health thereof a first single dose treatment of about 50 mg to about professional for at least 2 hours post dose. Therefore there is 300 mg gaboxadol or a pharmaceutically acceptable salt a continuing need for the development of safer therapeutic thereof wherein the first treatment provides improvement in options with similar rapid efficacy as esketamine . Gabox the patient within 1 day and for 3 or more days after adol or THIP (4,5,6,7 - tetrahydroisoxazolo ( 5,4 - c ) pyridin administration to the patient. No gaboxadol in any form is 3 -ol ) is a selective GABAA receptor agonist with a prefer administered to the patient for 3 or more days following the US 2020/0155522 A1 May 21 , 2020 2 first treatment after reaching a therapeutic effect threshold istration of the first treatment, and if the patient experiences based on one or more clinical biomarkers , such as EEG or a recurrence of the risk of suicide and / or depressive symp blood level of gaboxadol. toms, administering an additional treatment of gaboxadol, or [0010 ] The first treatment of gaboxadol comprises an pharmaceutically acceptable
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