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(12) Patent Application Publication (10) Pub. No.: US 2010/0081713 A1 Sharma Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2010/0081713 A1 Sharma Et Al US 20100081713A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0081713 A1 Sharma et al. (43) Pub. Date: Apr. 1, 2010 (54) COMPOSITIONS AND METHODS FOR (22) Filed: Mar. 18, 2009 TREATINGVIRAL INFECTIONS Related U.S. Application Data (75) Inventors: Geeta Sharma, Singapore (SG); (60) Provisional application No. 61/069,917, filed on Mar. Ralf Altmeyer, Singapore (SG); 19, 2008. Vishal Pendharker, Singapore (SG); Yu Chen, Singapore (SG); Publication Classification Michael Foley, Chestnut Hill, MA (51) Int. Cl. (US) A63L/35 (2006.01) A6II 3L/25 (2006.01) Correspondence Address: A63L/35 (2006.01) Gearhart Law LLC A6II 3/13 (2006.01) 4 Femdale Avenue A6IP3L/2 (2006.01) Chatham, NJ 07928 (US) (52) U.S. Cl. .......... 514/459; 514/529; 514/647: 514/662 (73) Assignee: CombinatoRx, (Singapore) Pte. (57) ABSTRACT Ltd. The present invention provides compositions, methods, and kits for treating or preventing a viral infection (e.g., an infec (21) Appl. No.: 12/406,716 tion caused by an influenza virus). Patent Application Publication Apr. 1, 2010 Sheet 1 of 2 US 2010/0081713 A1 ------ 80 r -0. Vehicle 0.5% HPMC g - - Sertraline-30mg/kg/day - £ 60 “A Sertraline-100mg/kg/day/kg/day i -v. Oseltamivir-30mg/kg/day ...i -0. Oseltamivir-100mg/kg/day -0. (Sertraline 30mg/kg+ . 40 Prednisolone 0.1 mg/Kg) Figure 1 Patent Application Publication Apr. 1, 2010 Sheet 2 of 2 US 2010/0081713 A1 100 468OOO 2 O Wehicle Sentraline 10 mg/kg Sentraline 30mg/kg Setraline 100mg/kg Figure 2 US 2010/008 1713 A1 Apr. 1, 2010 COMPOSITIONS AND METHODS FOR TREATINGVIRAL INFECTIONS TABLE 1-continued CROSS-REFERENCE TO RELATED Desloratidine + Nortriptyline (e.g., HCI) Dipyridamole + Budesonide APPLICATIONS Dipyridamole + Ibudilast Epinastine + Prednisolone 0001. This application claims the benefit of U.S. Provi Nortriptyline (e.g., HCl) + Prednisolone sional Application No. 61/069,917, filed Mar. 19, 2008, Paroxetine (e.g., HCl) + Prednisolone which is hereby incorporated by reference. Paroxetine (e.g., HCl) + Dipyridamole Sertraline + Prednisolone BACKGROUND OF THE INVENTION 0002 The invention relates to treating viral infections 0005. In another aspect, the invention features a method Such as influenza. Diseases caused by viruses are major health for treating or preventing a viral infection in a patient. The problems worldwide, and include many potentially fatal or method includes administering to the Subject an amount of an disabilitating illnesses. Influenza virus, for example, affects SSRI sufficient to treat or prevent the viral infection in the 5-15% of the population during epidemics and causes upper patient. In certain embodiments, the patient has not been respiratory tract infections. Hospitalization and deaths can diagnosed with or does not suffer from depression, major occur, especially in high-risk groups (elderly, chronically ill depressive disorder, obsessive-compulsive disorder, panic and immuno-compromised). Between three and five million disorder, posttraumatic stress disorder, social anxiety disor cases of severe influenza and between 250,000 and 500,000 der, generalized anxiety disorder, or premenstrual dysphoric deaths are recorded every year around the world. Accord disorder. The SSRI may be selected from the group consisting ingly, there exists a need for reducing influenza and other viral of cericlamine, citalopram, clovoxamine, cyanodothiepin, infections. dapoxetine, escitalopram, femoxetine, fluoxetine, fluvoxam ine, ifoxetine, indalpine, indeloxazine, litoxetine, milnacip SUMMARY OF THE INVENTION ran, paroxetine, Sertraline, tametraline, Viqualine, and Zimel dine; or analog thereof. 0003) We have identified agents and combinations of 0006. In another aspect, the invention features a method agents which reduce inflammatory response in cells infected for treating or preventing a viral infection in a patient. The with an influenza virus, and further, have shown that agents method includes administering to the patient a combination and combinations of agents can reduce mortality rates of mice of agents selected from the group consisting of: infected with an influenza virus. On this basis, the present 0007 (a) a tricyclic antidepressant (e.g., amoxapine, invention provides compositions, methods, and kits useful in nortriptyline, or an analog thereof) and a corticosteroid (e.g., treating viral infections such as influenza. prednisolone, budesonide, or an analog thereof); 0004. Accordingly, in a first aspect, the invention features 0008 (b) an SSRI (e.g., sertraline, paroxetine, orananalog a composition comprising a combination of agents listed in thereof) and a corticosteroid (e.g., prednisolone, or an analog Table 1 (e.g., further in combination with an antiviral agent) thereof); or a combination of an SSRI with an antiviral agent. The SSRI 0009 (c) a tricyclic antidepressant (e.g., amoxapine, may be cericlamine, citalopram, clovoxamine, cyanodothi nortriptyline, or an analog thereof) and a tetra-substituted epin, dapoxetine, escitalopram, femoxetine, fluoxetine, flu pyrimidopyrimidine (e.g., dipyridamole, or an analog Voxamine, ifoxetine, indalpine, indeloxazine, litoxetine, mil thereof); nacipran, paroxetine, Sertraline, tametraline, Vicqualine, and 0010 (d) a corticosteroid (e.g., budesonide, or an analog Zimeldine; or analog thereof. In certain embodiments, the thereof); and a tetra-substituted pyrimidopyrimidine (e.g., SSRI is sertraline or an analog thereof. The antiviral agent dipyridamole, or an analog thereof); may be a Group A antiviral agent (e.g., oseltamivir, Zan 0011 (e) an SSRI (e.g., paroxetine, or an analog thereof) amivir, amantadine, and rimantadine). The agents may be and a tetraSubstituted pyrimidopyrimidine (e.g., dipy present in an amount Sufficient to treat a viral infection (e.g., ridamole, or an analog thereof); an influenza infection caused by any of the types, Subtypes, or 0012 (f) tetrasubstituted pyrimidopyrimidine (e.g., dipy strains described herein). The composition may be formu ridamole, or an analog thereof) and ibudilast, or analog lated for administration by any route known in the art such as thereof; oral, parenteral (e.g., intravenously or intramuscularly), rec 0013 (g) an antihistamine (e.g., epinastine, or an analog tal, determatological, cutaneous, nasal, vaginal, inhalant, skin thereof) and a corticosteroid (e.g., prednisolone, or an analog (patch), ocular, intrathecal, and intracranial. In certain thereof); embodiments the composition includes, consists of, or con 0014 (h) a corticosteroid (e.g., prednisolone, or an analog sists essentially of (a) a pair of agents shown in Table 1, or thereof) and bufexamac, or analog thereof; pharmaceutically acceptable salts thereof, and (b) a pharma 0015 (i) an antihistamine (e.g., desloratidine, oran analog ceutically acceptable carrier. thereof) and a non-steroidal immunophilin-dependent immu nosuppressant (NSIDI) (e.g., a cyclosporine); TABLE 1. 0016 () a tricyclic antidepressant (e.g., nortriptyline, or Amoxapine + Dipyridamole an analog thereof) and an antihistamine (e.g., desloratidine, Amoxapine + Prednisolone or an analog thereof); and Budesonide + Nortriptyline (e.g., HCI) Bufexamac + Prednisolone 0017 (k) an antihistamine (e.g., desloratidine, or an ana CME-Amoxapine + Prednisolone log thereof) and an SSRI (e.g., fluoxetine, or an analog Desloratidine + Cyclosporine thereof); Desloratidine + Fluoxetine where the two drugs are administered simultaneously or within 14 days of each other in amounts that together are US 2010/008 1713 A1 Apr. 1, 2010 sufficient to treat or prevent said viral infection in said patient. oid, a tetrasubstituted pyrimidopyrmidine, and an antihista The SSRI may be selected, for example, from the group mine to a patient for treating or preventing a viral infection. consisting of cericlamine, citalopram, clovoxamine, cyan 0030. Another kit includes (a) a corticosteroid; and (b) odothiepin, dapoxetine, escitalopram, femoxetine, fluoxet instructions for administering (a) with at least one of a tricy ine, fluvoxamine, ifoxetine, indalpine, indeloxazine, litoxet clic antidepressant, a tetraSubstituted pyrimidopyrmidine, an ine, milnacipran, paroxetine, Sertraline, tametraline, antihistamine, an SSRI, and bufeXamac or an analog thereof Vicqualine, and Zimeldine, or analog thereof. The tricyclic to a patient for treating or preventing a viral infection. antidepressant may be selected from the group consisting of 0031. Another kit includes (a) a tetrasubstituted pyrimi maprotiline, amoxapine, 8-hydroxyamoxapine, 7-hy dopyrmidine; and (b) instructions for administering (a) with droxyamoxapine, loxapine, loxapine Succinate, loxapine at least one of a corticosteroid, a tricyclic antidepressant, an hydrochloride, 8-hydroxyloxapine, amitriptyline, clomi SSRI, and ibudilast or an analog thereof to a patient for pramine, doxepin, imipramine, trimipramine, desipramine, treating or preventing a viral infection. nortriptyline, and protriptyline; or an analog thereof. 0032. Another kit includes (a) an antihistamine; and (b) 0018. In certain embodiments, the combination of agents instructions for administering (a) with at least one of a corti is selected from the combinations of Table 1, oracombination costeroid, an NSIDI, a tricyclicantidepressant, and an SSRI to including one or more analogs of the agents of Table 1. An a patient for treating or preventing a viral infection. agent may be administered by any route known in the art Such 0033. Another kit includes (a) ibudilast or an analog as oral, parenteral (e.g.,
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