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WO 2012/125941 Al 20 September 2012 (20.09.2012) P O P C T

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WO 2012/125941 Al 20 September 2012 (20.09.2012) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2012/125941 Al 20 September 2012 (20.09.2012) P O P C T (51) International Patent Classification: (US). JU, William, D. [US/US]; 435 Bernardsville Road, A 59/22 (2006.01) Mendham, NJ 07945 (US). KELLOGG, Scott, C. [US/US]; PO Box 1773, Mattapoisett, MA 02739 (US). (21) International Application Number: PROUTY, Stephen, M. [US/US]; 236 Windsor Way, PCT/US20 12/029475 Doylestown, PA 18901 (US). SCHWEIGER, Eric (22) International Filing Date: [US/US]; 166 East 34th Street, #10B, New York, NY 16 March 2012 (16.03.2012) 10016 (US). LEDERMAN, Seth [US/US]; 200 E. 72nd Street - 35k, New York, NY 10021 (US). OSBAKKEN, English (25) Filing Language: Mary [US/US]; 29 W. Walnut Lane, Suite 300, Phil (26) Publication Language: English adelphia, PA 19144 (US). SCHINAZI, Alan, D. [US/US]; 129 Butler Avenue, Providence, RI 02906 (US). (30) Priority Data: 61/453,895 17 March 201 1 (17.03.201 1) US (74) Agents: CORUZZI, Laura, A. et al; Jones Day, 222 East 61/453,902 17 March 201 1 (17.03.201 1) US 41st Street, New York, NY 10017-6702 (US). 61/453,848 17 March 201 1 (17.03.201 1) US (81) Designated States (unless otherwise indicated, for every 61/453,746 17 March 201 1 (17.03.201 1) US kind of national protection available): AE, AG, AL, AM, 61/5 13,906 1 August 201 1 (01.08.201 1) US AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, 61/525,589 19 August 201 1 (19.08.201 1) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, 61/534,156 13 September 201 1 (13.09.201 1) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 61/590,937 26 January 2012 (26.01.2012) US HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, (71) Applicant (for all designated States except US): FOL- KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, LICA, INC. [US/US]; 88 East Main Street, Suite H-501, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Mendham, NJ 07945 (US). OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, (72) Inventors; and TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (75) Inventors/ Applicants (for US only): BARMAN, Shikha, P. [US/US]; 2 Bonnievale Drive, Bedford, MA 01730 [Continued on nextpage] (54) Title: LITHIUM TREATMENT FOR MICROBIAL INFECTIONS Lithium Gluconate Lithium Succinate Lithium Ca bo ate Microorganisms Fig. 1 (57) Abstract: The invention relates to lithium treatments for treating microbial infections in human subjects. Uses of compositions containing compounds that liberate lithium ions are described, including adjuvants and devices for administration. The lithium treat - ment(s) can be used in combination with other treatments, such as mupirocin, for treating microbial infections. The combination treatment(s) may be administered concurrently with, or before and/or after the lithium treatment. The invention also relates to lithium treatments for scar revision and wound healing in human subjects. The invention also relates to dermabrasion treatments for skin conditions and novel dermabrasion tips for carrying out such treatments. w o 2012/125941 A i III II II 11 I Illlll 11III III lllll lllll lllll lllll lllll 11 llll 11llll (84) Designated States (unless otherwise indicated, for every SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, kind of regional protection available): ARIPO (BW, GH, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, Published: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, — with international search report (Art. 21(3)) 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, LITHIUM TREATMENT FOR MICROBIAL INFECTIONS Cross-Reference to Related Applications [0001] This application claims priority to U.S. Provisional Patent Application No. 61/453,895, filed March 17, 201 1, U.S. Provisional Patent Application No. 61/453,848, filed March 17, 201 1, U.S. Provisional Patent Application No. 61/453,746, filed March 17, 201 1, U.S. Provisional Patent Application No. 61/453,902, filed March 17, 201 1, U.S. Provisional Patent Application No. 61/513,906, filed August 1, 201 1, U.S. Provisional Patent Application No. 61/525,589, filed August 19, 201 1, U.S. Provisional Patent Application No. 61/534,156, filed September 13, 201 1, and U.S. Provisional Patent Application No. 61/590,937, filed January 26, 2012, each of which is hereby incorporated by reference in its entirety. 1. INTRODUCTION [0002] The invention relates to lithium treatments for microbial infections and for colonization by microbes in human subjects. Compositions containing compounds that liberate lithium ions are described, including formulations comprising lithium carbonate for topical administration. The lithium treatment(s) can be used in combination with other treatments for microbial infections and for reduction of colonization by microbes. [0003] The invention also relates to lithium treatments for scar revision and wound healing in human subjects. The lithium treatments may be administered as a single pulse treatment or intermittently. Compositions containing compounds that liberate lithium ions are described, including formulations comprising lithium carbonate for topical administration. Uses of compositions containing compounds that liberate lithium ions are described, including adjuvants and devices for administration. The lithium treatment(s) can be administered via a drug sprayer device. The lithium treatment(s) can be used in combination with other treatments for scar revision, wound healing, or for hair growth or hair development and follicle neogenesis. Such combination treatments may involve mechanical or physical treatments that modulate scar revision or wound healing, or that cause integumental perturbation (e.g. such as laser, surgical treatments, including skin graft or full thickness wounding, or dermabrasion, dermatome planing, etc.); and/or chemical treatments that modulate wound healing, scar revision, or hair growth or hair follicle development, or that cause integumental perturbation or immune stimulation (e.g., such as adjuvants, antigens, cytokines, growth factors, etc.) for the treatment of wounds or revision of scars. The combination treatment(s) may be administered concurrently with, or during the "holidays" between, cycles of intermittent lithium treatments; or concurrently with, or before and/or after the pulse lithium treatment. [0004] The embodiments of the present invention also involve mechanical or physical treatments that cause integumental perturbation (e.g., dermabrasion) which may be used as part of a treatment for modulating hair growth in human subjects. Additionally, the embodiments of the present invention may involve mechanical or physical treatments that cause dermabrasion which may be used as part of a treatment for different skin conditions. 2. BACKGROUND [0005] The skin usually provides a remarkably good barrier against pathogenic microorganisms, such as pathogenic bacteria and fungi. The skin is colonized with resident bacterial flora. Although these bacteria are mostly non-pathogenic, colonization with potential pathogens also occurs, such as with Staphylococcus aureus, including methicillin- resistant strains. Although many microbes come in contact with or reside on the skin, they are normally unable to establish an infection. Cutaneous microbial infections often arise when there is a break in the continuity of the skin because the skin is torn, cut, or punctured, resulting in a wound. Microbial infections can also arise as a part of systemic infection. [0006] Bacterial infections can be caused by several types of bacteria, including Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Propionibacterium acnes, Staphylococcus epidermidis, Acinetobacter baumannii, Klebsiella pneumoniae, Enterobacter cloacae, Streptococcus pyogenes, corynebacterium species, enterococci, Proteus mirabilis, group D streptococci, other gram-positive aerobes, and Bacteroides fragilis. The most common anti-bacterial agents prescribed to patients with bacterial infections are antibiotics. However, infections caused by antibiotic resistant strains have become a global problem. The increasing prevalence of multi-drug resistant organisms with few or no treatment options such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE), multidrug-resistant Acinetobacter baumanni, and the extended spectrum beta-lactamase (ESBL) producing Gram-negative bacilli are a serious cause for concern. Thus, there is an urgent need for improved therapies to treat bacterial infections. [0007] Mycosis is a condition in which fungi pass the resistance barriers of the human or animal body and establish infections. Superficial mycoses are limited to the outermost layers of the skin and hair. Cutaneous mycoses extend deeper into the epidermis, and also include invasive hair and nail diseases. Anti-fungal agents that are currently used to treat cutaneous fungal infections include imidazoles, polyenes, thiocarbamates, ciclopirox, terbinafme, amorolfine, undecylenic alkanolamide and griseofulvin. Cutaneous fungal infections can be persistent and can often reoccur. Thus there is a need for alternative treatments to effectively and safely treat fungal infections, including novel topical treatments for conditions where current therapies generally require systemic administration (e.g. onychomycosis and tinea capitis). [0008] Microbial biofilms are increasingly being implicated in the failure of antimicrobial agents to treat wound infections, which leads to delayed healing. The presence of biofilms in various types of wounds has been shown directly by microscopic evaluation, revealing biofilms to consist of bacteria, fungi and mixed-species biofilms. Several studies have shown that organisms in biofilms act synergistically, modulating the action of antimicrobial agents and other toxins, improving survival of organisms in various situations.
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