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WO 2013/057284 Al 25 April 2013 (25.04.2013) P O P C T

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WO 2013/057284 Al 25 April 2013 (25.04.2013) 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 2013/057284 Al 25 April 2013 (25.04.2013) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/202 (2006.01) A61P 17/00 (2006.01) kind of national protection available): AE, AG, AL, AM, A61P 17/10 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) International Application Number: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/EP20 12/070809 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 19 October 2012 (19.10.2012) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/549,018 19 October 201 1 (19. 10.201 1) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant: DIGNITY SCIENCES LIMITED [IE/IE]; GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, First Floor, Block 3, The Oval Shelbourne Road Balls - UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, bridge, Dublin, 44245 (IE). TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, LT, LU, LV, (72) Inventors: CLIMAX, John; Dignity Sciences Limited, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, First Floor, Block 3, The Oval Shelbourne Road, Balls- TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, bridge, Dublin, 44245 (IE). COUGHLAN, David; Dignity ML, MR, NE, SN, TD, TG). Sciences Limited, First Floor, Block 3, The Oval Shel bourne Road, Ballsbridge, Dublin, 44245 (IE). MANKU, Published: Mehar; Dignity Sciences Limited, First Floor, Block 3, — with international search report (Art. 21(3)) The Oval Shellbourne Road, Ballsbridge, Dublin 44245 (GB). (74) Agent: WAKERLEY, Helen; Reddie & Grose LLP, 16 Theobalds Road, London Greater London WC1X 8PL (GB). (54) Title: PHARMACEUTICAL COMPOSITIONS COMPRISING DGLA, 15-OHEPA, AND/OR 15-HETRE AND METHODS OF USE THEREOF (57) Abstract: The present disclosure provides compositions comprising fatty acids, or derivatives thereof (e.g. , C1-C4 esters) in cluding, for example, DGLA, 15-OHEPA and/or 15-HETrE, used singly or in combination with anti-bacterial agents for the treat ment of disease and/or disorders such as acne or atopic dermatitis. TITLE PHARMACEUTICAL COMPOSITIONS COMPRISING DGLA, 15-OHEPA, AND/OR 15-HETRE AND METHODS OF USE THEREOF FIELD [0001] The disclosure generally relates to compositions comprising fatty acids including, for example, DGLA, 15-OHEPA and/or 15-HETrE for the treatment of disease and/or disorders such as acne or atopic dermatitis. BACKGROUND [0002] There are over a dozen subtypes of acne. Most types of acne are caused by environmental exposure, chemical exposure, physical trauma or abrasion of the skin, or sensitivity to hormone levels. One type, acne vulgaris, and related forms of acne including, for example, acne necrotica, has been linked to bacterial infection by Propionibacterium acnes. Presently, there exist numerous regimens for the treatment of acne including topical application of creams comprising benzoyl peroxide. However, such creams are not always effective at reducing the growth of bacteria and ameliorating the clinical manifestation of the condition. Additionally, current regimens are limited in dose strength due to side effects. Accordingly, there exists a need for compositions that are more effective in the treatment of acne. SUMMARY [0003] The present disclosure provides compositions comprising fatty acids agents including, for example, DGLA, 15-OHEPA and/or 15-HETrE, used singly, in combination and/or in combination with anti-bacterial agents for the treatment of disease and/or disorders such as acne or atopic dermatitis. [0004] The present disclosure also provides methods for treating or preventing acne in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of DGLA, 15-OHEPA, or 15- HETrE or combinations thereof. In some embodiments, the pharmaceutical composition comprises about 0.1 wt.% to about 20 wt.% of DGLA, 15-OHEPA, or 15-HETrE. [0005] In some embodiments, the pharmaceutical composition comprises one or more pharmaceutically acceptable excipients. [0006] In some embodiments, the pharmaceutical composition comprising DGLA further includes a therapeutically effective amount of benzoyl peroxide. In some embodiments, the pharmaceutical composition comprises about 1.25% to about 10 wt.% of benzoyl peroxide. [0007] In some embodiments, the pharmaceutical composition comprising 15-OHEPA further includes a therapeutically effective amount of benzoyl peroxide. In some embodiments, the pharmaceutical composition comprises about 1.25% to about 10 wt.% of benzoyl peroxide. [0008] In some embodiments, the pharmaceutical composition comprising 15-HETrE further includes a therapeutically effective amount of adapalene. In some embodiments, the pharmaceutical composition comprises about 0.05% to about 0.3 wt.% of adapalene. [0009] In some embodiments, the step of administering comprises topically applying the composition to an area of the skin afflicted with acne lesions. In some embodiments, the area of the skin afflicted with acne lesions is washed prior to application of the pharmaceutical composition. In some embodiments, the acne lesions are inflammatory type and/or non-inflammatory type lesions. [0010] In some embodiments, applying the composition results in about a 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or more reduction in number of acne lesions. [0011] In some embodiments, the acne is associated with Propionibacterium acnes. [0012] In some embodiments, the pharmaceutical composition is administered to the subject once a day, twice a day, or three times a day. [0013] In some embodiments, the pharmaceutical composition is a cream , lotion, gel or emulsion. [0014] In some embodiments, the subject previously exhibited acne lesions. [0015] The present disclosure also provides methods of treating or preventing acne vulgaris or acne necrotica or acne rosacea in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of DGLA. In some embodiments, the pharmaceutical composition comprises about 0.1% to about 20 wt.% of DGLA. [0016] In some embodiments, the pharmaceutical composition comprising DGLA further includes a therapeutically effective amount of benzoyl peroxide. In some embodiments, the pharmaceutical composition comprises about 1.25% to about 10 wt.% of benzoyl peroxide. [0017] In some embodiments, the step of administering comprises topically applying the composition to an area of the skin afflicted with acne lesions. In some embodiments, the area of the skin afflicted with acne lesions is first washed prior to application of the pharmaceutical composition. [0018] In some embodiments, the acne lesions are inflammatory type and/or non inflammatory type lesions. [0019] In some embodiments, the composition reduces about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or more of the acne lesions. [0020] In some embodiments, the acne is associated with Propionibacterium acnes. [0021] In some embodiments, the pharmaceutical composition is administered to the subject once a day, twice a day, or three times a day. [0022] In some embodiments, the pharmaceutical composition is a cream, lotion, gel or emulsion. [0023] In some embodiments, the subject previously exhibited acne lesions. [0024] The present disclosure also provides compositions for use in treating acne comprising a therapeutically effective amount of DGLA, 15-OHEPA, or 15-HETrE. In some embodiments, the composition comprises about 0.1% to about 20 wt.% of DGLA, 15-OHEPA, or 15-HETrE. [0025] In some embodiments, the composition comprising DGLA further includes a therapeutically effective amount of benzoyl peroxide. In some embodiments, the composition comprises about 1.25% to about 10 wt.% of benzoyl peroxide. [0026] In some embodiments, the pharmaceutical composition comprising 15-OHEPA further includes a therapeutically effective amount of benzoyl peroxide. In some embodiments, the pharmaceutical composition comprises about 1.25% to about 10 wt.% of benzoyl peroxide. [0027] In some embodiments, the pharmaceutical composition comprising 15-HETrE further includes a therapeutically effective amount of adapalene. In some embodiments, the pharmaceutical composition comprises about 0.05% to about 0.3 wt.% of adapalene. [0028] The present disclosure also provides methods for improving the antimicrobial activity of an agent used in the treatment of acne comprising adding a composition comprising one or more of DGLA, 15-OHEPA, or 15-HETrE to the agent. In some embodiments, the composition comprises about 0.1% to about 20 wt.% of DGLA, 15- OHEPA, or 15-HETrE. [0029] In some embodiments, the composition comprising DGLA further includes a therapeutically effective amount of benzoyl peroxide. In some embodiments, the composition comprises about 1.25% to about 10 wt.% of benzoyl
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