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(12) Patent Application Publication (10) Pub. No.: US 2016/0243117 A1 MENON (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2016/0243117 A1 MENON (43) Pub US 20160243117A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0243117 A1 MENON (43) Pub. Date: Aug. 25, 2016 (54) HOST DEFENSE PROTEIN (HDP) MIMETICS Publication Classification FOR PROPHYLAXIS AND/OR TREATMENT OF INFLAMMATORY DISEASES OF THE (51) Int. Cl. GASTRONTESTINAL TRACT A613 L/506 (2006.01) A6II 45/06 (2006.01) (71) Applicant: CELLCEUTIX CORPORATION, A63/67 (2006.01) BEVERLY, MA (US) (52) U.S. Cl. CPC ............. A6 IK3I/506 (2013.01); A61 K3I/I67 (72) Inventor: Krishna MENON, Beverly, MA (US) (2013.01); A61K 45/06 (2013.01) (73) Assignee: CELLCEUTIX CORPORATION, BEVERLY, MA (US) (57) ABSTRACT (21) Appl. No.: 15/042.923 (22) Filed: Feb. 12, 2016 The present invention provides methods for treating and/or preventing inflammatory diseases of the gastrointestinal tract Related U.S. Application Data with one or more compounds, orpharmaceutically acceptable (60) Provisional application No. 62/118,950, filed on Feb. salts thereof, disclosed herein, and the use of compositions 20, 2015. comprising the same. Patent Application Publication Aug. 25, 2016 Sheet 1 of 15 US 2016/02431 17 A1 Figure : VX3.3 tilitic of EAB 3: .. 2. 5 10000 8.8 .. PVX30.063 Concentration iv) Patent Application Publication Aug. 25, 2016 Sheet 2 of 15 US 2016/02431 17 A1 Figare 2 PVX6S ribition of PE432 3: .. 25000 20000 15000 10000 5000 { . PVX6056 concestration iv Patent Application Publication Aug. 25, 2016 Sheet 3 of 15 US 2016/02431 17 A1 Figure 3 PVX363 inhibition of E3A 3 . 2 s: 10000 5000 PVX3063 concentration M Patent Application Publication Aug. 25, 2016 Sheet 4 of 15 US 2016/02431 17 A1 Figare 4 Patent Application Publication Aug. 25, 2016 Sheet 5 of 15 US 2016/02431 17 A1 Figare 5 isities of Sirties ratific with X33 1530 58 i.-- astreated iS3;gini. 0.33 3.38 3.8:8 32.38 32.8; 83883 SS3 8388 X3883 SS3 3. S S. 3. SS Patent Application Publication Aug. 25, 2016 Sheet 6 of 15 US 2016/02431 17 A1 Figare 6 inhiities at S-isitaced at Ni-- with XOS *Sitgifts 3.it E.S. 2.58. X8s 83. XSS -is s S. Patent Application Publication Aug. 25, 2016 Sheet 7 of 15 US 2016/02431 17 A1 Figre 7 isix:iiier of sixteexistic-3 with six3863 3888 . 388 200 8 . st:0 $3rtreatsci. i*Sigfossi. &i gig 3. Sis 2.5:g ex38883 PR8x3883 P88x3386.3 p88x38883 re-X38883 sts --SS s38. y:S SS Patent Application Publication Aug. 25, 2016 Sheet 8 of 15 US 2016/02431 17 A1 Figtre 8 inhibition of LPS-induced rat MCP-1 with PMX60056 0.7 0.6 0.5 .. 0.3 0.2 O - .k.a.k.a.k. .*.*.*.*.*.*.*.*.*.*.*.*...............................................................................................................................: iPSigfrn. .iig .xig 2.sg Xss Xss Xss -S S. S. Patent Application Publication Aug. 25, 2016 Sheet 9 of 15 US 2016/02431 17 A1 Figare 9 inhibition of iPS-induced at Wy-9 with Pyx30083 3.3.3.8, 3. 3. i. itrester PSigfari 8.3: 8.38: 2.38 32.88. 82.58: 83883 F88333 x33883 pix33363. P.X3883 S. 3. -3 S. 3. Patent Application Publication Aug. 25, 2016 Sheet 10 of 15 US 2016/02431 17 A1 Figare it hiitic of Sidiceti rat is with X303 1408 i200 808 - 8.- :---------------------------- s ... 8.................&....... untreated irgini is 8,ight &S R 2.8.8 i3.38 83.388 p8x38883 88.3883 388x383 8383 $383 PS S. S. S 3. Patent Application Publication Aug. 25, 2016 Sheet 11 of 15 US 2016/02431 17 A1 Figure is to --vi-5mg/kg --PO-0mg/kg 4. 8 2 8 2 24 ineff) Patent Application Publication Aug. 25, 2016 Sheet 12 of 15 US 2016/02431 17 A1 Figare 2. 1 OOOO OOOO 000 O Patent Application Publication Aug. 25, 2016 Sheet 13 of 15 US 2016/02431 17 A1 Figs re 3 Timehr Patent Application Publication Aug. 25, 2016 Sheet 14 of 15 US 2016/02431 17 A1 Figure 4 intestine weight 8:3: 3. 3. 3.ss: intreated 88 riskg 38 regfkg it regfxg SeáSk X3883 X38. S3 Patent Application Publication Aug. 25, 2016 Sheet 15 of 15 US 2016/02431 17 A1 Figure i5 Ulcerative colitis score 3.0 ; 2.5 2.0 1.5 1.0 0.5 treate 200 mg/kg 400 mg/kg SASA X3883 X38 X383 US 2016/02431 17 A1 Aug. 25, 2016 HOST DEFENSE PROTEIN (HDP) MIMETICS abdominal cramps and pain, and an inability to move the FOR PROPHYLAXIS AND/OR TREATMENT bowels in spite of the urge to do so (tenesmus). OF INFLAMMATORY DISEASES OF THE 0008 Left-sided colitis—Inflammation extends from GASTRONTESTINAL TRACT the rectum up through the sigmoid and descending colon. Signs and symptoms include bloody diarrhea, CROSS REFERENCE APPLICATION abdominal cramping and pain on the left side, and unin 0001. This application claims the benefit of U.S. Provi tended weight loss. sional Application 62/118,950 filed Feb. 20, 2015, and incor 0009 Pancolitis Pancolitis often affects the entire porates the same by reference. colon and causes bouts of bloody diarrhea that may be 0002 The present invention relates to the use of host severe, abdominal cramps and pain, fatigue, and signifi defense protein (HDP) mimetics, including brilacidin (PMX cant weight loss. 30063) and delparantag (PMX-60056), and the pharmaceu 0.010 Acute severe ulcerative colitis—Previously tically acceptable salts thereof, and pharmaceutical compo called fulminant colitis, this rare form of colitis affects sitions thereof in preventing and treating inflammatory the entire colon and causes severe pain, profuse diarrhea, diseases of the gastrointestinal tract. bleeding, fever and inability to eat. 0011 Collagenous colitis and lymphocytic colitis also are BACKGROUND OF THE INVENTION considered inflammatory bowel diseases but are usually regarded separately from classic inflammatory bowel disease. 0003 Inflammatory diseases of the gastrointestinal tract 0012 Crohn's disease is also an inflammatory bowel dis involves chronic inflammation of all or part of the digestive ease that causes inflammation of the lining of the digestive tract. Inflammatory diseases of the gastrointestinal tract is not tract. In Crohn's disease, inflammation often spreads deep a single disorder. It is the term for a group of disorders that into affected tissues. The inflammation can involve different cause prolonged inflammation of the digestive tract. Such a areas of the digestive tract—the large intestine, Small intes condition can be chronic, Sub-chronic or acute and can be tine or both. Three major patterns of disease distribution are mild, moderate or severe according to the condition. Many ileocecal (40%), small intestine (30%) and colon (25%). It is diseases are included in this umbrella term. The inflammation much less common to have involvement of the esophagus, of the digestive tract in all parts of the digestive tract, irre stomach and duodenum. The most common symptoms are spective of the anatomical area is included in this treatment. diarrhea, abdominal pain and weight loss. The disease is often The main symptom of active disease is usually constant diar present for months or years prior to diagnosis. In children, rhea mixed with blood, of gradual onset. growth retardation may be one of major sign of indication of 0004. The digestive tract is composed of the mouth, disease. The presence of fistula, abscess and fissures, which esophagus, stomach, Small intestine, large intestine, colon, are commonly called as perianal disease is a distinguishing rectum, and anus. It is responsible for breaking down food, factor from ulcerative colitis. Crohn's disease is also a remit extracting the nutrients, and removing any unusable material ting and relapsing disease like ulcerative colitis: more than and waste products. Inflammation anywhere along the diges 60% of patients will require surgery within 10 years, 70% of tive tract is included in this treatment process. The treatment patients will have endoscopic recurrence within one year of includes all these conditions: Surgery, and 50% of patients will have symptomatic recur 0005 Ulcerative colitis (UC) is an inflammatory bowel rence within 4 years. In Crohn's disease, the inflammation is disease (IBD) that causes long-lasting inflammation and more commonly focal, which leads to bowel wall thickening, Sores (ulcers) in the innermost lining of the large intestine becoming edematous and fibrotic, and the mesentery may (colon) and rectum. The predominant symptom is diarrhea, become infiltrated with fat. The major complications of are associated with blood in the stool, occasionally with fever and Stenosis, extensive ileal disease, extensive mucosal damage, abdominal pain. The onset may be insidious or acute (mild fistulae, urinary calcium oxalate Stones and carcinoma, while 60%, moderate to severe-25%, fulminant-15%). A severe massive hemorrhage is less common. Crohn's disease may attack may be accompanied by dilation of the colon, known as involve inflammation in different parts of the digestive tract in toxic megacolon, which is associated with significant mor different people. The most common areas affected are the last bidity and mortality. The complications of ulcerative colitis part of the Small intestine (ileum) and the colon. Inflammation are massive hemorrhage, stricture formation, fulminant coli may be confined to the bowel wall, which can lead to narrow tis (toxic megacolon) and colon cancer. Ulcerative colitis ing from inflammation or scarring or both (fibroStenosis), or begins in the rectum and may proceed proximally to involve may tunnel through the bowel wall (fistula). Narrowing may either a segment of colon or the entire colon: 60% to 75% of lead to a blockage (obstruction). Obstructions, Stenosis and ulcerative colitis patients have no disease proximal to the fistulas are not associated with ulcerative colitis. sigmoid. Pancolitis occurs in 20% of patients.
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