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ZAFGEN INC

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Patent Application Titled “Methods Of Treating An Overweight Or Obese Subject” Published Online (USPTO 20190224156): Zafgen Inc.

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08/14/2019 | 05:43pm EDT

2019 AUG 14 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity Daily News -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Hughes, Thomas E. (Boston, MA); Vath, James E. (Lynnfield, MA), filed on August 27, 2018, was made available online on July 25, 2019.

The assignee for this patent application is Zafgen Inc. (Boston, Massachusetts, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “Obesity is a complex medical disorder of appetite regulation and metabolism resulting in excessive accumulation of adipose tissue mass. Typically defined as a body mass index (BMI) of 30 kg/m.sup.2 or more, obesity is a world-wide public health concern that is associated with cardiovascular disease, diabetes, certain cancers, respiratory complications, osteoarthritis, gallbladder disease, decreased life expectancy, and work disability. The primary goals of obesity therapy are to reduce excess body weight, improve or prevent obesity-related morbidity and mortality, and maintain long-term weight loss.

“Treatment modalities typically include lifestyle management, pharmacotherapy, and surgery. Treatment decisions are made based on severity of obesity, seriousness of associated medical conditions, patient risk status, and patient expectations. Notable improvements in cardiovascular risk and the incidence of diabetes have been observed with weight loss of 5-10% of body weight, supporting clinical guidelines for the treatment of obesity that recommend a target threshold of 10% reduction in body weight from baseline values.

“However, while prescription anti-obesity medications are typically considered for selected patients at increased medical risk because of their weight and for whom lifestyle modifications (diet restriction, physical activity, and behavior therapy) alone have failed to produce durable weight loss, approved drugs have had unsatisfactory efficacy for severely obese subjects, leading to only .about.3-5% reduction in body weight after a year of treatment.

“Bariatric surgery may be considered as a weight loss intervention for patients at or exceeding a BMI of 40 kg/m.sup.2. Patients with a BMI.gtoreq.35 kg/m.sup.2 and an associated serious medical condition are also candidates for this treatment option. Unfortunately, postoperative complications commonly result from bariatric surgical procedures, including bleeding, embolism or thrombosis, wound complications, deep infections, pulmonary complications, and gastrointestinal obstruction; reoperation during the postoperative period is sometimes necessary to address these complications. Rates of reoperation or conversion surgery beyond the postoperative period depend on the type of bariatric procedure, and in one study ranged from 17% to 31%. Intestinal absorptive abnormalities, such as micronutrient deficiency and protein-calorie malnutrition, also are typically seen with bypass procedures, requiring lifelong nutrient supplementation. Major and serious adverse outcomes associated with bariatric surgery are common, observed in approximately 4 percent of procedures performed (including death in 0.3 to 2 percent of all patients receiving laparoscopic banding or bypass surgeries, respectively)

“MetAP2 encodes a protein that functions at least in part by enzymatically removing the amino terminal methionine residue from certain newly translated proteins such as glyceraldehyde-3-phosphate dehydrogenase (Warder et al. (2008) J Proteome Res 7:4807). Increased expression of the MetAP2 gene has been historically associated with various forms of cancer. Molecules inhibiting the enzymatic activity of MetAP2 have been identified and have been explored for their utility in the treatment of various tumor types (Wang et al. (2003) Cancer Res. 63:7861) and infectious diseases such as microsporidiosis, leishmaniasis, and malaria (Zhang et al. (2002) J. Biomed. Sci. 9:34). However, such MetAP2 inhibitors may be useful as well for patients with excess adiposity and conditions related to adiposity including type 2 diabetes, hepatic steatosis, and cardiovascular disease (via e.g. ameliorating insulin resistance, reducing hepatic lipid content, and reducing cardiac workload). Methods of treating obese subjects that are more effective than e.g. dieting alone are clearly needed.”

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors’ summary information for this patent application: “This disclosure generally relates to methods of treating an overweight or obese subject or patient that include non-parenterally administering a pharmaceutically effective amount of a MetAP2 inhibitor to a patient in need thereof, e.g., a human or a companion animal such as a cat or a dog.

“In one embodiment, a method of treating obesity in a patient in need thereof is provided, comprising non-parenterally administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient. Such methods may result in, for example, a lower systemic exposure to said MetAP2 inhibitor as compared to a patient parenterally administered the same of amount of the MetAP2 inhibitor. Contemplated pharmaceutically effective amounts may not substantially modulate or suppress angiogenesis. In exemplary embodiments, non-parenteral administration may result in decreased body fat and a substantial maintenance of muscle mass in said patient. Such methods may enhance fat oxidation compared to a patient on a restricted food intake diet alone. Also provided herein is a method of treating obesity in a patient in need thereof, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient, wherein substantially no loss of new blood vessels in fat deposits occur as compared to a patient being treated for obesity using an energy restricted diet alone. In some embodiments, non-parenterally administration may include oral, buccal, sublingual, transdermal, rectal, nasal administration, or administration via inhalation.

“Contemplated MetAP2 inhibitors include substantially irreversible inhibitors, such as e.g., fumagillin, fumagillol or fumagillin ketone derivative, siRNA, shRNA, an antibody, or a antisense compound, or, e.g., O-(4-dimethylaminoethoxycinnamoyl)fumagillol and pharmaceutically acceptable salts thereof. In another embodiment, a contemplated MetAP2 inhibitor may be substantially reversible inhibitor.

“Also provided herein is a method for controlling or preventing hepatic steatosis in an obese patient being treated for obesity, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient, and/or a method for improving liver function in an obese patient, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient.

“In an embodiment, a method of improving exercise capacity in a patient in need thereof is provided that includes administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient.

“A method of reducing weight of a patient in a patient in need thereof is contemplated herein that comprises administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient wherein the metabolic rate of the patient is not substantially reduced as compared to the metabolic rate of a diet only patient on an energy restricted diet alone. Also provided herein is a method of restoring normal metabolic action in an obese patient in need thereof, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient.

“In an embodiment, a method of decreasing body fat in an overweight or obese patient in need thereof is provided that comprises administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient resulting in body fat reduction, and wherein said patient substantially maintains muscle mass during the body fat reduction, for example a patient may retain substantially more muscle mass as compared to body fat reduction in a patient using an energy restricted diet alone.

“A method of activating brown fat function and/or increasing brown fat tissue mass in a patient in need thereof is provided, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient, and/or a method of restoring and/or maintaining thyroid hormone concentrations in an obese patient, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient.

“The disclosed methods may include a pharmaceutically effective amount of a MetAP2 inhibitor that does not substantially modulate or suppress angiogenesis in a treated patient. In some embodiments of the disclosed methods, a patient has a lower systemic exposure to said MetAP2 inhibitor as compared to a patient parenterally administered the same amount of the MetAP2 inhibitor.

“MetAP2 inhibitors may be administered non-parenterally, orally buccally or sublingually, topically, rectally, or transdermally in at least some disclosed methods. In some disclosed methods, a MetAP2 inhibitor may be administered subcutaneously or intravenously. In some embodiments, administration of a MetAP2 inhibitor may occur at least daily, or every other day, or at least weekly.

“Also contemplated herein is a method for reducing the amount or frequency of administering supplemental insulin in a patient suffering from type 2 diabetes, comprising a pharmaceutically effective amount of a MetAP2 inhibitor.

“A method for improving surgical outcome in an obese patient in need thereof, by reducing weight of said patient is provided herein, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient before non-acute surgery, thereby reducing liver and/or abdominal fat in said patient and improving surgical outcome. Such surgeries may include e.g., bariatric surgery, cardiovascular surgery, abdominal surgery, or orthopedic surgery. Also provided herein is a method of maintaining a specified weight in a formerly obese patient, comprising administering a pharmaceutically effective amount of a MetAP2 inhibitor to said patient.

“Disclosed methods may further comprise co-administering an additional weight loss agent and/or may further comprise administering a food restricted diet to a patient. In another embodiment, a disclosed method may further comprise assessing the ketone body production level in a patient; and optionally adjusting the amount administered; thereby optimizing the therapeutic efficacy of said MetAP2 inhibitor. In at least some disclosed methods, a patient may incur greater than or about equal to a 20% weight loss after about 6 months of said administration.

“In another embodiment, a method for treating obesity in a patient in need thereof is provided, comprising administering about 0.005 to about 0.04 mg/kg of a MetAP2 inhibitor selected from O-(4-dimethylaminoethoxycinnamoyl)fumagillol and pharmaceutically acceptable salts thereof, for example, an oxalate salt, to said patient. This MetAP2 inhibitor may be administered at least daily, or 1, 2, 3 or 4 times a week. In some embodiments, MetAP2 may be administered parenterally, e.g., intravenously, or non-parenterally. Upon administration of the MetAP2 inhibitor e.g. daily, or 1, 2, 3, 4, 5, 6 or 7 times a week, for about 6 months, may result in at least a 20% weight loss or more of the patient’s original weight.”

The claims supplied by the inventors are:

“1.-50. (canceled)

“51. A method for treating obesity in a human patient in need thereof, comprising subcutaneously administering about 0.005 to about 0.049 mg/kg, 1, 2 or 3 times a week, of a MetAP2 inhibitor selected from O-(4-dimethylaminoethoxycinnamoyl)fumagillol and pharmaceutically acceptable salts thereof, to said patient.

“52. The method of claim 51, wherein the MetAP2 inhibitor is an oxalate salt of O-(4-dimethylaminoethoxycinnamoyl)fumagillol.

“53. (canceled)

“54. The method of claim 51, wherein said administering occurs 1 or 2 times a week.

“55.-57. (canceled)

“58. The method of claim 54, wherein said administering occurs 2 times a week.

“59. The method of claim 54, wherein said administering occurs once a week.”

For more information, see this patent application: Hughes, Thomas E.; Vath, James E. Methods Of Treating An Overweight Or Obese Subject. Filed August 27, 2018 and posted July 25, 2019. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190224156%22.PGNR.&OS=DN/20190224156&RS=DN/20190224156

(Our reports deliver fact-based news of research and discoveries from around the world.)

Copyright © 2019 NewsRx LLC, Obesity Daily News, source Health Newsletters

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