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Evoke Pharma, Inc. Initiates Phase 2b Metoclopramide Intranasal Trial (MINT) in Patients With Diabetic Gastroparesis


5/5/2009 12:01:05 PM

SAN DIEGO, May 5 /PRNewswire/ -- - Evoke Pharma, Inc., a privately-held specialty pharmaceutical company, announced today that it has initiated a Phase 2b clinical trial to evaluate EVK-001 for the treatment of adults with symptoms of diabetic gastroparesis. Gastroparesis is a syndrome characterized by delayed emptying of the stomach into the intestine following a meal in the absence of mechanical obstruction. Diabetes is an important cause of gastroparesis, but other identified causes include previous abdominal surgery, neurologic conditions, and infection. Symptoms associated with gastroparesis include: fullness after eating a small amount of food, nausea, vomiting, and bloating. In addition to diminished quality of life for all sufferers, gastroparesis symptoms increase a diabetic patient's risk of life-threatening complications from malnutrition and erratic blood sugars.

The Metoclopramide Intranasal Trial (MINT) is expected to enroll approximately 225 adult patients with diabetic gastroparesis at more than 25 clinical sites in the United States. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of two doses of EVK-001 over four weeks. The severity of symptoms associated with diabetic gastroparesis and the impact of gastroparesis on quality of life will be evaluated before and after EVK-001 administration.

EVK-001 is a proprietary formulation of metoclopramide that has been optimized for intranasal delivery and tolerability. Unlike tablet formulations, EVK-001 is designed to deliver a systemic dose of metoclopramide that does not depend on absorption from the gastrointestinal (GI) tract.

"Given the significant clinical need and the limited treatments available, we recognize the importance of continuing to work closely with the Food and Drug Administration (FDA) to bring the product to the market as soon as possible," states Dave Gonyer, R.Ph., Chief Executive Officer of Evoke Pharma, Inc. "Encouraging results from previous studies with intranasal and marketed oral formulations of metoclopramide served as the basis for the company's decision to conduct MINT, prior to initiating a confirmatory Phase 3 study."

About Gastroparesis

Gastroparesis is a common GI problem affecting approximately 8 million Americans. The syndrome refers to delayed gastric emptying, in the absence of mechanical obstruction of the stomach, and is associated with a variety of symptoms. Patients with gastroparesis may experience symptoms of: postprandial fullness, nausea, vomiting, particularly vomiting of food ingested several hours previously, upper abdominal distention (bloating), early satiety, and anorexia. Severe symptoms may result in poor nutrition and dehydration resulting in hospitalization.

About Evoke Pharma, Inc.

Evoke Pharma, Inc. is a privately held, specialty pharmaceutical company headquartered in San Diego, CA focused on acquiring and developing products to treat GI disorders and diseases. Evoke's lead product, EVK-001, is currently in Phase 2b for the treatment of the symptoms associated with diabetic gastroparesis. The management team has an established track record of building successful specialty pharmaceutical companies. The company completed a $12 million Series A financing from Domain Associates and Latterell Venture Partners. Evoke holds rights to intellectual property associated with EVK-001 granted by the United States Patent & Trademark Office with expiration dates through 2021.

Further information regarding Evoke is available at www.EvokePharma.com.

Forward-Looking Statements

Evoke Pharma cautions that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Evoke Pharma that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Evoke Pharma's business including, without limitation, statements about: difficulties or delays in developing, obtaining regulatory approval, manufacturing and commercializing its products; unexpected performance of side effects of its products that could delay or prevent development or commercialization; the scope and validity of patent protection for its products; competition form other pharmaceutical companies; and its ability to obtain additional financing to support is operations. All forward-looking statements are qualified in their entirety by this cautionary statement and Evoke Pharma undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

CONTACT: Matt D'Onofrio, EVP, Corporate Development of Evoke Pharma, Inc.,
+1-858-967-5454

Web site: http://www.EvokePharma.com/


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