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Tranzyme Pharma Announces Presentation of Additional Data for Its Oral Drug Candidate, TZP-102, at Annual Neurodiab Meeting in Porto, Portugal
Observed Effects of TZP-102 on Gastroparesis Symptoms Similar in Both Type 1 and Type 2 Diabetes Patients
RESEARCH TRIANGLE PARK, N.C. - September 12, 2011 - Tranzyme Pharma announced that Niels Ejskjaer, M.D., Ph.D., Department of Endocrinology M, Aarhus University Hospital, Denmark, presented additional data from Tranzyme's Phase 2, 28-day study of its oral ghrelin agonist, TZP-102, supporting its potential role in the treatment of gastroparesis in diabetic patients. The data were presented on September 11, 2011 at the annual Neurodiab Meeting held in Porto, Portugal.
Dr. Ejskjaer's presentation entitled "TZP-102 Ghrelin Agonist Improves Symptoms of Gastroparesis in Both Type 1 Type 2 Diabetic Patients: 28-Day Treatment Study Data" noted the following findings:
- Oral administration of TZP-102 for 28 days significantly improved gastroparesis symptoms;
- The observed effects were similar in type 1 and type 2 diabetic patients;
- TZP-102 was well tolerated with no impact on body weight or glucose control parameters; and
- Overall, TZP-102 represents a promising pharmacological option to address an unmet medical need for patients whose day-to-day life is impaired by gastroparesis.
Tranzyme plans to initiate a 12-week Phase 2b study of TZP-102 later this year.
Gastroparesis can be a manifestation of many systemic illnesses, arise as a complication of select surgical procedures or develop due to unknown causes. According to the American Motility Society Task Force on Gastroparesis in an article titled "Treatment of Gastroparesis: A Multidisciplinary Clinical Review," published in Neurogastroenterology and Motility in 2006, up to 4% of the population in the United States experiences symptomatic manifestations of gastroparesis. Any disease inducing neuromuscular dysfunction of the GI tract can result in gastroparesis, with diabetes being one of the leading known causes. In one study published in Current Gastroenterology Reports in 2007, it was reported that 29% of gastroparesis cases were found in association with diabetes (25% were type 1 diabetics and the remainder were type 2), 13% developed as a complication of surgery and 36% were due to unknown causes. As the incidence of diabetes rises worldwide, the prevalence of gastroparesis is expected to rise correspondingly.
About Tranzyme Pharma
Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 20 percent of adults worldwide are affected by these persistent and recurring conditions which disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options. Tranzyme is developing an intravenous drug, ulimorelin, for patients in acute (hospital-based) settings, as well as an oral drug (TZP-102) for chronic conditions. Ulimorelin is currently in Phase 3 clinical trials and TZP-102 is entering Phase 2b. Together these product candidates target a significant underserved market. By leveraging its proprietary drug discovery technology, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical needs.
Further information about Tranzyme Pharma can be found on the Company's web site at www.tranzyme.com.
The Tranzyme, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=9438
Statements in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section21E of the Securities Exchange Act, which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.These include statements regarding the expected timing of our Phase 2b study for TZP-102, and the potential for success of TZP-102 in treating gastroparesis in diabetic patients.We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section27A of the Securities Act and Section21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made.Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks related to enrollment and successful completion of our trials, risk of unforeseen side effects, risks related to our collaborations and risks related to regulatory approval of new drug candidates. Further information on these and other factors that could affect the company's financial results is contained in our public filings with the Securities and Exchange Commission (SEC) from time to time, including our Registration Statement on Form S-1 (Registration No. 333-170749), which was declared effective by the Securities and Exchange Commission on April 1, 2011, and subsequent filings with the SEC.Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.