Tranzyme Pharma Initiates Dosing in Phase 2b Trial of TZP-102 in Diabetic Patients With Gastroparesis
RESEARCH TRIANGLE PARK, N.C. – October 5, 2011 – Tranzyme Pharma announced that it has dosed its first patient in a Phase 2b, 12-week trial of its first-in-class, oral, gastrointestinal (GI) motility drug candidate, TZP-102. The trial will be conducted in patients suffering from diabetic gastroparesis, a chronic, often life-altering GI condition affecting both type 1 and type 2 diabetic patients. The Company expects to dose approximately 200 patients in the U.S. and Europe across three treatment arms: 10mg or 20mg doses of TZP-102 or placebo.
“Given the limited treatment options for the large population of people with diabetes suffering from gastroparesis, there is a critical need for a safe and effective treatment,” said Steven Cliff, M.D. of Arkansas Gastroenterology in Sherwood, AR, the first study site to begin enrollment. “Gastroparesis can cause serious complications and has the potential to exacerbate diabetes symptoms because it can lead to erratic digestion and fluctuating blood sugar levels. We are enthusiastic about the potential of TZP-102 as it could represent a significant advancement in the treatment of gastroparesis.”
TZP-102 represents a novel mechanism of action as it targets the ghrelin receptor, which plays a direct role in the stimulation of GI motility. TZP-102 is an orally-administered promotility agent in clinical development for the treatment of diabetic gastroparesis. Currently, there are no safe and effective treatments for gastroparesis. In recognition of this critical unmet need, the Food and Drug Administration (FDA) has granted TZP-102 Fast Track designation.
“We are very pleased that patient enrollment in the TZP-102 Phase 2b trial is underway according to plan,” said Vipin Garg, Ph.D., President and CEO, Tranzyme Pharma. “We remain committed to developing a safe and effective therapy that reduces the severity of symptoms and improves the daily lives of patients suffering from gastroparesis, as well as other GI motility disorders that impact millions of patients worldwide.”
The Phase 2b trial is a double-blind, multinational evaluation of two dose levels of TZP-102 and placebo administered orally, once daily, for 12 weeks in diabetic patients with a history of moderate to severe symptoms of gastroparesis. Study subjects will report symptom severity daily. Top-line data are expected by year-end 2012.
A 28-day Phase 2 trial of TZP-102 in this same patient population demonstrated statistically and clinically significant improvements for each of the most prevalent symptoms of gastroparesis: nausea, early satiety, bloating and upper abdominal pain. In addition, the results concluded TZP-102 was effective in both type 1 and type 2 diabetics, safe and well tolerated.
Gastroparesis can be a manifestation of many systemic illnesses, arise as a complication of 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 a study published in Current Gastroenterology Reports in 2007, it was reported that 29% of gastroparesis cases were found in association with diabetes, 13% developed as a complication of surgery, 22% were from miscellaneous origins 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. In addition to TZP-102, Tranzyme is developing an intravenous drug, ulimorelin, for patients in acute (hospital-based) settings. Ulimorelin is currently being evaluated in two Phase 3 pivotal trials. 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.
Statements in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section27A 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 timing, location and size of our Phase 2b trial for TZP-102 and related data, 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.