Tranzyme Pharma Announces Positive Results from Phase 2 Study of Oral TZP-102 (Ghrelin Agonist) in Patients with Diabetic GastroparesisStatistically Significant Results at Multiple Dose Levels with Sustained Effect Throughout the 28-day Treatment Period
RESEARCH TRIANGLE PARK, NC – June 29, 2010 – Tranzyme Pharma announced positive top-line results today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis, a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested were effective, safe and well tolerated.
TZP-102 resulted in clinically meaningful improvement in the severity of symptoms within one week of treatment initiation. At the end of the once-daily 28-day treatment period, statistically significant improvements in symptom scores for Nausea, Early Satiety, Excessive Fullness, Postprandial Fullness and total GCSI (Gastroparesis Cardinal Symptom Index), were observed, with p-values of 0.029, 0.001, 0.002, 0.020 and 0.015, respectively. The average severity of symptoms during the 28-day treatment (mean of Days 8, 15 & 28) demonstrated similar statistically significant improvements. TZP-102 also improved Upper & Lower Abdominal Pain/Discomfort (p=0.025 and p=0.016). At the end of treatment, over 50% of patients on TZP-102 had normalized gastric emptying (vs. 20% on placebo).
“These positive TZP-102 data are exciting for those of us treating patients with this critical disorder. Patients would truly benefit from a safe and effective oral pharmacologic therapy for gastroparesis,” commented Dr. Richard McCallum, Professor, Founding Chairman, Department of Internal Medicine, Texas Tech University Health Sciences Center at El Paso, and a TZP-102 study investigator. “This represents a medical area with significant unmet need and no recent evidence of any pharmacological advances. I certainly look forward to further exploring the potential of TZP-102 in this and other gastrointestinal motility disorders.”
Dr. Gordana Kosutic, Vice President, Clinical and Regulatory Affairs for Tranzyme said, “We are very pleased with these remarkable results and are now preparing to initiate a 12-week efficacy and safety study in patients with gastroparesis.”
Ninety-two (92) patients with Type 1 or Type 2 diabetes mellitus and a confirmed diagnosis of gastroparesis, documented by the presence of both chronic symptoms and delayed gastric emptying (GE), were enrolled in a Phase 2, double-blind, placebo-controlled parallel group study in the US and EU designed to evaluate the safety and efficacy of TZP-102. Patients were randomly assigned to receive one of three daily doses of TZP-102 (10, 20 & 40 mg administered as a single oral dose) or placebo, for a treatment period of 28 days.
TZP-102’s effects on symptom severity were evaluated by a validated patient-reported outcome (PRO) instrument, the Patient Assessment of Gastrointestinal Symptoms scale (PAGI-SYM), and the Gastroparesis Cardinal Symptom Index (GCSI) after 8, 15, and 28 days of treatment. The effects on GE were assessed by 13C-octanoic acid breath tests.
TZP-102 is an oral ghrelin agonist with potent prokinetic properties currently in clinical development for the treatment of chronic gastrointestinal dysmotility disorders such as gastroparesis, functional dyspepsia, and refractory GERD. The safety and pharmacokinetic profiles of TZP-102 have been extensively characterized in healthy subjects and patients across multiple dose levels, and the effectiveness of the compound is well-established. TZP-102 was discovered by Tranzyme using its proprietary macrocyclic chemistry technology, MATCH™, and targets the ghrelin receptor, which is found throughout the gastrointestinal (GI) tract. Currently, TZP-102 is the most advanced oral medication in development for gastroparesis and other motility disorders affecting the GI tract. In recognition of the critical unmet need, the FDA granted TZP-102 a Fast Track designation for the treatment of gastroparesis in diabetic patients.
Gastroparesis (paralysis of the stomach) is a serious, debilitating condition that affects approximately 4% of the general population and up to 12% of patients with diabetes. It is a progressive disorder characterized by persistent nausea, vomiting, dehydration and difficulty digesting. Gastroparesis results in complications with diabetic medicine, making it difficult for patients to control nutritional and blood glucose levels. Currently, there are no safe and effective treatments for gastroparesis. Earlier prescription medications for this indication were withdrawn from the market or must carry a “black box” warning due to serious side effects.
About Tranzyme Pharma
Tranzyme Pharma is a clinical-stage drug development company that discovers and develops novel small molecule macrocyclic drugs for both acute care (hospital-based) and chronic indications with significant unmet medical needs. The Company’s pipeline is derived from its proprietary drug discovery (chemistry) technology, MATCH™, and targets products for gastrointestinal motility, metabolic diseases and cancer supportive care.
Tranzyme has two corporate partnerships — a broad drug discovery partnership with Bristol-Myers Squibb to discover, develop and commercialize novel drug candidates in multiple therapeutic areas, and a recently announced European licensing agreement with Norgine for the co-development of Tranzyme’s intravenous ghrelin agonist, ulimorelin. www.tranzyme.com.