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.
“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”
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.
"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."