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.
In the trial, 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 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.
Tranzyme Pharma said that 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. At the end of treatment, over 50% of patients on TZP-102 had normalized gastric emptying (vs 20% on placebo).
Richard McCallum, a TZP-102 study investigator, said: “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.
“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.”
Gordana Kosutic, vice president of 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.”