Tavanta Therapeutics, a pharmaceutical company announced the completion of patient enrollment in the company's l Phase 3 study for TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"). TAVT45CO2 is a global Phase 3 clinical trial evaluating TAVT-45 in patients with metastatic castrate-sensitive prostate cancer (mCSPC) and metastatic castrate-resistant prostate cancer (mCRPC). The primary objective of the study is to establish therapeutic equivalence between TAVT-45 and Zytiga® tablets.
TAVT-45 is designed to provide an easy-to-consume oral suspension of abiraterone acetate, reconstituted in water or juice, for patients with difficulty taking large tablets. Approximately 20 to 30 percent of cancer patients have difficulty swallowing pills and capsules (dysphagia) and may benefit from an alternate formulation. The prevalence of dysphagia also increases with age and is an issue for many patients with prostate cancer, whom have a median age of over 65 years old at time of diagnosis.
This Phase 3 registrational trial (NCT04887506) is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic effect and safety profile of TAVT-45 Granules compared to Zytiga® tablets, in combination with prednisone, in patients with mCSPC and mCRPC. In addition to establishing therapeutic equivalence between TAVT-45 Granules and Zytiga® tablets, the study aims to characterize the multiple-dose pharmacokinetic profile of TAVT-45 Granules. Topline results for the trial are expected by the end of this year.