Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases, today announced the completion of patient enrollment in the Company's pivotal 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.
"The current standard of care treatment for metastatic prostate cancer requires patients to ingest multiple large tablets, and under strict fasting conditions due to the risk of increased and highly variable abiraterone exposures with food," said Kenneth M. Kernen, M.D., study investigator and partner in the Michigan Institute of Urology. "Dysphagia is an issue for many – and it occurs more frequently in elderly patients. If TAVT-45 proves successful in this trial, clinicians may soon have access to an alternative, easy-to-drink formulation of abiraterone acetate with improved bioavailability and reduced systemic variability, which may ultimately help patients achieve better clinical outcomes."
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.
"On behalf of Tavanta, we would like to thank the clinical study site investigators and the patients who are participating in and supporting this pivotal trial, especially in light of the ongoing challenges of the COVID-19 pandemic. We look forward to completing the dosing and follow-up phases of the study," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "As we work to complete this registrational trial for TAVT-45, we will begin preparing for the submission of our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023, while also evaluating strategic options for commercialization of TAVT-45."
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