~ Novel Oral Suspension Formulation of Abiraterone Acetate Designed to Address Needs of Metastatic Prostate Cancer Patients Who Have Difficulty Swallowing (Dysphagia), an Issue for 20 to 30 Percent of Prostate Cancer Patients ~
~ Topline Results Expected in Q4 2022; Company Plans to Submit a New Drug Application (NDA) to the U.S. Food & Drug Administration in Q3 2023 ~
KING OF PRUSSIA, Pa., Aug. 1, 2022 /PRNewswire/ — 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.”
TAVT-45 Granules is an enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 Granules may provide an alternative for the 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets and may increase the bioavailability of abiraterone and therefore allow a lower dose to be administered. In addition to the multiple large tablets required daily, other limitations of Zytiga® include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure has been shown to result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.i,ii It is anticipated that TAVT-45 Granules may be given regardless of food consumption and may result in fewer patients having sub-optimal abiraterone trough plasma concentrations.
Tavanta Therapeutics (Tavanta), headquartered in King of Prussia Pa., is a clinical stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs designed to bring clinically meaningful benefits to patients with serious or debilitating diseases. Tavanta has developed a risk-balanced approach to discovery and product development by both enhancing the clinical performance of established molecules and synthesizing novel small molecules and therapeutic peptides.
Conditions represented in the Tavanta pipeline include metastatic prostate cancer (Phase 3), anal fissures (Phase 3), and cystic fibrosis (preclinical).
Zytiga® is a registered trademark of Janssen Biotech, Inc.
Lynne Powell, CEO,
Elixir Health Public Relations
iCarton E, Noe G, Huillard O, et al. Relation between plasma trough concentration of abiraterone and prostate-specific antigen response in metastatic castration-resistant prostate cancer patients. Eur J Cancer. 2017;72:54-61.
iivan Nuland M, Groenland SL, Bergman AM, et al. Exposure-response analyses of abiraterone and its metabolites in real-world patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020;23(2):244-251.