Tavanta Therapeutics has concluded subject enrolment in its pivotal Phase III clinical trial of TAVT-45 (abiraterone acetate) granules for oral suspension in metastatic castrate-sensitive prostate cancer (mCSPC) and metastatic castrate-resistant prostate cancer (mCRPC) patients.
Named TAVT45CO2, the international, randomised, multicentre, open-label trial will analyse the pharmacodynamic effect and safety profile of TAVT-45 granules versus Zytiga tablets, along with prednisone, in these patients.
Establishing therapeutic equivalence between TAVT-45 and Zytiga tablets is the trial’s primary objective.
The registrational trial also intends to characterise the therapy’s multiple-dose pharmacokinetic profile.
The company anticipates topline data from the trial in the fourth quarter of this year.
An improvised formulation of abiraterone acetate, TAVT-45 granules are intended to treat metastatic prostate cancer.
In cancer patients having dysphagia or trouble swallowing pills and capsules, the granules offer an easy-to-consume oral suspension of abiraterone acetate, which can be reconstituted in water or juice.
The bioavailability of abiraterone could be raised when TAVT-45 granules are mixed with water or juice to create an oral suspension and could permit the administration of a reduced treatment dose.
Tavanta Therapeutics CEO Lynne Powell said: “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.
“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 US Food and Drug Administration (FDA ) in the third quarter of 2023, while also evaluating strategic options for commercialisation of TAVT-45.”