On May 25, 2021 Tavanta Therapeutics, a specialty pharmaceutical company, reported that the first patient has been dosed in a recently initiated global Phase 3 clinical trial evaluating TAVT-45 (abiraterone acetate) Granules for oral suspension (TAVT-45 granules), a novel and proprietary formulation of abiraterone acetate. In agreement with the U.S. Food and Drug Administration (FDA), the safety and efficacy of TAVT-45 Granules is being studied in a single Phase 3 trial as a treatment for metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC) (Press release, Tavanta Therapeutics, MAY 25, 2021, View Source [SID1234580581]). TAVT-45 Granules was designed as an alternative for patients who have difficulty swallowing (dysphagia), which can be a side effect of some cancer treatments and occurs more frequently in elderly patients. TAVT-45 was also developed to address some of the limitations of current abiraterone treatment, including low bioavailability, high variability in systemic exposure, and large food effect.
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"We are excited to be the first clinical trial site to dose a patient in this trial" said Dr. Robert Given, a urological oncologist at Urology of Virginia and a study investigator. "The current standard of care treatment 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. In contrast, TAVT-45 Granules has the potential to provide the more than 3.2 million prostate cancer patients in the United States,1 specifically those with dysphagia, with an alternative option that would reduce pill burden."
This single 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. The primary objective of the trial is to establish therapeutic equivalence between TAVT-45 Granules and Zytiga tablets. The secondary objective is to characterize the multiple-dose pharmacokinetic profile of TAVT-45 Granules in a cohort of patients. Tavanta has met and aligned with the FDA regarding the design of the single trial required for registration. The trial, which aims to recruit a total of 108 patients, is expected to complete enrollment within the second quarter of 2022.
"As one of the most frequently diagnosed cancers in men in the United States,2 prostate cancer affects a large population of men with unmet medical needs, like dysphagia, and not all can be met with current treatment options," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "Dosing the first patient in this pivotal TAVT-45 study reinforces Tavanta’s commitment to provide an alternative formulation of abiraterone acetate for prostate cancer patients. Importantly, this novel formulation may support improved bioavailability and reduced systemic variability using a lower dose of drug compared to the standard of care, which may ultimately help patients achieve better clinical outcomes."
Powell added, "Tavanta is advancing a diverse pipeline of specialty drugs designed to bring clinically meaningful benefits to patients with unmet medical needs. We are excited that TAVT-45, our most advanced product candidate, has reached this important clinical development milestone."
About TAVT-45 Granules
TAVT-45 Granules is an enhanced formulation of abiraterone acetate for the treatment for prostate cancer. TAVT-45 Granules was designed to be an improved formulation of the commercially available Zytiga (abiraterone acetate) tablets and developed using the High Throughput (HT) Matrix Screening Platform at Tavanta. When reconstituted with water or juice to yield an oral suspension, TAVT-45 Granules may increase the bioavailability of abiraterone and therefore allow a lower dose to be administered while also providing an alternative to patients who suffer from dysphagia or have difficulty swallowing tablets. 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.3,4 It is anticipated that TAVT-45 treatment may be given regardless of food consumption and may result in less patients having sub-optimal abiraterone trough plasma concentrations.