~ Global Phase 3 Trial Will Establish Therapeutic Equivalence Between TAVT-45 Granules for Oral Suspension and Zytiga® Tablets in Patients with Metastatic Castrate Sensitive Prostate Cancer (mCSPC) and Metastatic Castrate Resistant Prostate Cancer (mCRPC) ~
~ Potential to Become First FDA-Approved Granules for Oral Suspension Formulation of Abiraterone Acetate Which Reduces Pill Burden for Patients and is Administered at a Lower Dose Due to Increased Bioavailability ~
Radnor, Pa., May 25, 2021 – Tavanta Therapeutics, a specialty pharmaceutical company, today announced 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). 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.
“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,[i] 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,[ii] 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.[iii],[iv] 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.
About Tavanta Therapeutics and Technology Platforms
Tavanta Therapeutics (Tavanta), headquartered in the greater Philadelphia area, is a clinical stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs designed to bring clinically meaningful benefits to patients with unmet medical needs. 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. The result is a business model designed to lower the risk associated with the early stages of drug development, aimed toward accelerating new drug candidates into the clinic to reach patients with unmet medical needs.
Conditions represented in the Tavanta pipeline include metastatic castration-resistant prostate cancer and high-risk metastatic castration-sensitive prostate cancer (Phase 3), anal fissures (Phase 2), tuberous sclerosis complex (investigator sponsored Phase 1/2), and cystic fibrosis (Discovery/preclinical). Tavanta makes use of strategic partnerships early in the drug candidate identification process through in-licensing of drug targets to complement its own internally developed pipeline. The Company also seeks collaborative relationships for the development and commercialization of certain clinical candidates and welcomes inquiries from interested parties.
Tavanta has established two platforms to support the rapid screening, identification, and design of drug products for clinical development: High Throughput (HT) Matrix Screening Platform, and the Peptide Conjugate Development (PCD) Platform. The proprietary HT Matrix Screening platform is a bottom-up approach to improving the pharmacokinetic properties of poorly soluble pharmaceuticals, leading to the enhancement of certain critical product characteristics. The PCD Platform is an integration of synthesis, in-vitro and pre-clinical in-vivo testing designed to synthesize, screen, characterize and design new peptides and peptide conjugates.
Zytiga® is a registered trademark of Janssen Biotech, Inc.
Lynne Powell, CEO,
Elixir Health Public Relations
[i] National Cancer Institute. SEER Cancer Stat Facts: Prostate Cancer. Accessed at https://seer.cancer.gov/statfacts/html/prost.html on May 4, 2021.
[ii] National Cancer Institute. SEER Cancer Stat Facts: Prostate Cancer. Accessed at https://seer.cancer.gov/statfacts/html/prost.html on May 4, 2021.
[iii]Carton 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.
[iv]van 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.