Tavanta Therapeutics Announces Positive Top-line Results from Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer

• Trial Met Primary Endpoint Demonstrating Therapeutic Equivalence Between TAVT-45 and Zytiga^® and Showed a Comparable Safety Profile
• Results Suggest TAVT-45 Has the Potential to Become an Easy-to-Swallow Alternative to Zytiga^®, Benefitting Many Patients with Dysphagia or Difficulty Swallowing

KING OF PRUSSIA, Pa., Jan. 5, 2023 /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 positive top-line results from its pivotal, global Phase 3 clinical trial, evaluating the safety and efficacy of TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), an investigational enhanced formulation of abiraterone acetate for the treatment of metastatic prostate cancer. The trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga^® in patients with metastatic castrate-resistant prostate cancer (mCRPC) and metastatic high-risk castrate-sensitive prostate cancer (mCSPC), in addition to demonstrating a comparable safety profile.

The primary endpoint comparing serum testosterone levels at Days 9 and 10 was met, demonstrating therapeutic equivalence between TAVT-45 and Zytiga^®. The key secondary endpoint (a decrease of ≥ 50% in prostate-specific antigen [PSA] levels from baseline at any time over the 84-day treatment period) showed no statistical difference between treatment arms. The safety profile of TAVT-45 in the trial was in line with that of Zytiga^®.

"The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga^®, benefitting many patients with dysphagia or difficulty swallowing large tablets," said Andreas Maetzel, M.D. Ph.D., chief medical officer of Tavanta Therapeutics. "Approximately 20 to 30 percent of cancer patients, including many patients with prostate cancer, have difficulty swallowing pills and capsules.^i,ii We believe these patients may benefit from an alternate formulation like TAVT-45 that would allow them to take their much-needed medications in an easier-to-take formulation."

The Phase 3 registrational trial (Study TAVT45C02; NCT04887506) is a global, randomized, multi-center, open-label trial designed to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga^® tablets, in combination with prednisone, in patients with mCRPC and high-risk mCSPC. In addition to establishing therapeutic equivalence between TAVT-45 and Zytiga^® tablets, the study aims to characterize the multiple-dose pharmacokinetic profile of TAVT-45.

"It is encouraging to see a familiar efficacy and safety profile for TAVT-45, which is consistent with data established for abiraterone acetate as a standard of care in the treatment of metastatic prostate cancer," said Kenneth M. Kernen, M.D., study investigator and partner in the Michigan Institute of Urology. "The positive results from this clinical study further support and validate the use of TAVT-45 as a novel, oral, easy-to-drink formulation of abiraterone acetate. As a physician, this would be a welcome potential treatment alternative that may also help patients adhere to their medication regimens and may ultimately improve clinical outcomes."

"We would like to thank the clinical study site investigators and the patients who participated in this pivotal trial," said Lynne Powell, chief executive officer of Tavanta Therapeutics. "Tavanta intends to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), while also evaluating strategic options for the commercialization of TAVT-45."

Tavanta intends to present detailed results from this Phase 3 registrational study, TAVT45C02, at an upcoming medical meeting, as well as submit for publication.

TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), 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 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.^iii,iv It is anticipated that TAVT-45 may be taken 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, anal fissures, and cystic fibrosis.

For more information, visit https://www.tavanta.com/ and connect with us on LinkedIn. Zytiga^® is a registered trademark of Janssen Biotech, Inc.

Contacts:

Corporate:
Lynne Powell, CEO
[email protected]

Media:
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
[email protected]

ⁱ Frowen J, Hughes R, Skeat J. The prevalence of patient-reported dysphagia and oral complications in cancer patients. Support Care Cancer. 2020 Mar;28(3):1141-1150.
ⁱⁱ Drumond N, Stegemann S. Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience. Pharmaceutics. 2020 Dec 28;13(1):32.
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.

SOURCE Tavanta Therapeutics