Veru Announces ESMO Congress 2020 Acceptance of VERU-111, a Novel Oral Tubulin Targeting Agent, Phase 1b/2 Study in Metastatic Prostate Cancer as an Oral Presentation

MIAMI, July 27, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that the clinical results from its Phase 1b/2 study of VERU-111 have been accepted for oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 to be held September 19-21, 2020. VERU-111 is a novel, oral, first-in-class, tubulin targeting agent that crosslinks and disrupts alpha and beta tubulin subunits of microtubules. VERU-111 is in clinical development to treat metastatic castration and novel androgen receptor targeting agent (enzalutamide or abiraterone) resistant prostate cancer, a growing unmet medical need in advanced prostate cancer.

Presentation details:

1. Abstract Title: Phase 1b/2 study of VERU-111, novel, oral tubulin inhibitor, in men with metastatic castration resistant prostate cancer who failed an androgen blocking agent 
   Presenter:  Mark Markowski, MD, PhD, Assistant Professor of Oncology, The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center 
   Abstract Number: 2863

Additional information on the meeting can be found on the ESMO website https://www.esmo.org/meetings/esmo-virtual-congress-2020.

“We are looking forward to sharing the clinical results evaluating VERU-111 in a Phase 1b/2 trial in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer,” said Mitchell Steiner, MD, Chairman, President and CEO of Veru Inc.  “The presentation will focus on the clinical data from the Phase 1b clinical study. The ongoing Phase 2 clinical study portion has almost completed enrollment.”

About Veru Inc.
Veru Inc. is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta tubulin subunits of microtubules. VERU-111 is being evaluated in an open label Phase 1b/Phase 2 clinical study in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer. The Phase 1b clinical study completed enrollment of 39 men and is ongoing. The Phase 2 clinical study is enrolling approximately 40 men who have metastatic castration resistant prostate cancer and who have also become resistant to at least one novel androgen receptor targeting agents, such as abiraterone or enzalutamide, but prior to proceeding to IV chemotherapy. VERU-111 is also being evaluated in a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19. VERU-100 is a novel, proprietary peptide formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist administered as a small volume, subcutaneous 3-month depot injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration --- a problem which occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection. A Phase 2 study to evaluate VERU-100 dosing is anticipated to begin in the fourth quarter of calendar year 2020.  Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. Following an End of Phase 2 meeting with the FDA, the Company plans to advance Zuclomiphene Citrate to a Phase 3 clinical trial in men with advanced prostate cancer who experience moderate to severe hot flashes.