Veru Announces ESMO Congress 2020 Oral Presentation of Positive Clinical Results from its VERU-111 Phase 1b Study in Metastatic Prostate Cancer

—Advancing VERU-111 to a Pivotal Phase 3 Clinical Program—

MIAMI, Sept. 18, 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 positive clinical results from its Phase 1b study of VERU-111 were orally presented at the European Society for Medical Oncology (ESMO) Congress 2020.

The results of the Phase 1b study evaluating VERU-111, a novel oral microtubule targeting agent that selectively inhibits alpha and beta tubulin, in 39 men with metastatic castration resistant prostate cancer that have also failed at least one androgen receptor targeting agent (enzalutamide or abiraterone) and a large and growing unmet medical need in advanced prostate cancer, have been presented as an oral presentation by Mark Markowski, MD, Assistant Professor of Oncology from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. The oral presentation is entitled “Phase 1b/2 study of VERU-111, novel, oral tubulin inhibitor, in men with metastatic castration resistant prostate cancer (mCRPC) who failed an androgen blocking agent.″

The highlights of the study were as follows:

• Phase 1b portion of the study enrolled 39 men in 7 clinical sites in the United States and used a two-part dosing schedule with a standard 3+3 dose escalation strategy followed by an expanded dose and dose schedule of VERU-111 daily continuous dosing until disease progression or toxicity.
• Patient demographics: 44% failed both abiraterone and enzalutamide; 55% had bone only metastatic disease.
• The Maximum Tolerated Dose (MTD) of VERU-111 was 72mg (3 /11 men had Grade 3 diarrhea).  No Grade 3 diarrhea was observed at doses