Veru Inc. announced the presentation of the Phase 1b/2 clinical trial update of sabizabulin (VERU-111), an oral cytoskeleton disruptor which in prostate cancer also disrupts androgen receptor transport, to treat men with metastatic castration resistant prostate cancer who failed at least one androgen receptor targeting agent, at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting being held June 4-8, 2021. The Phase 1b/2 clinical study was designed as a dynamic study with an initial 3+3 standard safety study component followed by an expanded study with increases in dose and schedule. The Phase 1b/2 clinical trial enrolled 80 men and is ongoing with patients in both the Phase 1b and 2 components still on study. Highlights of the study presentation are as follows: Sabizabulin oral daily dosing was well tolerated, and the most common adverse events, being mostly Grade 1 and 2, were diarrhea, fatigue, nausea, and decrease in appetite. There was no evidence of clinically relevant neutropenia or neurotoxicity. Safety profile was similar to that reported in package inserts for androgen receptor targeting agents, abiraterone and enzalutamide. Clinically meaningful and durable evidence of objective tumor responses were observed in patients on 63mg oral daily dosing schedule: In the ITT population with measurable disease (n=29), the ORR (5 partial responses + 1 complete response) was 20.7%. the Phase 1b study, ITT population of men that received at least 1 dose of 63mg daily dosing schedule (n=14), the median progression free survival was 10.8 months (2.3-26+ months). Two of these patients on continuous daily dosing of sabizabulin have now reached 27 months and 23 months of treatment without prostate cancer progression. In the Phase 1b/2 study of men that received at least 1 dose of 63mg daily dosing schedule (n=55), the study is still ongoing, the median progression free survival has not been reached as 10 men were still on study at the time of data cut off. The estimated radiographic progression free survival is greater than 7.4 months. Sabizabulin is a novel, oral, new chemical entity that targets microtubules in the cytoskeleton to disrupt androgen receptor transport into the nucleus. Sabizabulin is in clinical development for: (1) Phase 3 VERACITY study for the treatment of men with metastatic castration resistant prostate cancer who have failed at least one androgen receptor targeting agent but prior to receiving chemotherapy. The open-label, randomized (2:1), multicenter Phase 3 study is expected to begin enrollment this month to evaluate sabizabulin 32mg versus the alternative androgen receptor targeting agent. Based on the recently conducted PK study from the Phase 2 clinical trial, the blood levels of the Phase 3 clinical trial sabizabulin 32mg drug dose formulation were similar to the Phase 1b/2 63mg dosage formulation. The Phase 3 VERACITY clinical trial is expected to enroll approximately 245 patients. (2) Phase 2 clinical study for the treatment of women with metastatic triple negative breast cancer who have become resistant to at least two systemic chemotherapies. The Phase 2b clinical study will evaluate daily oral dosing of sabizabulin monotherapy, TRODELVY® monotherapy, and sabizabulin + TRODELVY® combination therapy in approximately 156 women. The Phase 2b clinical study is expected to commence in the third quarter of calendar 2021. (3) Phase 3 clinical trial for the treatment of hospitalized patients with moderate to severe COVID-19 who are at high risk for ARDS. Sabizabulin 9mg is being evaluated as a monotherapy versus placebo. The Phase 3 clinical study is actively enrolling patients.