Veru Announces Positive Updated Data from Phase 1b/2 Sabizabulin Study in Men With Metastatic Castration-Resistant Prostate Cancer

Veru Inc. recently announced that updated clinical data from the positive Phase 1b/2 study of sabizabulin (VERU-111) in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel androgen receptor targeting agent were presented at the European Society for Medical Oncology (ESMO) Congress (September 16-21, 2021). Sabizabulin is a new oral chemical entity that represents a novel class of agents that target unique binding sites on microtubules to disrupt both the cytoskeleton and androgen receptor transport.

Highlights of the presentation:

The oral presentation provided an updated analysis of mature data that combines approximately 80 patients enrolled in both the Phase 1b and 2 portions of the study. Heavily pretreated patients were enrolled who had tumor progression on androgen deprivation therapy and a novel androgen receptor targeting agent (approximately 40% had tumor progression after at least 2 androgen receptor targeting agents).

As for safety, there were 54 men treated at the recommended Phase 2 dose of sabizabulin 63 mg oral daily dosing in the Phase 1b/2 combined study. Sabizabulin was well tolerated with no clinically relevant neutropenia or neurotoxicity. The most common adverse events observed were gastrointestinal related (diarrhea, nausea, and fatigue), which were predominantly Grades 1 and 2.

As for efficacy, combining patients in Phase 1b/2 study who received 63-mg sabizabulin daily with measurable metastatic disease at baseline (PCWG3 criteria), the median rPFS is estimated to be approximately 7.4 months (3.2 – 30.0+ months) as 5 patients remain on study of which two of which have been on sabizabulin without tumor progression for more than 2 years. In the Phase 1b/2 population with measurable disease at baseline per RECIST 1.1, the Overall Response Rate (ORR) was 21%.

“The updated data from this clinical trial continue to demonstrate that daily oral sabizabulin administration is feasible and well tolerated,” said Dr. Mark Markowski, an Assistant Professor of Oncology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and the presenter of these results. “Further, long-term responses in this heavily pretreated patient population are demonstrative of the promising efficacy which is currently being tested in the Phase 3 VERACITY study.”

“These updated findings from our clinical study of sabizabulin continue to support the potential role of sabizabulin in filling a growing unmet medical need in the treatment of men with metastatic prostate cancer that have tumor progression with androgen deprivation and novel androgen receptor targeting agent therapy, but prior to IV chemotherapy. Based on this Phase 1b/2 study, sabizabulin has a safety profile similar to what has been reported in the literature for novel androgen receptor targeting agents and with promising efficacy. We are greatly anticipating the results of our ongoing Phase 3 VERACITY study which is enrolling in 45 clinical centers in the US,” said Dr. Mitchell S. Steiner, Chairman, President and CEO of Veru Inc.

Sabizabulin is a novel oral new chemical entity that targets unique binding sites in microtubules to disrupt both the cytoskeleton and androgen receptor transport. In June 2021, the company initiated the open label, randomized (2:1), multicenter Phase 3 VERACITY clinical trial evaluating sabizabulin 32 mg versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have failed at least one androgen receptor targeting agent. The 32-mg dose formulation being studied in the VERACITY study has similar bioavailability to the 63-mg dose formulation used in the Phase 1b/2 study. The primary endpoint is median radiographic progression free survival. The Phase 3 VERACITY clinical trial is anticipated to enroll approximately 245 patients from 45 clinical centers.

Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer. Veru’s prostate cancer pipeline includes: sabizabulin, an oral, first-in-class, new chemical entity that targets the cytoskeleton which in prostate cancer also disrupts the transport of the androgen receptor. A Phase 3 VERACITY clinical trial evaluating the efficacy and safety of sabizabulin in approximately 245 men for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer is enrolling. VERU-100, a novel, proprietary gonadotropin releasing hormone antagonist peptide long acting 3-month subcutaneous injection formulation for androgen deprivation therapy to treat hormone sensitive advanced prostate cancer, is currently enrolling in a Phase 2 clinical trial, and the Phase 3 clinical trial is planned to initiate in calendar Q4 2021. Veru’s breast cancer pipeline includes: enobosarm, an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets the androgen receptor, a tumor suppressor, to treat AR+ER+HER2- metastatic breast cancer without unwanted masculinizing side effects. The enobosarm clinical program is initially focusing on 2 indications: 1) Phase 3 ARTEST clinical trial to evaluate enobosarm monotherapy in a 3rd line metastatic setting in approximately 210 subjects with AR+ER+HER2- metastatic breast cancer (≥ 40% AR positivity) who have failed nonsteroidal aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor which is anticipated to commence soon; and 2) Phase 2b study to evaluate the efficacy and safety of enobosarm and CDK 4/6 inhibitor, abemaciclib, combination compared to estrogen blocking agent (Active Control) for the treatment of AR+ER+HER2- metastatic breast cancer in a 2nd line metastatic setting in approximately 186 patients who have failed first line treatment in a metastatic setting with CDK 4/6 inhibitor, palbociclib, in combination with either an aromatase inhibitor or fulvestrant which is expected to commence in calendar Q4 2021. Sabizabulin will also be evaluated in a three arm Phase 2b clinical study planned to initiate in calendar Q3 2021 to evaluate oral daily dosing of sabizabulin monotherapy and sabizabulin + Trodelvy (sacituzumab govitecan-hziy) combination therapy versus Trodelvy monotherapy in approximately 216 women with metastatic triple negative breast cancer that have become resistant to at least two systemic chemotherapies. Based on positive Phase 2 results on the reduction of mortality, sabizabulin is also being evaluated in a Phase 3 clinical trial for the treatment of hospitalized patients with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome in approximately 300 subjects and is currently enrolling in the US and South America.

The company’s Sexual Health Business commercial product is the FC2 Female Condom (internal condom) (FC2), an FDA-approved product for dual protection against unintended pregnancy and the transmission of sexually transmitted infections. The company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the US and globally. In the US, FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, UN agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. The second potential commercial product, if approved, expected for the Sexual Health Business is TADFIN™ (tadalafil 5mg and finasteride 5mg capsule) dosed daily for benign prostatic hyperplasia (BPH). PDUFA date for the NDA is in December 2021. The Company plans to initially launch through telemedicine and telepharmacy sales channels. For more information, visit www.verupharma.com.