Veru Completes Enrollment of Phase 2 Clinical Trial of Novel Oral Drug


Veru Inc. recently announced it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for metastatic castration and novel androgen receptor targeting agent resistant prostate cancer. The study enrolled a total of 40 men at 13 clinical sites in the US.

The open label, single arm, Phase 2 clinical trial will evaluate the efficacy and safety of VERU-111 in 40 men with metastatic prostate cancer who have become resistant to at least one androgen receptor targeting agent (abiraterone or enzalutamide), but prior to IV chemotherapy in the metastatic setting. Enrolled men will receive 63 mg of VERU-111 per day, the recommended dose selected from the Phase 1b portion of the study which was conducted in 39 men. In the Phase 1b study, VERU-111 63mg oral daily continuous dosing chronic administration was well tolerated with no reports of neurotoxicity, hypersensitivity (allergic) reactions and neutropenia. Promising antitumor activity was also observed in the Phase 1b clinical study with evidence of PSA declines, objective tumor responses, and durable responses. The key efficacy endpoint of the Phase 2 study is radiographic imaging of progression-free survival.

“We are excited to have fully enrolled the phase 2 portion of the Phase 1b/2 clinical trial evaluating the recommended 63 mg oral daily continuous dosing of VERU-111 for metastatic castration and androgen receptor targeting agent resistant prostate cancer,” said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru. “Based on positive clinical results from the Phase 1b portion, which were presented at ESMO on September 18, 2020, as well as the current study results observed thus far from the open label Phase 2 study, we met with FDA in July 2020. With the positive FDA input, we plan to submit the final Phase 3 pivotal registration study to FDA in Q4 2020 and meet with EMA in Q1 2021.”

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/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 has completed the enrollment of 40 men who have metastatic castration resistant prostate cancer and who have also become resistant to at least one novel androgen receptor targeting agent, such as abiraterone or enzalutamide, but prior 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. An IND is expected to be submitted for the Phase 2 study to evaluate VERU-100 dosing in the fourth quarter of calendar year 2020 and a Phase 2 clinical trial is anticipated to commence Q1 2021. 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.

Veru is also advancing new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology such as the Tadalafil and Finasteride Combination (TADFIN) for the administration of tadalafil 5 mg and finasteride 5mg combination formulation dosed daily for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5 mg PROSCAR) and male pattern hair loss (finasteride 1 mg PROPECIA). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone. The Company had a successful pre-NDA meeting with the FDA and the expected submission of the NDA for TADFIN is the fourth quarter of calendar year 2020 or early 2021. Veru is also developing Tamsulosin XR capsules which is a formulation of tamsulosin, the active ingredient in FLOMAX, which Veru has designed to avoid the “food effect” inherent in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance.

The company’s commercial products include the FC2 Female Condom/FC2 Internal Condom (FC2), an FDA-approved product for the dual protection against unwanted pregnancy and the transmission of sexually transmitted infections, and the PREBOOST 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. 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. PREBOOST is marketed through online sales in the US under the Roman Swipes brand name by Roman, the digital men’s health clinic. Roman offers online treatment for a variety of men’s health conditions. For more information, visit www.verupharma.com.