Pharmaceutical Pipeline FY Q2 Highlights:
VERU-111 for Advanced Prostate Cancer
“Our drug product development continues to progress at a substantial pace,” said Dr. Steiner. “Last week we announced exciting results from our Phase 1b clinical trial ofVERU-111 for the treatment of metastatic castration resistant prostate cancer (mCRPC) in men who have also become resistant to novel androgen blocking agents such as abiraterone or enzalutamide. As for safety, the maximum tolerated dose (MTD) ofVERU-111 was determined to be 72mg (3 of 11 men had reversible Grade 3 diarrhea). No Grade 3 diarrhea was observed at doses less than 72 mg per day. At doses ofVERU-111 of 63 mg and lower per day, mild to moderate nausea, vomiting, diarrhea and fatigue were the most common adverse events. There were no reports of neurotoxicity and no neutropenia at doses 63 mg and lower oral daily dosing continuous for 21 days per cycle.”
“Efficacy (antitumor activity) was assessed by serum PSA and standard local imaging with bone and CT scans. In the eight men that received at least four21-day cycles of oralVERU-111 at any dose, based upon their21-day cycle baseline PSA levels, 6/8 (75%) had decreases in their PSA levels, 4 patients (50%) demonstrated a³ 30% decline, and 2 patients (25%) had a³ 50% decline in serum PSA. Based upon PCWG3 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, objective tumor responses were seen in 2 patients (25%) (soft tissue and bone) and 5/8 patients (63%) had stable disease. Objective tumor responses and PSA declines lasted longer than 12 weeks. The primary endpoint used in pivotal efficacy studies for the treatment of metastatic castration-resistant prostate cancer is median time to cancer progression by imaging (bone and CT scans). In the current study, median duration of response, or time to cancer progression, has not been reached since 7 out of 8 of the men are still being treated on the study with an average duration of response of 10 months (range =6-14 months). There are an additional 3 subjects on study that have not yet completed four21-day cycles; therefore, a total of 10 men are still on study. Based on the positive data from the Phase 1b study, we have initiated and are continuing to enroll patients in the Phase 2 portion of the study. We will meet with FDA next quarter to gain agreement on the registration Phase 3 design for this indication. We also plan to present an update of the Phase 1b/2 clinical data at the next possible upcoming major scientific meeting. We believeVERU-111, with a different mechanism of drug action, could address this significant unmet medical need as a treatment for this rapidly growing indication, metastatic castration and androgen blocking agent resistant prostate cancer prior to IV chemotherapy.”
VERU-111 Possible Treatment forCOVID-19
“Yesterday we received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy ofVERU-111 in combatingCOVID-19, the global pandemic disease caused by the novel coronavirusSARS-CoV-2. We have initiated the study and expect the first patient to be dosed within 2 weeks. We believe thatVERU-111, a microtubule depolymerization agent that has broad antiviral activity, could be effective against the SARSCoV-2 virus by disrupting its intracellular transport along the microtubules. Microtubule trafficking is critical for viruses to cause infection. Furthermore, microtubule depolymerization agents that target α and ß tubulin subunits of microtubules, likeVERU-111, also have strong anti-inflammatory effects, including the potential to treat the cytokine release syndrome (cytokine storm) and septic shock induced by theSARS-CoV-2 viral infection that seems to be associated with highCOVID-19 mortality rates.”
“Based on the strong pharmacologic rationale, as well as the preclinical and clinical studies supporting both the antiviral and anti-inflammatory effects ofVERU-111 and its acceptable safety profile to date, we will proceed with this placebo-controlled Phase 2 study in patients that have been hospitalized forSARS-CoV-2 and who are at high risk for Acute Respiratory Distress Syndrome (ARDS) . The small study is designed to evaluateVERU-111’s ability to improve pulmonary symptoms and recovery and to avoid the need for mechanical ventilation.”
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