–Sabizabulin is a novel oral androgen receptor transport disruptor–
— In Phase 1b/2 clinical study, sabizabulin was well tolerated with significant antitumor efficacy in metastatic castration resistant prostate cancer patients who have also become resistant to abiraterone or enzalutamide, but prior to IV chemotherapy–
–Phase 3 clinical study will be conducted in 45 clinical centers across the United States–
MIAMI, FL, USA I June 25, 2021 I Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that it has enrolled the first patient in its Phase 3 VERACITY clinical trial of sabizabulin, an oral, first-in-class, new chemical entity, androgen receptor transport disruptor (targets and inhibits microtubules to disrupt androgen receptor transport into the nucleus), for metastatic castration and androgen receptor targeting agent resistant prostate cancer.
The Phase 3 VERACITY clinical trial is an open label, randomized (2:1), multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have progressed on at least one androgen receptor targeting agent. The primary endpoint is median radiographic progression free survival and key secondary endpoints are overall response rate, duration of objective response, overall survival, time to chemotherapy, and pain progression. The study is expected to enroll 245 patients and will be conducted in over 45 clinical sites across the United States.
“Unfortunately, advanced prostate cancer patients receiving androgen receptor targeting agents in combination with standard ADT will eventually have tumor progression. There is a significant need for new therapies with novel mechanisms of action. Sabizabulin is a novel, oral agent with provocative levels of activity and safety in early studies and we are now prospectively evaluating this agent in a Phase 3 study,” said Robert Dreicer, M.D., Deputy Director, UVA Cancer Center, Director of Solid Tumor Oncology, Professor, Medicine: Hematology and Oncology and lead principal investigator for the VERACITY study.
“We are excited to begin enrolling patients in our open label Phase 3 VERACITY clinical trial,” said Mitchell Steiner, MD, Chairman, President and CEO of Veru Inc. “As we have previously reported, in the Phase 1b/2 clinical trial sabizabulin had significant evidence of tumor efficacy including PSA declines and responses as well as objective and durable tumor responses. Furthermore, sabizabulin was well tolerated without neutropenia. In fact, the safety profile of sabizabulin appears to be similar to what is reported in the package inserts for an androgen receptor targeting agent such as enzalutamide or abiraterone. If the Phase 3 is successful, sabizabulin could be the next ‘go to drug’ in the largest and growing unmet medical need in men who have metastatic castration resistant prostate cancer and who have developed progression of prostate cancer while being treated with an androgen receptor targeting agent, but prior to using IV chemotherapy.”
About Veru Inc.
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 disruptor 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, is currently enrolling, and the Phase 3 clinical study is planned to initiate in calendar Q4 2021 to treat hormone sensitive advanced prostate cancer. 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 calendar Q3 2021; 2) Phase 2 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 (≥ 40% AR positivity) in a 2nd line metastatic setting in approximately 106 patients who have failed 1st 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 Q3 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, TRODELVY® monotherapy, and sabizabulin + TRODELVY combination therapy in approximately 156 women with metastatic triple negative breast cancer that have become resistant to at least two systemic chemotherapies including a taxane. 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.
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 U.S. and globally. In the U.S., 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, U.N. 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). An NDA was filed by FDA in April 2021 with a PDUFA date in December 2021. The Company plans to launch through telemedicine and telepharmacy sales channels. To learn more about Veru products, please visit www.verupharma.com.
SOURCE: Veru
Post Views: 23
–Sabizabulin is a novel oral androgen receptor transport disruptor–
— In Phase 1b/2 clinical study, sabizabulin was well tolerated with significant antitumor efficacy in metastatic castration resistant prostate cancer patients who have also become resistant to abiraterone or enzalutamide, but prior to IV chemotherapy–
–Phase 3 clinical study will be conducted in 45 clinical centers across the United States–
MIAMI, FL, USA I June 25, 2021 I Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that it has enrolled the first patient in its Phase 3 VERACITY clinical trial of sabizabulin, an oral, first-in-class, new chemical entity, androgen receptor transport disruptor (targets and inhibits microtubules to disrupt androgen receptor transport into the nucleus), for metastatic castration and androgen receptor targeting agent resistant prostate cancer.
The Phase 3 VERACITY clinical trial is an open label, randomized (2:1), multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have progressed on at least one androgen receptor targeting agent. The primary endpoint is median radiographic progression free survival and key secondary endpoints are overall response rate, duration of objective response, overall survival, time to chemotherapy, and pain progression. The study is expected to enroll 245 patients and will be conducted in over 45 clinical sites across the United States.
“Unfortunately, advanced prostate cancer patients receiving androgen receptor targeting agents in combination with standard ADT will eventually have tumor progression. There is a significant need for new therapies with novel mechanisms of action. Sabizabulin is a novel, oral agent with provocative levels of activity and safety in early studies and we are now prospectively evaluating this agent in a Phase 3 study,” said Robert Dreicer, M.D., Deputy Director, UVA Cancer Center, Director of Solid Tumor Oncology, Professor, Medicine: Hematology and Oncology and lead principal investigator for the VERACITY study.
“We are excited to begin enrolling patients in our open label Phase 3 VERACITY clinical trial,” said Mitchell Steiner, MD, Chairman, President and CEO of Veru Inc. “As we have previously reported, in the Phase 1b/2 clinical trial sabizabulin had significant evidence of tumor efficacy including PSA declines and responses as well as objective and durable tumor responses. Furthermore, sabizabulin was well tolerated without neutropenia. In fact, the safety profile of sabizabulin appears to be similar to what is reported in the package inserts for an androgen receptor targeting agent such as enzalutamide or abiraterone. If the Phase 3 is successful, sabizabulin could be the next ‘go to drug’ in the largest and growing unmet medical need in men who have metastatic castration resistant prostate cancer and who have developed progression of prostate cancer while being treated with an androgen receptor targeting agent, but prior to using IV chemotherapy.”
About Veru Inc.
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 disruptor 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, is currently enrolling, and the Phase 3 clinical study is planned to initiate in calendar Q4 2021 to treat hormone sensitive advanced prostate cancer. 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 calendar Q3 2021; 2) Phase 2 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 (≥ 40% AR positivity) in a 2nd line metastatic setting in approximately 106 patients who have failed 1st 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 Q3 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, TRODELVY® monotherapy, and sabizabulin + TRODELVY combination therapy in approximately 156 women with metastatic triple negative breast cancer that have become resistant to at least two systemic chemotherapies including a taxane. 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.
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 U.S. and globally. In the U.S., 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, U.N. 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). An NDA was filed by FDA in April 2021 with a PDUFA date in December 2021. The Company plans to launch through telemedicine and telepharmacy sales channels. To learn more about Veru products, please visit www.verupharma.com.
SOURCE: Veru
Post Views: 23
