VERU-100 / Veru Inc - LARVOL DELTA

Clinical Trial of VERU100 for Advanced Prostate Cancer Terminated but Veru Continues Search for Effective Treatments (Best Stocks) - "As of May 19, 2023, the clinical trial of VERU-100 for the treatment of advanced prostate cancer has been terminated due to the failure to achieve endpoints at the current dose level. VERU-100, an injectable GnRH antagonist medication, was undergoing a phase two clinical trial to determine an effective dose for maintaining serum total testosterone levels within castrate range in patients with advanced prostate cancer. Unfortunately, the study did not yield the desired results, leading to its termination....Veru, the company behind VERU-100, remains committed to finding effective treatment options for advanced breast and prostate cancer."

Trial termination • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov) - P1b/2 | N=24 | Terminated | Sponsor: Veru Inc. | N=40 ➔ 24 | Trial completion date: Apr 2023 ➔ Jan 2023 | Active, not recruiting ➔ Terminated; Study terminated as end points were not achieved at current dose level.

Enrollment change • Metastases • Trial completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Veru Reports Fiscal 2022 Fourth Quarter and Full Year Financial Results (GlobeNewswire) - "VERU-100, a Novel Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer: We are enrolling patients in the Phase 2 clinical dose finding trial of VERU-100 for androgen deprivation therapy of advanced prostate cancer. The trial design for a future Phase 3 registrational trial of approximately 100 patients has been agreed upon by the FDA."

Clinical protocol • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov) - P1b/2 | N=40 | Recruiting | Sponsor: Veru Inc. | Trial completion date: Sep 2022 ➔ Apr 2023 | Trial primary completion date: Aug 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov) - P1b/2 | N=40 | Recruiting | Sponsor: Veru Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Trial for Novel Advanced Prostate Cancer Drug Enrolls First Patient (Cure Today) - "'I am excited about the clinical development of VERU-100. While GnRH antagonists are the preferred approach, a long-acting injectable alternative does not exist,' said Dr. Ronald Tutrone, in a release. 'VERU-100 would fill an unmet clinical need and provide an opportunity for the urologist to maintain the continuity of care with our patients and maximize drug compliance for their cancer treatment.'"

Media quote

A Trial of VERU-100 for the Treatment of Advanced Prostate Cancer – Ronald Tutrone (Urotoday) - "Alica Morgans is joined by Ronald Tutrone to provide an update on the clinical trial VERU 100. VERU‑100 is a novel, proprietary long-acting gonadotropin-releasing hormone (GnRH) antagonist peptide 3-month subcutaneous depot formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT)."

Video

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov) - P1b/2 | N=40 | Active, not recruiting | Sponsor: Veru Inc. | Trial completion date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Feb 2022 ➔ Aug 2022

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Veru Announces the Presentation of Updated Data from the Phase 1b/2 Sabizabulin Study in Men with Metastatic Castration Resistant Prostate Cancer at the 2022 ASCO Genitourinary Cancers Symposium (GlobeNewswire) - "Current studies on the two drugs include...Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting); Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting); Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting); Enrolling Phase 3 VERACITY in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy; Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone-sensitive prostate cancer; Planned Phase 2b study of zuclomiphene citrate in men with advanced prostate cancer..."

New P3 trial • Trial status • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • HER2 Negative Breast Cancer • Oncology • Prostate Cancer • Solid Tumor

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov) - P1b/2; N=40; Active, not recruiting; Sponsor: Veru Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Veru Reports Record Fiscal 2021 Full-Year Financial Results (GlobeNewswire) - "Sabizabulin...Phase 2b Clinical Study...is expected to commence in calendar Q1 2022; Enobosarm and Abemaciclib...Phase 3 ENABLAR-2 Clinical Study...We plan to enroll approximately 186 subjects in this Phase 3 clinical study which is expected to commence during the first quarter of calendar year 2022; We intend to conduct a single arm, sabizabulin plus enobosarm combination therapy Phase 2 clinical study in approximately 111 women in calendar Q1 2022; The Phase 2 VERU-100 clinical study is expected to enroll approximately 35 patients. A Phase 3 registration clinical study has been agreed upon with FDA and will enroll approximately 100 men. The Phase 3 clinical study is anticipated to begin in 1H calendar 2022."

Enrollment status • New P3 trial • Trial status • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Triple Negative Breast Cancer

Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone Sensitive Advanced Prostate Cancer (GlobeNewswire) - "VERU-100....the Phase 3 clinical study is planned to initiate in calendar Q4 2021 to treat hormone sensitive advanced prostate cancer."

New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer

Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone Sensitive Advanced Prostate Cancer (GlobeNewswire) - "Veru Inc...announced that it has enrolled the first patient in its Phase 2 clinical trial of VERU-100, a novel, proprietary gonadotropin-releasing hormone (GnRH) antagonist decapeptide, three-month subcutaneous depot injection formulation, for the treatment of hormone sensitive advanced prostate cancer."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov) - P1b/2; N=35; Recruiting; Sponsor: Veru Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Veru Reports Strong Second-Quarter Financial Results Based on Record High FC2 Prescription Revenues - “We anticipate initiation of the Phase 2 clinical trial of VERU-100 androgen deprivation therapy for hormone sensitive advanced prostate cancer this month…A Phase 3 registration clinical trial in approximately 100 men is anticipated to begin in the second half of calendar year 2021. We expect to commence our pivotal enobosarm Phase 3 ARTEST clinical study in the second quarter of calendar year 2021. A Phase 2 study…for the treatment of AR+ER+HER2- metastatic breast cancer…expected to commence in calendar Q3 2021. Sabizabulin is also being evaluated for the treatment of taxane chemotherapy resistant metastatic triple negative breast cancer in a planned Phase 2b clinical study in approximately 200 women expected to begin in calendar Q3 2021…the Company plans to meet with the FDA and to commence a three cohort Phase 2b clinical study in calendar Q3 2021.”

FDA event • New P2b trial • New P3 trial • Trial status • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • HER2 Negative Breast Cancer • Prostate Cancer • Triple Negative Breast Cancer

Veru Reports Record Fiscal 2020 Fourth Quarter and Record Full-Year Financial Results (GlobeNewswire) - "The Company has received input from the FDA and anticipates initiating a Phase 3 VERU-111 VERACITY registration clinical trial during the first quarter of calendar 2021...The Company anticipates initiating a Phase 2 trial to evaluate VERU-100 dosing in the first quarter of calendar year 2021 and a Phase 3 registration clinical trial during the second half of calendar year 2021."

FDA event • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer

Veru Reports Higher Net Revenues for Fiscal 2020 Third Quarter (GlobeNewswire) - "VERU-100, a long acting gonadotropin antagonist peptide 3-month depot formulation, GMP manufacturing is progressing and an IND expected to be submitted next quarter. The Phase 2 dose finding clinical study should start late calendar year Q4 2020 and a Phase 3 pivotal registration clinical study is expected to commence in the second half of calendar year 2021."

IND • New P3 trial • New trial • Genito-urinary Cancer • Oncology • Prostate Cancer

Determination of the ability of a novel, long-acting subcutaneous GnRH antagonist, VERU-100, to castrate without a testosterone surge in a rat model. (ASCO-GU 2020) - "VERU-100 is a novel GnRH antagonist formulation that in this rodent study, with a low injection volume, resulted in undetectable T for at least six months. No surge of T is observed after administration. An IND submission is anticipated in early 2020 for the dose finding Phase 2 trial in men with advanced prostate cancer."

Preclinical

Determination of the ability of a novel, long-acting subcutaneous GnRH antagonist, VERU-100, to castrate without a testosterone surge in a rat model. (ASCO-GU 2020) - "VERU-100 is a novel GnRH antagonist formulation that in this rodent study, with a low injection volume, resulted in undetectable T for at least six months. No surge of T is observed after administration. An IND submission is anticipated in early 2020 for the dose finding Phase 2 trial in men with advanced prostate cancer."

Preclinical

Newly added product (GlobeNewswire) - Preclinical, Oncology, Prostate Cancer

Pipeline update