Veru Announces Appointment of Dr. Erik Swenson and Dr. Robert Schooley to its Infectious Disease Scientific Advisory Board - Seite 2

“The clinical data Veru has generated in COVID-19 induced ARDS and more recently preclinically in smallpox and influenza, additional viral ARDS-related diseases, indicate the Company is poised to potentially provide a therapeutic solution to patients worldwide. I am excited to serve as a member of its Scientific Advisory Board during this major inflection point,” said Robert Schooley, M.D.

Drs. Swenson and Schooley join David D. Ho, M.D., Chairman of Veru’s SAB. David D. Ho, M.D. is the Founding Scientific Director of the Aaron Diamond AIDS Research Center and the Clyde and Helen Wu Professor of Medicine at Columbia University Irving Medical Center, a Member of The National Academy of Medicine, Member of The American Academy of Arts & Sciences, and a Fellow of The American Association for the Advancement of Science. He received his M.D. from Harvard Medical School and has received fourteen honorary doctorates over the course of his career. In his noteworthy research, Dr. Ho discovered the nature of HIV replication, and the resulting innovative combination therapy remarkably enabled patients to manage this disease. In 1996, Dr. Ho was selected by TIME Magazine as man of the year as a doctor who gives hope to millions in the daunting fight against HIV. In addition, Dr. Ho is leading a multi-disciplinary team of physicians, and scientists to advance the development of new drugs that target SARS-CoV-2 mutants.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases.

Oncology program focuses on breast cancer

The Company’s late stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist.

• Enrolling Phase 2b/3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio (abemaciclib).

• Planned Phase 2b/3 study of enobosarm in nonmeasurable bone only metastatic breast cancer.
  

Infectious disease program focuses on viruses that pose serious worldwide global threat

• COVID-19: Sabizabulin is an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and host mediated antiviral properties. Veru has conducted a positive double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. In April 2023, the Company reached agreement with FDA on design of Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. The Company plans to initiate this Phase 3 clinical study in 2H 2023.

• Smallpox and Ebola viruses: The Company is planning a pre-IND meeting with FDA to discuss the development of sabizabulin for smallpox virus and Ebola virus under the Animal Rule FDA regulatory approval pathway.

• Influenza: The Company is planning a Phase 3 clinical trial to evaluate sabizabulin in hospitalized influenza patients at high risk for ARDS.