CytoDyn Hires Top CRO for Phase II Inflammation Study

VANCOUVER, Washington, Aug. 23, 2024 - CytoDyn Inc. (OTCQB: CYDY), a biotechnology company focused on developing leronlimab, a CCR5 antagonist with potential for multiple therapeutic applications, has announced its collaboration with Syneos Health as the contract research organization (CRO) for its upcoming Phase II study. This study aims to explore leronlimab's impact on chronic inflammation.

Syneos Health, known for its comprehensive biopharmaceutical solutions, will assist CytoDyn in progressing through this critical phase of development. The organization has a notable track record, having contributed to the development or commercialization of 92% of novel new drugs approved by the FDA between 2019 and 2023, and 91% of products authorized by the European Medicines Agency.

Dr. Jacob Lalezari, CEO of CytoDyn, expressed enthusiasm about working with Syneos Health. He emphasized that the collaboration aims to generate clinical data to support the use of leronlimab in addressing various medical issues affecting patients worldwide.

CytoDyn is a clinical-stage biotechnology firm dedicated to the development and commercialization of leronlimab. Leronlimab is an investigational humanized IgG4 monoclonal antibody designed to target and bind to the C-C chemokine receptor type 5 (CCR5), a protein present on certain immune system cells. This protein is believed to be involved in various disease processes. The company is studying leronlimab for its potential benefits in treating oncology, inflammation, HIV, and non-alcoholic steatohepatitis (NASH), among other conditions.

Syneos Health is a leading biopharmaceutical solutions organization known for accelerating customer success. The organization leverages its expertise in clinical, medical affairs, and commercial insights to address contemporary market challenges. Syneos Health combines a skilled team with a deep understanding of patient and physician behaviors, alongside market dynamics. Their approach integrates insights, modern technologies, and advanced business practices to expedite the delivery of crucial therapies to patients. The organization is committed to fostering a diverse, equitable, and inclusive culture, benefiting colleagues, customers, patients, communities, and the environment.

CytoDyn's decision to engage Syneos Health underscores its commitment to leveraging top-tier expertise to advance its clinical programs. The collaboration is expected to enhance the development pipeline of leronlimab, potentially offering significant therapeutic solutions for chronic inflammation and other health issues. The data generated from the Phase II study will be pivotal in affirming leronlimab's utility in the medical field, aiming to provide new treatment options for patients globally.

By partnering with Syneos Health, CytoDyn seeks to harness the CRO's extensive experience and capabilities in drug development to bring innovative therapies to market efficiently. This strategic move highlights CytoDyn's dedication to advancing medical science and improving patient outcomes through rigorous clinical research and development.