Coya Therapeutics, Inc. (NASDAQ: COYA) has welcomed Dr. Michelle Frazier, Ph.D. to its management team as Senior Vice President of Regulatory Affairs. With her extensive regulatory and CMC experience, Dr. Frazier is set to guide the Company through all of its regulatory submissions, including the upcoming IND submission for COYA 302, an exciting and pioneering biologic designed to promote Treg function and possibly treat ALS.
Dr. Frazier is an invaluable addition to Coya Therapeutics, bringing her expertise and experience overseeing the complete regulatory and submission process for biologic drugs from start to finish to the organization. With her deep knowledge of FDA requirements and practices, and her proven track record of successfully leading biologics to FDA approval, she will be a great asset to Coya as they continue to grow. Howard H. Berman, CEO of Coya Therapeutics, expressed his confidence in Dr. Frazier’s ability to bring biologics across the finish line.
Dr. Frazier is thrilled to have the chance to join Coya’s distinguished team and work with their impressive multimodal Treg therapies for the treatment of neurodegenerative diseases. His enthusiasm and commitment to make these breakthrough products a reality for patients and their families, if approved by the regulatory authorities, is unwavering.
About Coya Therapeutics, Inc.
Coya Therapeutics, Inc., a Houston-based clinical-stage biotech, is treating systemic and neuroinflammation through an innovative approach to targeting regulatory T cells (Tregs). Coya’s proprietary investigational product candidate pipeline harnesses leading therapeutic strategies and biologics such as the COYA 300 Series’ COYA 301 and COYA 302, which are designed to expand and enhance Treg function.
By simultaneously eliminating T effector activity and depleting activated macrophages, these treatments have the potential to reduce inflammation and restore healthy immunomodulatory balance. Coya is paving the way for a new generation of treatments, offering a promising new hope for many suffering from otherwise incurable inflammatory diseases.
We are confident in the future of our product candidates and current business plans, and believe that the potential economic value and therapeutic benefits of these products could create exciting opportunities and a strong competitive position in the industry. Our clinical and preclinical trials are ongoing and we look forward to announcing updates and results in due course. Additionally, our aim is to obtain and maintain regulatory approval in order to bring our product to market.
The unknown risks, uncertainties and assumptions of the future have never been more important than they are in today’s world, as we strive to develop and commercialize targeted therapeutics and make strides in our preclinical and clinical trials. We are also laser-focused on the size and growth potential of the markets for our product candidates, as well as the safety profile, rate and degree of market acceptance, and clinical utility of any product candidates.
All of these factors contribute to the success, cost and timing of our development activities, as well as our commercialization, marketing and manufacturing capabilities and strategies. With a goal of obtaining and maintaining intellectual property protection, as well as the need to attract and retain key scientific and/or management personnel, the stakes couldn’t be higher in our race to make breakthroughs in our research and activities.
We live in a dynamic and fiercely competitive environment, and our ability to anticipate and skilfully manage emerging risks is key to the success of our business. At the same time, our forward-looking statements reflect our current expectations and projections about future events and trends, with the aim of achieving our short-term and long-term business objectives.
However, while we are confident in our capacity to assess potential risks, there is always the possibility that actual results could differ materially from those anticipated. For this reason, we remain committed to staying updated on the latest developments and responding accordingly.