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Rezolute Appoints Leading Ophthalmology Expert, Quan Dong Nguyen, MD, MSc, FAAO, FARVO, to Scientific Advisory Board

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Rezolute, Inc. (RZLT), a clinical-stage biopharmaceutical company, has appointed Dr. Quan Dong Nguyen to its Scientific Advisory Board. Dr. Nguyen, a prominent expert in retinal diseases, will provide strategic counsel for RZ402, an oral plasma kallikrein inhibitor aimed at treating diabetic macular edema (DME). His extensive background includes leading pivotal clinical trials and contributing to the approval of existing therapies such as EYLEA and Lucentis. This addition is expected to enhance Rezolute's clinical development strategy and address unmet needs in DME treatment.

Positive
  • Appointment of Dr. Quan Dong Nguyen strengthens expertise in retinal diseases.
  • Dr. Nguyen's experience in leading clinical trials could accelerate RZ402's development.
  • Focus on addressing unmet needs in diabetic macular edema treatment.
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  • None.

REDWOOD CITY, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing novel therapies for diseases related to chronic glucose imbalance, today announced the addition of Quan Dong Nguyen, MD, MSc, FAAO, FARVO to its Scientific Advisory Board. Dr. Nguyen is a renowned expert in retinal vascular and uveitic diseases and is expected to provide valuable strategic and scientific counsel related to RZ402, the Company’s investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME).

“Dr. Quan Dong Nguyen has a distinguished track record of innovative research leading to new treatments for ophthalmic diseases and we are honored to welcome him to our Scientific Advisory Board,” said Brian Roberts, MD, Head of Clinical Development at Rezolute. “Given his extensive clinical and research experience in uveitis and retinal vascular diseases such as diabetic retinopathy, Dr. Nguyen will be instrumental in guiding the clinical development strategy of RZ402 for the treatment of diabetic macular edema and future indication expansion opportunities.”

Dr. Nguyen is Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine. He is known for his innovative work in early proof-of-concept, first-in-human clinical trials to evaluate potential pharmacotherapeutic agents for retinal vascular and uveitic diseases. Dr. Nguyen serves as principal investigator on multiple clinical trials sponsored by the National Eye Institute and other organizations for macular edema (from diabetes and uveitis), neovascular age-related macular degeneration (AMD), and ocular inflammatory and uveitic diseases. He and his team were among the first clinician scientists in the world to evaluate aflibercept for neovascular AMD and ranibizumab for DME; the initial results of these studies served as the foundation for subsequent trials leading to the approval of EYLEA and Lucentis by the U.S. Food and Drug Administration and other regulatory authorities.

“During the past 15 years, significant advances have been made in the understanding of the pathophysiology and management of DME,” said Dr. Nguyen. “The standards of care have transformed from laser photocoagulation to intravitreal pharmacotherapy, especially with the anti-VEGF therapies. However, significant unmet needs remain due to the high treatment burden of regular injections and refractoriness to these therapies in some patients. Rezolute is pursuing an innovative approach to address DME, and I am eager to contribute to the possibility of an earlier treatment intervention that is convenient, comfortable, and potentially more efficacious for patients. I am delighted and excited to join the Scientific Advisory Board at Rezolute, assisting very dedicated research and clinical teams.”

Dr. Nguyen has published over 300 peer reviewed articles and is on the Editorial Board of several journals, including the Journal of Ophthalmic Infection and Inflammation and Ophthalmic Surgery, Laser, and Imaging – Retina. He was chosen as the Inaugural Editor-in-Chief of American Journal of Ophthalmology Case Reports, which was launched in the fall of 2015 as the companion journal to the American Journal of Ophthalmology. Dr. Nguyen has been elected to many prestigious national and international professional organizations, including the Macula Society, the Retina Society, the American Society of Retina Specialists, the American Uveitis Society, the International Ocular Inflammation Society, the International Uveitis Study Group, the Club Jules Gonin, and the American Ophthalmological Society.

Dr. Nguyen received his BS and MSc in Molecular Biophysics and Biochemistry from Yale University, and his MD from the University of Pennsylvania School of Medicine. He completed his internship in Internal Medicine at the Massachusetts General Hospital, and his residency in Ophthalmology at the Massachusetts Eye and Ear Infirmary, Harvard Medical School. Dr. Nguyen completed fellowships in Immunology and Uveitis at the Massachusetts Eye and Ear Infirmary; Ocular Immunology at the Wilmer Eye Institute of the Johns Hopkins Medical Institutions; and Medical and Surgical Retina at the Schepens Eye Research Institute and the Massachusetts Eye and Ear Infirmary. After completing his education in 2001, Dr. Nguyen joined the faculty at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, as Assistant Professor and then Associate Professor of Ophthalmology and Director of Medical Education. In 2013, he was appointed as the McGaw Endowed Chair in Ophthalmology, Professor and Chairman of the Department of Ophthalmology and the Inaugural Director of the Stanley M. Truhlsen Eye Institute, and Assistant Dean for Translational Research at the University of Nebraska Medical Center, before joining the faculty at Stanford.

About RZ402 and the contact activation kallikrein-kinin system

The contact-activation kallikrein-kinin system promotes increased vascular permeability and inflammation via key downstream mediators, including bradykinin, and activation of the intrinsic pathway of coagulation. Pathophysiologic upregulation of this system has been linked to a variety of diseases which are characterized by vascular dysfunction, including diabetic macular edema.

RZ402 is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME). By inhibiting the formation of kallikrein, RZ402 is designed to block downstream bradykinin production and the pro-inflammatory, pro-coagulant, and fluid-leakage contact-activation cascade.

About Diabetic Macular Edema (DME)

Diabetic retinopathy (DR) affects approximately one third of adults with diabetes and is the leading cause of vision loss in the working age population. DME is a severe vision-threatening complication of DR characterized by swelling of the retina and thickening of the macula, the part of the eye that is responsible for high-resolution vision. Anti-vascular growth factor (anti-VEGF) injections into the eye are the current standard of care for DME, requiring continued administration over long periods of time to preserve vision. Due to their invasive route of administration and occasional serious side effects, there is a tendency to delay treatment until later in the disease course, and long-term compliance with eye injection regimens can be difficult for patients. Coupled with inadequate responsiveness in some patients, this leads to overall undertreatment and suboptimal vision outcomes in DME patients.

About Rezolute, Inc.

Rezolute is advancing novel therapies for diseases caused by chronic glucose imbalance. The Company’s lead clinical asset, RZ358, is in Phase 2b development for treatment of congenital hyperinsulinism (CHI), a rare pediatric endocrine disorder. The Company is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Forward-Looking Statements

This release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.

Media Contact

rezolute@argotpartners.com

Investor Contact

rezolute@argotpartners.com


FAQ

What role will Dr. Quan Dong Nguyen play at Rezolute, Inc.?

Dr. Quan Dong Nguyen will serve on the Scientific Advisory Board, providing strategic and scientific counsel for RZ402, aimed at treating diabetic macular edema.

How might Dr. Nguyen's appointment impact the development of RZ402?

Dr. Nguyen's extensive clinical experience is expected to enhance the clinical development strategy of RZ402 and potentially expedite its progress.

What is RZ402 and how does it relate to diabetic macular edema?

RZ402 is a novel oral plasma kallikrein inhibitor in development for the treatment of diabetic macular edema, a complication of diabetic retinopathy.

What are the qualifications of Dr. Quan Dong Nguyen?

Dr. Nguyen is a Professor of Ophthalmology at Stanford and has led clinical trials for major ophthalmic therapies, making him a valuable asset for Rezolute.

Rezolute, Inc.

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