- EB-101 is a Novel Second Generation Angiogenic Inhibitor Targeting Multiple VEGF Family Ligands
- FDA Agrees with Proposed First-in-Human Phase 1/2a Study Design
- Investigational New Drug Application Filing Anticipated in 2023
SUZHOU, China and SAN FRANCISCO, CA, January 17, 2022 / Eluminex Biosciences (Suzhou) Limited (Eluminex), an ophthalmology-focused biotechnology company headquartered in Suzhou, China with a US-subsidiary office in San Francisco Bay Area, California announced that it successfully completed the first pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) on December 15, 2021, regarding the nonclinical and clinical development plan for EB-101, a recombinant human Fc fusion protein.
EB-101 is one of the leading investigational multivalent second-generation intravitreal agents in the Eluminex pipeline that are wholly developed and owned by Eluminex Biosciences for the treatment of neovascular age-related macular degeneration (nAMD) and other retinal vascular disorders. This first-in-class biological agent leverages state-of-the-art advances in protein engineering and is specifically designed to address the multifactorial etiology of angiogenesis beyond currently approved anti-VEGF therapies.
Eluminex has obtained alignment with FDA on the nonclinical and clinical development plan for EB-101 to support the IND application and initiation of a first-in-human (FIH) Phase 1/2a clinical trial for the treatment of nAMD in the adult population. FDA agreed with Eluminex proposed scope of the clinical FIH Phase 1/2a clinical trial in nAMD, including the study design, patient population, duration of treatment, and endpoints.
FDA also provided general guidance on clinical development expectations at the time of EB-101 Biologics License Application (BLA) submission.
According to FDA’s pre-IND feedback/guidance, Eluminex Biosciences plans to file an IND for EB-101 to US FDA in 2023.
About Eluminex Biosciences
Eluminex Biosciences (Eluminex) is a privately held clinical-stage biotechnology company focused on both global and regional development and commercialization of innovative therapeutics to fulfill unmet medical needs in the treatment and management of ophthalmic diseases. Eluminex is devoted towards innovating the next generation of first-in-class or best-in-class ocular therapeutics for vision-threatening or lifestyle-limiting ocular diseases. Eluminex has developed a pipeline of multivalent next generation protein therapeutics for retinal diseases (EB-101, EB-102, EB-105, and EB-107) including age-related macular degeneration, macular edema, and diabetic retinopathy; these assets are wholly owned and developed by Eluminex. In addition, Eluminex is currently developing the world’s first recombinant human collagen-derived biosynthetic cornea (EB-301) for the treatment of corneal blindness.
The Eluminex global headquarters and research and development center are in Suzhou BioBAY Industrial Park, China with a US-subsidiary located in the San Francisco Bay Area. Eluminex is supported by three premiere global life science venture funds: Lilly Asia Ventures, Hillhouse Capital Management, and Quan Capital.
For more information, please visit www.eluminexbio.com.
About Age-related Macular Degeneration (AMD)
AMD is a leading cause of vision loss in people over the age of 50 in the industrialized world. Symptoms of AMD include blurred or distorted central vision and black spots (scotomas). There are two forms of AMD – dry and wet. Dry AMD accounts for nearly 85 to 90% of all cases and represents the earliest stages of AMD and is caused by fatty deposits (drusen) in the central retina, called the macula, and often not associated with any vision loss.
About 10 to 15% of patients with dry AMD progress to wet AMD. Wet AMD occurs in later stages of AMD where new blood vessels (neovascular) abnormally form in the back of the retina (choroid) – a process referred to as angiogenesis. These neovascular blood vessels can leak fluid (edema) causing swelling of the retinal tissue and/or bleed abnormally. A potential consequence is the development of irreversible scar tissue and vision loss.
While wet AMD constitutes only 10-15% of all cases of AMD, it accounts for more than 90% of permanent vision-loss in patients with AMD. Risk factors include smoking, obesity, family history, and race. Despite the availability of anti-VEGF drugs to treat nAMD, many patients have only partial response and require frequent injections. An unmet need exists for newer treatments that can improve efficacy and durability of response.
Contact for Investors/Media:
Zhenze John Hu, PhD, MPD