- Phase 1
- Phase 2
- Phase 3
Diabetic Macular Edema
EB-105 and EB-107
Retina: Wet AMD and Diabetic Macular Edema; Pre-IND
EB-105 and EB-107 are preclinical stage assets under development for diabetic macular edema (DME) and wet age-related macular degeneration (wet AMD). These first-in-class biologics leverage state-of-the-art advances in antibody engineering and are specifically designed to address the multifactorial biology of angiogenesis and diabetic vasculopathy beyond current anti-VEGF therapies. Our goal with these molecules is to provide the next generation of treatment for age- and diabetes-related eye diseases and potentially other anti-VEGF responsive retinal diseases [e.g., diabetic retinopathy (DR), retinal vein occlusion (RVO), and polypoidal choroidal vasculopathy (PCV)], providing improved durability, fewer intravitreal injections and alterative options for patients with sub-optimal or refractory responses to anti-VEGF therapy alone. These molecules are wholly developed and owned by Eluminex Biosciences.
EB-116Retina: Leber’s Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP); Phase 2
EB-116 is a clinical stage, novel, oral therapy for the treatment of a rare form of childhood blindness in patients with LCA or RP caused by mutations of the RPE65 or LRAT gene. EB-116 is regulated as a small molecule pharmaceutical product and is anticipated to enter a global Phase 2b/3 pediatric study in 2H 2022 to confirm its efficacy and safety. Orally administered zuretinol has been previously evaluated in 144 human subjects in 8 clinical studies, including healthy subjects, patients with recessive RPE65/LCA1,2, autosomal dominant RPE651,2, and adults with early age-related macular degeneration (AMD) with poor night vision3, which has demonstrated that zuretinol appears safe and well-tolerated and can rapidly improve visual function.
- Koenekoop RK, Sui R, Sallum J, Ingeborgh van den Born L, Ajlan R, et al. Oral 9-cis retinoid for childhood blindness due to Leber congenital amaurosis caused by RPE65 or LRAT mutations: an open-label Phase 1b trial. Lancet 2014; 384: 1513-20.
- Scholl HPN, Moore AT, Koenekoop RK, Wen Y, Fishman GA, et al. Safety and proof-of-concept study of oral QLT091001 in retinitis pigmentosa due to inherited deficiencies of retinal pigment epithelial 65 protein (RPE65) or lecithin:retinol acyltransferase (LRAT). PLOS One. 2015 Dec 10; 10(12): e0143846.
- Eluminex Biosciences, Ltd (Suzhou), data on file.
Cornea: Corneal Blindness; Phase 3
EB-301 is a novel clinical stage first-in-class biosynthetic cornea derived from recombinant human collagen and is in late-stage development initially for the China market. EB-301 is intended for the treatment of visual acuity deficits associated with corneal blindness due to stable, non-infectious stromal lesions amenable to anterior lamellar keratoplasty (ALK) as an alternative to cadaveric human donor cornea.
A lack of available donor human corneas is a significant issue in China. Approximately 8,000 donor corneal transplants are conducted in China annually but there are an estimated 150,000 to 200,000 new patients per year that are eligible for corneal transplantation. EB-301 has several potential advantages over currently available porcine corneal implants including improved corneal clarity, no need for immunosuppressants, and serve as a tissue scaffold to allow ingrowth of surrounding stromal and epithelial tissue. Prior clinical studies have shown encouraging long term (> 4 years) durability with improved visual acuity and no corneal melt. Eluminex Biosciences has obtained the exclusive global license for the development of EB-301 from FibroGen (South San Francisco, CA).
Fagerholm, et al. Stable corneal regeneration four years after implantation of a cell-free recombinant human collagen scaffold. Biomaterials (2014) 35:2420-27.