Dianjing Bio Announces Positive Topline Results from Phase 1b Trial of Trispecific Fusion Antibody EB-105 in Diabetic Macular Edema
Eluminex Biosciences
Ophthalmic Innovative Drug Developer
June 9,Herbal Invested Enterprise Eluminex Biosciences (Suzhou) Limited"hereinafter referred to as"Eluminex Biosciences”) announced its three-target fusion antibody drug EB-105In the first-in-human treatment of patients with diabetic macular edema (DME)A Single Intravitreal Injection, Dose-Escalation Phase Ib Clinical Trial（LOTUS study, Part 1) achieved positive topline results in China.
The trialThirteen DME patients were enrolled at four clinical centers in the United States to evaluate a single intravitreal injection of a low dose.1.6 mg/eye, N=4), China (4.0 mg/eye, N=5), High (8.0 mg/eye, N=4) Three dose levels of EB-105.Subjects received EB-105 injection on Day 1 and were followed up for 3 months.
Key Results:
- Excellent Safety:
No drug-related adverse events, dose-limiting toxicity, or serious adverse events (including intraocular inflammation) were reported during the study period.。 - Significant efficacy:
All dose groups demonstrated pharmacodynamic activity with clinical relevance, characterized by a sustained overall mean improvement in Best Corrected Visual Acuity (BCVA) and a reduction in Central Subfield Thickness (CST) of the macula.。
At Month 3 after a single injection of EB-105, the maximum reductions in CST from baseline were observed to be -103 to -429 µm across three dose levels. The maximum increase in BCVA from baseline was +12 to +21 letters.
Preclinical studies have shown that EB-105 can potently inhibit signaling pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. IL-6 is an inflammatory cytokine that is currently known to play a role in vascular leakage caused by endothelial cell barrier dysfunction. Elevated levels of IL-6 are typically found in the vitreous humor and aqueous humor of patients with diabetic macular edema, diabetic retinopathy, neovascular (wet) age-related macular degeneration, and retinal vein occlusion.
"EB-105 has the potential to represent a new generation of trispecific antibody therapy, allowing retinal specialists to break through the limitations of DME and treat a series of retinal diseases with IL-6 mediated inflammatory pathogenic mechanisms, such as wet age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and uveitic macular edema (UME)," said Dr. Veeral Sheth, principal investigator and clinical assistant professor of ophthalmology at the University of Illinois.
Chief Scientific Officer of Eluminex BiosciencesDr. Wei-Yong Shen said: "The favorable safety profile observed after a single injection, along with the sustained benefits in pharmacodynamic indicators such as improved vision and reduced edema, has been highly encouraging. We anticipate that multiple injections will lead to even more significant clinical benefits—by specifically inhibiting uncontrolled IL-6 mediated inflammation, this approach not only holds promise for patients who are refractory to existing therapies but may also substantially extend the duration of efficacy, significantly surpassing the current 16-week dosing cycle limitation.”
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