Benoti&AR, a KOSDAQ-listed company, announced on the 24th that its affiliate Benobio has received approval from the Human Research Ethics Committee (HREC) in Australia for the Phase 1 clinical trial plan of its new drug candidate for macular degeneration treatment, 'BBRP11001.'


BBRP11001 (BBC1501) is one of Benobio's epigenetic regulation therapy pipelines. It works by binding to BRD proteins within the eye to inhibit angiogenesis and inflammation, showing therapeutic effects for various ophthalmic diseases such as macular degeneration and diabetic retinopathy. The mechanism that simultaneously inhibits angiogenesis and inflammation is a groundbreaking treatment method that can fundamentally treat macular degeneration, and upon completion of development, it is expected to become a first-in-class innovative drug.


This clinical trial will be conducted at five hospitals in Australia, targeting up to 18 patients diagnosed with macular degeneration who have not responded to existing treatments. The dosage will be increased in up to three stages to confirm drug safety and establish the recommended dose. The trial will be conducted through the global clinical research organization Novotech, with completion expected by December 2025.


Macular degeneration is a disease caused by degeneration in the central macula of the retina, leading to gradual vision loss due to photoreceptor damage. Most currently approved macular degeneration treatments are antibody therapies with high production costs. Additionally, many patients show limited vision improvement or develop resistance, increasing the need for more effective treatments.


Lee Inhyun, Vice President of Benobio, stated, “We will do our best to successfully complete the clinical trial and provide better treatment options for patients with macular degeneration,” adding, “Based on excellent clinical results, we plan an early license-out (LO) of BBRP11001.”



Meanwhile, Benobio, established in 2018, is a biotech company developing macular degeneration treatments, anticancer drugs, osteoarthritis treatments, and K-Ras targeted anticancer drugs based on its epigenetic regulation technology 'BENEPIGEN' and artificial intelligence (AI). In May of this year, it was finally selected for the '2024 1st National New Drug Development Project' for new drug development.


This content was produced with the assistance of AI translation services.

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